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Analgesic Efficacy After Umbilical Hernia Repair in Children

Primary Purpose

Umbilical Hernia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Umbilical Hernia focused on measuring Rectus Sheath, Local infiltration, Pain Control

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Children's hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

1) One group will receive the rectus sheath block prior to Umbilical hernia repair.

2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 18, 2007
Last Updated
July 30, 2014
Sponsor
Children's Hospital of Philadelphia
Collaborators
Children's Anesthesiology Associates, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00578136
Brief Title
Analgesic Efficacy After Umbilical Hernia Repair in Children
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Children's Anesthesiology Associates, Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Umbilical Hernia
Keywords
Rectus Sheath, Local infiltration, Pain Control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
Arm Title
2
Arm Type
Active Comparator
Arm Description
2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
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 Measure Information:
Title
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.
Description
total postoperative opioid and any additional analgesic medications.
Time Frame
immediate to 24 hour post-operatively
Secondary Outcome Measure Information:
Title
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.
Description
difference in time to rescue analgesic and the differences in side effects for the two groups.
Time Frame
immediate to 24 hours post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects ages > 5 to < 18 years. American Society of Anesthesiology (ASA)physical status 1 or 2. Patients who undergo an umbilical hernia repair at CHOP. Exclusion Criteria: Parents/patients refusal to the placement of a rectus sheath nerve block. Subjects with allergy to bupivacaine. Patients who are developmentally delayed which precludes their participation in pain scale reporting. Parents who do not comprehend English sufficiently well to read the consent and ask questions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harshad Gurnaney, MBBS
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Analgesic Efficacy After Umbilical Hernia Repair in Children

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