Caudal Versus Rectus Sheath Study

Umbilical Hernia Clinical Trial

Official title:

A Prospective, Double-blinded, Randomized Comparison of Caudal Analgesia Versus Ultrasound Guided Rectus Sheath Blocks for Umbilical Herniorrhaphy in the Pediatric Population

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01394523
• Other study ID #: IRB11-00363
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: July 11, 2011
• Last updated: November 21, 2017
• Start date: August 2011
• Est. completion date: September 2016

Study information

• Verified date: November 2017
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.)

Related Conditions & MeSH terms

• Hernia, Umbilical
• Umbilical Hernia

Intervention

Drug:
• Bupivacaine
0.25% or 0.5%

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 minutes