Trial Outcomes & Findings for Efficacy Study of Femoral Nerve Block in Children With a Femur Fracture (NCT NCT01294098)

Results Overview

We will be looking at post-operative pain scores to see if those in the intervention group have lower pains scores. Wong Baker FACES pain scale:The faces correspond to numeric values from 0-5. This scale can be documented with the numeric value. The pain scale goes from 0-5 with 0 being no pain and 5 being the worst pain. 0: No Hurt 1. Hurts a little bit 2. Hurts a little more 3. Hurts even more 4. Hurts a whole lot 5. Hurts worst

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

with in the first 24 hours

Results posted on

2018-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	PCA and Femoral Nerve Block this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively Marcaine: 0.75 cc/kg of 1/4% Marcaine	PCA + Hematoma Block patient will receive hematoma block during surgery Marcaine: 0.75 cc/kg of 1/4% Marcaine
Overall Study STARTED	1	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy Study of Femoral Nerve Block in Children With a Femur Fracture

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PCA Only this group will only get a pain control anesthesia pump to use for post-operative pain	PCA and Femoral Nerve Block n=1 Participants this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively Marcaine: 0.75 cc/kg of 1/4% Marcaine	PCA + Hematoma Block n=1 Participants patient will receive hematoma block during surgery Marcaine: 0.75 cc/kg of 1/4% Marcaine	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	—	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	—	13 years n=7 Participants	8 years n=5 Participants	10.5 years n=4 Participants
Sex: Female, Male Female	—	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	—	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants

PRIMARY outcome

Timeframe: with in the first 24 hours

We will be looking at post-operative pain scores to see if those in the intervention group have lower pains scores. Wong Baker FACES pain scale:The faces correspond to numeric values from 0-5. This scale can be documented with the numeric value. The pain scale goes from 0-5 with 0 being no pain and 5 being the worst pain. 0: No Hurt 1. Hurts a little bit 2. Hurts a little more 3. Hurts even more 4. Hurts a whole lot 5. Hurts worst

Outcome measures

Outcome measures
Measure	PCA Only this group will only get a pain control anesthesia pump to use for post-operative pain	PCA and Femoral Nerve Block n=1 Participants this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively Marcaine: 0.75 cc/kg of 1/4% Marcaine	PCA + Hematoma Block n=1 Participants patient will receive hematoma block during surgery Marcaine: 0.75 cc/kg of 1/4% Marcaine
Post-operative Pain Scores	—	1.1 units on a scale Interval 0.0 to 5.0	.11 units on a scale Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: within first 24 horus

We will be looking at the amount of narcotics used after surgery to see if there is a reduction in narcotic use

Outcome measures

Outcome measures
Measure	PCA Only this group will only get a pain control anesthesia pump to use for post-operative pain	PCA and Femoral Nerve Block n=1 Participants this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively Marcaine: 0.75 cc/kg of 1/4% Marcaine	PCA + Hematoma Block n=1 Participants patient will receive hematoma block during surgery Marcaine: 0.75 cc/kg of 1/4% Marcaine
Post-operative Narcotic Use	—	14.4 mg	3.2 mg

SECONDARY outcome

Timeframe: first year

we will following patients to look at fracture healing post-operatively

Outcome measures

Outcome measures
Measure	PCA Only this group will only get a pain control anesthesia pump to use for post-operative pain	PCA and Femoral Nerve Block n=1 Participants this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively Marcaine: 0.75 cc/kg of 1/4% Marcaine	PCA + Hematoma Block n=1 Participants patient will receive hematoma block during surgery Marcaine: 0.75 cc/kg of 1/4% Marcaine
Femur Fracture Healing	—	24 weeks	10 weeks

Adverse Events

PCA Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PCA and Femoral Nerve Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PCA + Hematoma Block

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

Lauren Westlund

Washington University School of Medicine

Phone: 314-454-5345

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place