Caudal Versus Rectus Sheath Study

Nationwide Children's Hospital

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Umbilical Hernia

Treatments: Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01394523

IRB11-00363

Details and patient eligibility

About

The literature has clearly demonstrated that the effective treatment of postoperative pain in infants and children is challenging. In an effort to improve postoperative analgesia while limiting opioid-related adverse effects, there continues to be an increased use of regional anesthetic techniques in infants and children. Although the pediatric caudal remains the most commonly used pediatric regional anesthetic technique, it has been demonstrated that effective analgesia can be provided with the use of peripheral nerve blockade even in the pediatric-aged patient. The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing umbilical hernia repair who have received either a caudal block or bilateral rectus sheath blocks for analgesia

Enrollment: 39 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA physical status I or II
• Weight less than or equal to 20 kg
• Presenting for repair of umbilical hernia

Exclusion criteria

• ASA physical status > II
• Weight greater than 20 kg
• Co-morbid diseases (cardiac, pulmonary, neurological disease)
• Patients having concomitant procedures (circumcision, orchiopexy, etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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39 participants in 3 patient groups

Caudal epidural

Active Comparator group

Description:

The caudal epidural block will be delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.

Treatment:

Drug: Bupivacaine

Rectus sheath

Active Comparator group

Description:

The rectus sheath block will be performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance.

Treatment:

Drug: Bupivacaine

Local

Active Comparator group

Description:

The surgeon will inject either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.

Treatment:

Drug: Bupivacaine