Analgesic Efficacy After Umbilical Hernia Repair in Children

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Umbilical Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

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.

2

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No