Overview

This trial is active, not recruiting.

Condition umbilical hernia
Treatment bupivacaine
Sponsor Children's Hospital of Philadelphia
Collaborator Children's Anesthesiology Associates, Ltd.
Start date November 2006
End date December 2009
Trial size 90 participants
Trial identifier NCT00578136, 2006-10-4980

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
bupivacaine
Bupivacaine, 0.25%, dose amount is weight based, injection is divided per dise with rectus sheath injection or with local infiltration of the operative area.
(Active Comparator)
2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
bupivacaine
Bupivacaine, 0.25%, dose amount is weight based, injection is divided per dise with rectus sheath injection or with local infiltration of the operative area.

Primary Outcomes

Measure
To compare the amount of intravenous and oral opioids used by patients between the patients who receive a rectus sheath nerve block and those who receive local infiltration of the surgical site for postoperative analgesia.
time frame: immediate to 24 hour post-operatively

Secondary Outcomes

Measure
To determine the duration of analgesia based on time to first rescue med, the quality of analgesia based on modified FACES scale, the incidence of side effects: Nausea, Vomiting, Pruritus, and assess patient satisfaction with pain management.
time frame: immediate to 24 hours post-operatively

Eligibility Criteria

Male or female participants from 5 years up to 17 years old.

Inclusion Criteria: 1. Male or female subjects ages > 5 to < 18 years. 2. ASA physical status 1 or 2. 3. Patients who undergo an umbilical hernia repair at CHOP. Exclusion Criteria: 1. Parents/patients refusal to the placement of a rectus sheath nerve block. 2. Subjects with allergy to bupivacaine. 3. Patients who are developmentally delayed which precludes their participation in pain scale reporting. 4. Parents who do not comprehend English sufficiently well to read the consent and ask questions.

Additional Information

Official title A Randomized-Double Blinded Trial Comparing the Analgesic Efficacy and Side Effects of Rectus Sheath Block vs. Infiltration of Surgical Site for Post Operative Pain Control After Umbilical Hernia Repair Surgery
Principal investigator Harshad Gurnaney, MBBS
Description Umbilical hernia repair, a common Day Surgery procedure in children, is associated with considerable postoperative discomfort. The patient has to meet certain discharge criteria such as tolerating liquids, adequate level of analgesia, etc., prior to being discharged from the day surgery unit. Currently, both rectus sheath block and local infiltration of the surgical site are used for providing post-operative analgesia for umbilical hernia repair surgery. The local infiltration can only be done at the end of the surgical procedure as it could alter the planes of the surgical field if performed preoperatively. We believe that the analgesia provided prior to the surgical incision will decrease the amount of intraoperative and postoperative opioids used and the subsequent side effects of these medications (5,6). The rectus sheath block, a regional anesthetic technique, offers possible improved pain management following umbilical hernia repair in a recent observational study (1-3,7). We will perform a double-blinded, randomized study to compare the efficacy of rectus sheath block and surgical infiltration in providing postoperative analgesia.
Trial information was received from ClinicalTrials.gov and was last updated in February 2011.
Information provided to ClinicalTrials.gov by Children's Hospital of Philadelphia.