Caudal Versus Rectus Sheath Study

Phase 3TerminatedNCT01394523

Nationwide Children's Hospital39 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Umbilical Hernia

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.)

Outcomes

Primary Outcomes

Post-operative Pain Score

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.

Time frame: 30 minutes