Analgesic Efficacy After Umbilical Hernia Repair in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Umbilical Hernia
• Intervention / Treatment: Drug: Bupivacaine

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; 1) One group will receive the rectus sheath block prior to Umbilical hernia repair.	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.
Active Comparator: 2; 2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Children's Anesthesiology Associates, Ltd.
• Investigators: Principal Investigator: Harshad Gurnaney, MBBS, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: December 18, 2007
• First Submitted That Met QC Criteria: December 19, 2007
• First Posted (Estimate): December 20, 2007

Study Record Updates

• Last Update Posted (Estimate): August 15, 2014
• Last Update Submitted That Met QC Criteria: July 30, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Pain Control; Local infiltration; Rectus Sheath
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia, Ventral; Hernia; Hernia, Umbilical; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2006-10-4980