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Analgesic Efficacy After Umbilical Hernia Repair in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00578136
Recruitment Status : Completed
First Posted : December 20, 2007
Results First Posted : August 15, 2014
Last Update Posted : August 15, 2014
Children's Anesthesiology Associates, Ltd.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Umbilical Hernia Drug: Bupivacaine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (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
Study Start Date : November 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00578136

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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.
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Principal Investigator: Harshad Gurnaney, MBBS Children's Hospital of Philadelphia
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Responsible Party: Children's Hospital of Philadelphia Identifier: NCT00578136    
Other Study ID Numbers: 2006-10-4980
First Posted: December 20, 2007    Key Record Dates
Results First Posted: August 15, 2014
Last Update Posted: August 15, 2014
Last Verified: July 2014
Keywords provided by Children's Hospital of Philadelphia:
Rectus Sheath
Local infiltration
Pain Control
Additional relevant MeSH terms:
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Hernia, Umbilical
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents