N/A
N=54
Analgesic Efficacy After Umbilical Hernia Repair in Children
Umbilical Hernia
Bottom Line
View on ClinicalTrials.gov: NCT00578136 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: 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; 0.13 mg kg-1 — p=0.008
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bupivacaine (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; 0.13 | 0.008 sig |
| SECONDARY 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; 32.35 | — |
Summary
Umbilical hernia repair is a common painful outpatient procedure performed in children. Often analgesia for this procedure is provided by using local infiltration of the surgical site by the surgeons and perioperative opioids and NSAIDS both IV and orally. The use of opioids can cause adverse side effects which include, but are not limited to nausea, vomiting, itching, and respiratory depression, etc. The rectus sheath block can be performed in these patients to decrease their post operative pain.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects ages > 5 to < 18 years.
- American Society of Anesthesiology (ASA)physical status 1 or 2.
- Patients who undergo an umbilical hernia repair at CHOP.
Exclusion Criteria
- Parents/patients refusal to the placement of a rectus sheath nerve block.
- Subjects with allergy to bupivacaine.
- Patients who are developmentally delayed which precludes their participation in pain scale reporting.
- Parents who do not comprehend English sufficiently well to read the consent and ask questions.
Data sourced from ClinicalTrials.gov (NCT00578136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.