A Prospective, Double-blinded, Randomized Comparison of Caudal Analgesia Versus Ultrasound Guided Rectus Sheath Blocks for Umbilical Herniorrhaphy in the Pediatric Population
Overview
- Phase
- Phase 2
- Intervention
- Bupivacaine
- Conditions
- Umbilical Hernia
- Sponsor
- Nationwide Children's Hospital
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Post-operative Pain Score
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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
Investigators
Tarun Bhalla, MD
Attending Anesthesiologist
Nationwide Children's Hospital
Eligibility Criteria
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.)
Arms & Interventions
Caudal epidural
The caudal epidural block will be delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.
Intervention: Bupivacaine
Rectus sheath
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.
Intervention: Bupivacaine
Local
The surgeon will inject either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.
Intervention: Bupivacaine
Outcomes
Primary Outcomes
Post-operative Pain Score
Time Frame: 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.