Caudal Versus Rectus Sheath Study

Phase 2

Terminated

• Conditions: Umbilical Hernia
• Interventions: Drug: Bupivacaine

• Registration Number: NCT01394523
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Study Start: 2011-08
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-11
• Results First Submitted: 2017-11-21
• Results First Submitted QC: 2017-11-21
• Last Update Submitted: 2017-11-21
• Results First Posted: 2017-12-19
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caudal epidural	Bupivacaine	The caudal epidural block will be delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.
Rectus sheath	Bupivacaine	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.
Local	Bupivacaine	The surgeon will inject either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.

Primary Outcome Measures

Name	Time	Method
Post-operative Pain Score	30 minutes	Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States