Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine

Not Applicable

Terminated

• Conditions: Inguinal Herniorrhaphy; Orchiopexy
• Interventions: Drug: Ropivacaine

• Registration Number: NCT00616577
• 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 Start: 2007-10
• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-15
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2015-04-02
• Results First Submitted QC: 2015-04-02
• Results First Posted: 2015-04-08
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Age 2 years or younger.
• Weight 33 kg or less.
• Scheduled for elective inguinal herniorrhaphy or orchiopexy.
• American Society of Anesthesiologists Class 1, 2 or 3.

Exclusion Criteria

• Age over 2 years.
• Weight over 33 kg.
• Allergy to ropivacaine.
• Usual contraindications to caudal anesthesia (patient refusal, skeletal or spinal cord anomaly, coagulopathy, infection at insertion site, ongoing bacteremia)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group CB	Ropivacaine	Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.
Group LIA	Ropivacaine	Group LIA (Local Infiltration After-control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.
Group CA	Ropivacaine	Group CA (Caudal After-control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.

Primary Outcome Measures

Name	Time	Method
Usage of Pain Medications	Over 24 hours

Trial Locations

Locations (1)

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