Analgesia in Children Using Caudal Epidural Ropivacaine

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

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

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia; Circumcision

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Loma Linda, California, United States, 92354
      • Loma Linda University Outpatient Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children under 2 years of age having an elective inguinal herniorrhaphy or orchiopexy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group CB (Caudal Before-study group); This group will receive caudal ropivacaine and epinephrine after induction of general anesthesia prior to surgical incision
Caudal After (CA)-control group; This group will receive caudal ropivacaine with epinephrine after completion of surgery but before emergence from anesthesia
Local Infiltration After (LIA) control group; This group will receive local infiltration of ropivacaine around the surgery site at the conclusion of surgery but before emergence from anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Usage of pain medications	over 24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain scores	At various intervals for first 24 hours

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Shannon Mulder, MD, Loma Linda University Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: December 15, 2011
• First Posted (Estimate): December 16, 2011

Study Record Updates

• Last Update Posted (Estimate): November 25, 2015
• Last Update Submitted That Met QC Criteria: November 23, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: caudal epidural analgesia; elective circumcision; elective inguinal herniorrhaphy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: 5110235