Trial Outcomes & Findings for Femoral Nerve Block for Femur Fracture Repair in Pediatrics (NCT NCT01759407)

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

Target enrollment

19 participants

Primary outcome timeframe

30 mins after surgery

Results posted on

2018-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	Femoral Nerve Block Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg Ropivicaine	Standard Anesthetic Management
Overall Study STARTED	10	9
Overall Study COMPLETED	10	7
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Femoral Nerve Block Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg Ropivicaine	Standard Anesthetic Management
Overall Study Protocol Violation	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Femoral Nerve Block n=10 Participants Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg Ropivicaine	Standard Anesthetic Management n=7 Participants	Total n=17 Participants Total of all reporting groups
Age, Continuous	8.1 years STANDARD_DEVIATION 3.5 • n=10 Participants	7.7 years STANDARD_DEVIATION 3.4 • n=7 Participants	8 years STANDARD_DEVIATION 3 • n=17 Participants
Sex: Female, Male Female	2 Participants n=10 Participants	0 Participants n=7 Participants	2 Participants n=17 Participants
Sex: Female, Male Male	8 Participants n=10 Participants	7 Participants n=7 Participants	15 Participants n=17 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 30 mins after surgery

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	Femoral Nerve Block n=10 Participants Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg Ropivicaine	Standard Anesthetic Management n=7 Participants
Post-anesthesia Care Unit (PACU) Pain Scores	0 pain score Interval 0.0 to 0.0	3 pain score Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 1 1/2 hr.

Median end-tidal isoflurane concentration per participant during the average 1 1/2 hr. surgery.

Outcome measures

Outcome measures
Measure	Femoral Nerve Block n=10 Participants Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg Ropivicaine	Standard Anesthetic Management n=7 Participants
Intraoperative End-tidal Isoflurane %	1.1 percentage of isoflurane Interval 1.0 to 1.4	1.5 percentage of isoflurane Interval 1.0 to 1.7

SECONDARY outcome

Timeframe: From PACU discharge until first opioid dose on the ward, assessed up to 24 hours

Median time between PACU discharge and first opioid dose on the ward.

Outcome measures

Outcome measures
Measure	Femoral Nerve Block n=10 Participants Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg Ropivicaine	Standard Anesthetic Management n=7 Participants
Time to First Opioid Dose	3.3 hours Interval 2.8 to 5.3	3.8 hours Interval 2.9 to 8.1

Adverse Events

Femoral Nerve Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Anesthetic Management

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

Nicole Elsey, MD

Nationwide Children's Hospital

Phone: 614-722-4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place