Analgesia in Children Using Caudal Epidural Ropivacaine

Completed

• Conditions: Inguinal Hernia; Circumcision

• Registration Number: NCT01494272
• Lead Sponsor: Loma Linda University

Brief Summary

Caudal epidural analgesia (caudal block)is used in standard pediatric anesthesia practice. It has been shown to be effective in managing postoperative pain in children undergoing abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown that children receiving caudal blocks have secondary benefits such as lower narcotic and anesthetic requirements, more rapid awakening from general anesthesia, decreased time to discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias et al 1995, Tobias 1996).

This proposed study involves the use of a caudal block in children undergoing elective inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with a caudal block before the onset of a painful stimulus, we can decrease central nervous system sensitization and reduce postoperative analgesic requirements

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-16
• Study Start: 2012-06
• Primary Completion: 2014-04
• Study Completion: 2015-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-23
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Age 2 months to 2 years
2. Weight 25kg or less
3. ASA class 1, 2, 3
4. Elective inguinal herniorrhaphy or orchiopexy

Exclusion Criteria

1. Contraindications to caudal epidural analgesia
2. parent's refusal
3. skeletal or spinal cord anomaly
4. coagulopathy
5. infection at the insertion site
6. ongoing bacteremia
7. allergy to ropivacaine

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Usage of pain medications	over 24 hours

Secondary Outcome Measures

Name	Time	Method
Pain scores	At various intervals for first 24 hours

Trial Locations

Locations (2)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Loma Linda University Outpatient Surgery Center; 🇺🇸 Loma Linda, California, United States