Trial Outcomes & Findings for A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants (NCT NCT00756600)

NCT ID: NCT00756600

Last Updated: 2020-04-29

Results Overview

The primary outcome will be the Wechsler Preschool and Primary Scale of Intelligence-Third Edition (WPPSI-III) full scale IQ score. Verbal, visuo-spatial and processing speed skills are incorporated into the Full Scale IQ score, which is indicative of general intellectual ability. Minimum score: 45 Maximum score:145 Higher scores are associated with higher IQ scores (better outcome). Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 643 participants
• Primary outcome timeframe: At 5 years chronological age
• Results posted on: 2020-04-29

Participant Flow

There are no significant events that occur after enrollment and before randomization.

Participant milestones

Measure	Regional Anesthesia Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Overall Study STARTED	287	356
Overall Study COMPLETED	287	356
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Regional Anesthesia n=287 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=356 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.	Total n=643 Participants Total of all reporting groups
Age, Categorical <=18 years	287 Participants n=287 Participants	356 Participants n=356 Participants	643 Participants n=643 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=287 Participants	0 Participants n=356 Participants	0 Participants n=643 Participants
Age, Categorical >=65 years	0 Participants n=287 Participants	0 Participants n=356 Participants	0 Participants n=643 Participants
Age, Continuous	68.9 days STANDARD_DEVIATION 30.8 • n=287 Participants	71.1 days STANDARD_DEVIATION 31.7 • n=356 Participants	70 days STANDARD_DEVIATION NA • n=643 Participants
Sex: Female, Male Female	55 Participants n=287 Participants	52 Participants n=356 Participants	107 Participants n=643 Participants
Sex: Female, Male Male	232 Participants n=287 Participants	304 Participants n=356 Participants	536 Participants n=643 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment New Zealand	7 participants n=205 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.	9 participants n=242 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.	16 participants n=447 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.
Region of Enrollment Canada	10 participants n=205 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.	20 participants n=242 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.	30 participants n=447 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.
Region of Enrollment Netherlands	19 participants n=205 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.	17 participants n=242 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.	36 participants n=447 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.
Region of Enrollment United States	34 participants n=205 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.	52 participants n=242 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.	86 participants n=447 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.
Region of Enrollment Italy	45 participants n=205 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.	50 participants n=242 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.	95 participants n=447 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.
Region of Enrollment United Kingdom	27 participants n=205 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.	22 participants n=242 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.	49 participants n=447 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.
Region of Enrollment Australia	63 participants n=205 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.	72 participants n=242 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.	135 participants n=447 Participants • Not all patients returned for their follow up visit. For this reason, only 205 participants in the "Regional Anesthesia" group and 242 participants in the "General Anesthesia" group total were included in the published analysis. The number of participants from each region were the only ones ultimately analyzed and published.

PRIMARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

The primary outcome will be the Wechsler Preschool and Primary Scale of Intelligence-Third Edition (WPPSI-III) full scale IQ score. Verbal, visuo-spatial and processing speed skills are incorporated into the Full Scale IQ score, which is indicative of general intellectual ability.

Minimum score: 45 Maximum score:145 Higher scores are associated with higher IQ scores (better outcome).

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Outcome measures

Measure	Regional Anesthesia n=205 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=242 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Full Scale IQ Score	100.5 score on scale Standard Deviation 14.3	100.1 score on scale Standard Deviation 15.3

SECONDARY outcome

Timeframe: At 5 years corrected age.

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Verbal IQ

Minimum possible score:45 Maximum possible score:145

A higher score indicates higher verbal IQ (better outcome).

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Outcome measures

Measure	Regional Anesthesia n=206 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=240 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Verbal IQ	101.8 score on scale Standard Deviation 14.7	100.9 score on scale Standard Deviation 15.4

SECONDARY outcome

Timeframe: At 5 years corrected age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Performance IQ

Minimum possible score:45 Maximum possible score:145

A higher score indicates a higher performance IQ (better outcome).

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Outcome measures

Measure	Regional Anesthesia n=206 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=241 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Performance IQ	100.7 score on scale Standard Deviation 15.2	101.2 score on scale Standard Deviation 15.9

SECONDARY outcome

Timeframe: At 5 years corrected age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Processing speed quotient

Minimum possible score:45 Maximum possible score:145

A higher score indicates a better outcome.

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Outcome measures

Measure	Regional Anesthesia n=196 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=220 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Processing Speed Quotient	95.8 score on scale Standard Deviation 14.5	96.3 score on scale Standard Deviation 15.4

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Developmental Neuropsychological Assessment second edition (NEPSY-II) sub test: Sentence Repetition scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Outcome measures

Measure	Regional Anesthesia n=175 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=202 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Sentence Repetition Scaled Score	9.7 score on scale Standard Deviation 2.9	9.7 score on scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: At 5 years corrected age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Auditory Attention combined scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Outcome measures

Measure	Regional Anesthesia n=167 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=183 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Auditory Attention Combined Scaled Score	9.0 score on scale Standard Deviation 2.7	9.3 score on scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: At 5 years corrected age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Statue scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Outcome measures

Measure	Regional Anesthesia n=160 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=182 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Statue Scaled Score	8.8 score on scale Standard Deviation 3.5	8.6 score on scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: At 5 years corrected age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Inhibition combined scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Outcome measures

Measure	Regional Anesthesia n=150 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=160 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Inhibition Combined Scaled Score	8.3 score on scale Standard Deviation 3.1	8.9 score on scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: At 5 years corrected age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Word Generation Scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Outcome measures

Measure	Regional Anesthesia n=182 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=199 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Word Generation Scaled Score	9.4 score on scale Standard Deviation 3.4	9.3 score on scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: At 5 years corrected age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Affect Recognition scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Outcome measures

Measure	Regional Anesthesia n=174 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=208 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Affect Recognition Scaled Score	10.6 score on scale Standard Deviation 2.8	10.4 score on scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: At 5 years corrected age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Memory for Names and Memory for Names Delay

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Outcome measures

Measure	Regional Anesthesia n=180 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=208 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Memory for Names and Memory for Names Delay	8.1 score on scale Standard Deviation 3.2	8.1 score on scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: At 5 years corrected age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Theory of Mind scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Outcome measures

Measure	Regional Anesthesia n=163 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=178 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Theory of Mind Scaled Score	9.8 score on scale Standard Deviation 2.9	9.3 score on scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: At 5 years corrected age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Speeded Naming combined scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Outcome measures

Measure	Regional Anesthesia n=132 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=142 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Speeded Naming Combined Scaled Score	9.7 score on scale Standard Deviation 3.0	9.8 score on scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: At 5 years corrected age

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test:Fingertip tapping repetitions scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score is indicative of a better outcome.

Outcome measures

Measure	Regional Anesthesia n=180 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=195 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Fingertip Tapping Repetitions Scaled Score	9.8 score on scale Standard Deviation 3.4	9.7 score on scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: At 5 years corrected age

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: fingertip tapping sequences scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Outcome measures

Measure	Regional Anesthesia n=173 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=183 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Fingertip Tapping Sequences Scaled Score	8.1 score on scale Standard Deviation 3.4	7.7 score on scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: At 5 years corrected age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Design Copy Process Total Scaled Score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Outcome measures

Measure	Regional Anesthesia n=172 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=207 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Design Copy Process Total Scaled Score	9.6 score on a scale Standard Deviation 3.4	9.9 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Weschler Individual Achievement Test (WIAT-II Abbreviated) to assess the academic skills of the child: Word Reading standard score

Minimum possible score: 45 Maximum possible score: 145

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

A higher score indicates a better outcome.

Outcome measures

Measure	Regional Anesthesia n=147 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=167 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Word Reading Standard Score	92.3 score on scale Standard Deviation 18.1	92.8 score on scale Standard Deviation 211

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Weschler Individual Achievement Test (WIAT-II Abbreviated) to Assess the Academic Skills of the Child: Numerical Operations standard score

Minimum possible score: 45 Maximum possible score: 145

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

A higher score indicates a better outcome.

Outcome measures

Measure	Regional Anesthesia n=146 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=161 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Numerical Operations Standard Score	98.8 score on scale Standard Deviation 16.2	96.2 score on scale Standard Deviation 20.8

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Weschler Individual Achievement Test (WIAT-II Abbreviated) to Assess the Academic Skills of the Child: Spelling standard score

Minimum possible score: 45 Maximum possible score: 145

A higher score indicates a better outcome.

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Outcome measures

Measure	Regional Anesthesia n=141 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=152 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Spelling Standard Score	90.1 score on scale Standard Deviation 13.2	90.8 score on scale Standard Deviation 16.5

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Children's Memory Scale (CMS):Numbers Total scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Outcome measures

Measure	Regional Anesthesia n=194 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=229 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Numbers Total Scaled Score	8.3 score on scale Standard Deviation 3.2	8.1 score on scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Children's Memory Scale (CMS): Word Lists 1 (learning) scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Outcome measures

Measure	Regional Anesthesia n=186 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=224 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Word Lists 1 (Learning) Scaled Score	8.3 score on scale Standard Deviation 3.4	8.6 score on scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Children's Memory Scale (CMS): Memory and learning Word Lists II (delayed) scaled score

Minimum possible score: 1 Maximum possible score: 19

A higher score indicates a better outcome.

Outcome measures

Measure	Regional Anesthesia n=178 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=209 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Memory and Learning Word Lists II (Delayed) Scaled Score	9.7 score on scale Standard Deviation 2.8	9.6 score on scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Full title: The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function

Preschool Version Parent Form (BRIEF-P) to measure behavioural executive abilities.

Minimum possible score: 40 Maximum possible score: 110

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

A higher score indicates a worse outcome.

Outcome measures

Measure	Regional Anesthesia n=198 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=232 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function	48.4 score on scale Standard Deviation 12.5	51.5 score on scale Standard Deviation 13.4

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Full title: The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System

• 2nd edition (ABAS-II) to measure the child's adaptive behavior.

Minimum possible score: 45 Maximum possible score: 145

A higher score indicates a better outcome.

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Outcome measures

Measure	Regional Anesthesia n=168 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=200 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System	95.9 score on scale Standard Deviation 16.3	94.1 score on scale Standard Deviation 16.5

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Child Behaviour Checklist Caregiver Questionnaire (CBCL): Total Problems Score to measure behavioural problems

Minimum possible score: 40 Maximum possible score: 100

A higher score indicates a worse outcome.

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Outcome measures

Measure	Regional Anesthesia n=215 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=254 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Total Problems Score	44.6 score on scale Standard Deviation 11.7	46.7 score on scale Standard Deviation 12.5

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Child Behaviour Checklist Caregiver Questionnaire (CBCL): CBCL internalising problems T score

Minimum possible score: 40 Maximum possible score: 100

A higher score indicates a worse outcome.

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Outcome measures

Measure	Regional Anesthesia n=215 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=254 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Internalising Problems T Score	46.1 score on scale Standard Deviation 12.5	48.0 score on scale Standard Deviation 12.5

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Child Behaviour Checklist Caregiver Questionnaire (CBCL): externalising problems T score

Minimum possible score: 40 Maximum possible score: 100

A higher score indicates a worse outcome.

Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Outcome measures

Measure	Regional Anesthesia n=215 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=254 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Externalising Problems T Score	44.0 score on scale Standard Deviation 10.7	45.8 score on scale Standard Deviation 11.9

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Speech or language issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

Outcome measures

Measure	Regional Anesthesia n=214 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=257 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Speech or Language Interventions	18 participants	17 participants

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Psychomotor issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

Outcome measures

Measure	Regional Anesthesia n=214 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=257 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Psychomotor Interventions	8 participants	6 participants

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Child has global developmental delay. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

Outcome measures

Measure	Regional Anesthesia n=204 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=238 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Number of Participants With Global Developmental Delay	2 participants	0 participants

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Child has been diagnosed with Attention Deficit Hyperactivity Disorder. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

Outcome measures

Measure	Regional Anesthesia n=214 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=257 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Number of Participants With Attention Deficit Hyperactivity Disorder	3 participants	4 participants

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Child has been diagnosis with Autism Spectrum Disorder. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

Outcome measures

Measure	Regional Anesthesia n=211 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=251 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Number of Participants With Autism Spectrum Disorder	5 participants	11 participants

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Child has a hearing abnormality. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

Outcome measures

Measure	Regional Anesthesia n=213 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=252 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Number of Participants With a Hearing Abnormality	8 participants	11 participants

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Child has a visual defect in either eye. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

Outcome measures

Measure	Regional Anesthesia n=213 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=254 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Number of Participants With a Visual Defect in Either Eye	21 participants	31 participants

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Child has a hearing aid. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

Outcome measures

Measure	Regional Anesthesia n=211 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=251 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Number of Participants With a Hearing Aid	0 participants	3 participants

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Child is legally blind. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

Outcome measures

Measure	Regional Anesthesia n=212 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=254 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Number of Participants Who Are Legally Blind	0 participants	0 participants

SECONDARY outcome

Timeframe: At 5 years chronological age

Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.

Child has cerebral palsy. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

Outcome measures

Measure	Regional Anesthesia n=213 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=254 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Number of Participants Who Have Cerebral Palsy	1 participants	3 participants

SECONDARY outcome

Timeframe: At 5 years chronological age

Whether or not a parent is aware of which treatment group their child was allocated to. This variable will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

Outcome measures

Measure	Regional Anesthesia n=287 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=356 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Parents' Awareness of Group Allocation	105 caregivers	118 caregivers

SECONDARY outcome

Timeframe: At 5 years chronological age

These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

Outcome measures

Measure	Regional Anesthesia n=287 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=356 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Awareness of Group Allocation by Psychologist	7 psychologists	7 psychologists

SECONDARY outcome

Timeframe: At 5 years chronological age

Outcome measures

Measure	Regional Anesthesia n=287 Participants Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.	General Anesthesia n=356 Participants General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Awareness of Group Allocation by Pediatrician	13 Pediatricians	13 Pediatricians

Adverse Events

Regional Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

General Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Mary Ellen McCann

Boston Children's Hospital Anesthesia Foundation

Phone: 6173557737

Email: mary.mccann@childrens.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place