Trial Outcomes & Findings for Analgesic Efficacy After Umbilical Hernia Repair in Children (NCT NCT00578136)
NCT ID: NCT00578136
Last Updated: 2014-08-15
Results Overview
total postoperative opioid and any additional analgesic medications.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
immediate to 24 hour post-operatively
Results posted on
2014-08-15
Participant Flow
52 patients completed the study, having hernia repair as a day-surgery procedure.
We screened 120 subjects and excluded 66, 35 patients did not fit the criteria and 31 patients declined to participate. 54 subjects were randomized to receive either a rectus sheath block or local anesthetic infiltration. Two randomized subjects did not get the intervention. 52 subjects did get the intervention - 26 in each arm.
Participant milestones
| Measure |
Rectus Sheath Block
1\) One group will receive the rectus sheath block prior to Umbilical hernia repair.
|
Local Infiltration
2\) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Rectus Sheath Block
1\) One group will receive the rectus sheath block prior to Umbilical hernia repair.
|
Local Infiltration
2\) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
|
|---|---|---|
|
Overall Study
Not given intervention
|
1
|
1
|
Baseline Characteristics
Analgesic Efficacy After Umbilical Hernia Repair in Children
Baseline characteristics by cohort
| Measure |
Rectus Sheath Block
n=26 Participants
1\) One group will receive the rectus sheath block prior to Umbilical hernia repair.
|
Local Infiltration
n=26 Participants
2\) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
26 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
7.7 years
STANDARD_DEVIATION .88 • n=93 Participants
|
7.9 years
STANDARD_DEVIATION .88 • n=4 Participants
|
7.8 years
STANDARD_DEVIATION .88 • n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=93 Participants
|
26 participants
n=4 Participants
|
52 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: immediate to 24 hour post-operativelytotal postoperative opioid and any additional analgesic medications.
Outcome measures
| Measure |
Rectus Sheath Block
n=26 Participants
1\) One group will receive the rectus sheath block prior to Umbilical hernia repair.
|
Local Infiltration
n=26 Participants
2\) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
|
|---|---|---|
|
The Amount of Intravenous and Oral Opioids Used by Patients Who Receive a Rectus Sheath Nerve Block and Those Who Receive Local Infiltration of the Surgical Site for Postoperative Analgesia.
|
0.07 mg kg-1
Interval 0.05 to 0.09
|
0.13 mg kg-1
Interval 0.09 to 0.17
|
SECONDARY outcome
Timeframe: immediate to 24 hours post-operativelyPopulation: Time to first rescue dose of opioid medication.
difference in time to rescue analgesic and the differences in side effects for the two groups.
Outcome measures
| Measure |
Rectus Sheath Block
n=26 Participants
1\) One group will receive the rectus sheath block prior to Umbilical hernia repair.
|
Local Infiltration
n=26 Participants
2\) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
|
|---|---|---|
|
The Duration of Analgesia Based on Time to First Rescue Med, the Quality of Analgesia Based on Modified FACES Scale, and the Incidence of Side Effects: Nausea, Vomiting, Pruritus, and Assess Patient Satisfaction With Pain Management.
|
49.70 minutes
Standard Deviation 36.94
|
32.35 minutes
Standard Deviation 29.39
|
Adverse Events
Rectus Sheath Block
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Local Infiltration
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rectus Sheath Block
n=26 participants at risk
1\) One group will receive the rectus sheath block prior to Umbilical hernia repair.
|
Local Infiltration
n=26 participants at risk
2\) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
7.7%
2/26 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
7.7%
2/26 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
Additional Information
Harshad Gurnaney, MBBS, MPH
The Children's Hospital of Philadelphia
Phone: 267-426-5850
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place