Trial Outcomes & Findings for Caudal Versus Rectus Sheath Study (NCT NCT01394523)

Results Overview

Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

39 participants

Primary outcome timeframe

30 minutes

Results posted on

2017-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Caudal Epidural The caudal epidural block was delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL. Bupivacaine: 0.25% or 0.5%	Rectus Sheath The rectus sheath block was performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance. Bupivacaine: 0.25% or 0.5%	Local The surgeon injected either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion. Bupivacaine: 0.25% or 0.5%
Overall Study STARTED	13	13	13
Overall Study COMPLETED	12	13	13
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Caudal Epidural The caudal epidural block was delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL. Bupivacaine: 0.25% or 0.5%	Rectus Sheath The rectus sheath block was performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance. Bupivacaine: 0.25% or 0.5%	Local The surgeon injected either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion. Bupivacaine: 0.25% or 0.5%
Overall Study Unable to place block	1	0	0

Baseline Characteristics

Caudal Versus Rectus Sheath Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Caudal Epidural n=13 Participants The caudal epidural block will be delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL. Bupivacaine: 0.25% or 0.5%	Rectus Sheath n=13 Participants The rectus sheath block will be performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance. Bupivacaine: 0.25% or 0.5%	Local n=13 Participants The surgeon will inject either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion. Bupivacaine: 0.25% or 0.5%	Total n=39 Participants Total of all reporting groups
Age, Continuous	4.2 years STANDARD_DEVIATION 1.5 • n=5 Participants	4.3 years STANDARD_DEVIATION 1.6 • n=7 Participants	4.6 years STANDARD_DEVIATION 1.2 • n=5 Participants	4.4 years STANDARD_DEVIATION 1.4 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	22 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	17 Participants n=4 Participants

PRIMARY outcome

Timeframe: 30 minutes

Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.

Outcome measures

Outcome measures
Measure	Caudal Epidural n=12 Participants The caudal epidural block was delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL. Bupivacaine: 0.25% or 0.5%	Rectus Sheath n=13 Participants The rectus sheath block was performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance. Bupivacaine: 0.25% or 0.5%	Local n=13 Participants The surgeon injected either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion. Bupivacaine: 0.25% or 0.5%
Post-operative Pain Score	2.9 pain score Standard Deviation 3.3	3.1 pain score Standard Deviation 3.1	2.1 pain score Standard Deviation 2.7

Adverse Events

Caudal Epidural

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rectus Sheath

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Local

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

Tarun Bhalla, MD

Nationwide Children's Hospital

Phone: 6147224200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place