Analgesic Efficacy After Umbilical Hernia Repair in Children

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Umbilical Hernia

Treatments: Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00578136

2006-10-4980

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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52 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine

2

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine