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Clinical Trials/NCT00616577
NCT00616577
Terminated
Not Applicable

Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine: A Prospective, Randomized, Double-blinded, Controlled Study

Loma Linda University1 site in 1 country26 target enrollmentOctober 2007

Overview

Phase
Not Applicable
Intervention
Ropivacaine
Conditions
Inguinal Herniorrhaphy
Sponsor
Loma Linda University
Enrollment
26
Locations
1
Primary Endpoint
Usage of Pain Medications
Status
Terminated
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2007
End Date
September 2010
Last Updated
7 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Arms & Interventions

Group CB

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.

Intervention: Ropivacaine

Group CA

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.

Intervention: Ropivacaine

Group LIA

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.

Intervention: Ropivacaine

Outcomes

Primary Outcomes

Usage of Pain Medications

Time Frame: Over 24 hours

Study Sites (1)

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