Clinical Trial: Analgesic Efficacy After Umbilical Hernia Repair in Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.


Sponsor: Children's Hospital of Philadelphia

Current Primary Outcome: 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. [ Time Frame: immediate to 24 hour post-operatively ]

total postoperative opioid and any additional analgesic medications.


Original Primary Outcome: 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 ]

Current Secondary Outcome: 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. [ Time Frame: immediate to 24 hours post-operatively ]

difference in time to rescue analgesic and the differences in side effects for the two groups.


Original Secondary Outcome: 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 ]

Information By: Children's Hospital of Philadelphia

Dates:
Date Received: December 18, 2007
Date Started: November 2006
Date Completion:
Last Updated: July 30, 2014
Last Verified: July 2014