Analgesic Efficacy After Umbilical Hernia Repair in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Children's Hospital of Philadelphia.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Children's Anesthesiology Associates, Ltd.
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00578136
First received: December 18, 2007
Last updated: February 14, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Umbilical Hernia
Drug: Bupivacaine

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

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2006
Estimated Study Completion Date: December 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578136

Locations
United States, Pennsylvania
The Children's hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Anesthesiology Associates, Ltd.
Investigators
Principal Investigator: Harshad Gurnaney, MBBS Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Harshad Gurnaney, MD, The Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00578136     History of Changes
Other Study ID Numbers: 2006-10-4980
Study First Received: December 18, 2007
Last Updated: February 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Rectus Sheath
Local infiltration
Pain Control

Additional relevant MeSH terms:
Hernia
Hernia, Umbilical
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal
Analgesics
Bupivacaine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 20, 2014