Analgesic Efficacy After Umbilical Hernia Repair in Children

Umbilical Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578136
• Other study ID #: 2006-10-4980
• Status: Completed
• Phase: N/A
• First received: December 18, 2007
• Last updated: July 30, 2014
• Start date: November 2006
• Est. completion date: December 2011

Study information

• Verified date: July 2014
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Male or female subjects ages > 5 to < 18 years.

2. American Society of Anesthesiology (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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Umbilical
• Umbilical Hernia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	The Children's hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Children's Anesthesiology Associates, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	total postoperative opioid and any additional analgesic medications.	immediate to 24 hour post-operatively	No
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.	difference in time to rescue analgesic and the differences in side effects for the two groups.	immediate to 24 hours post-operatively	No