Analgesia in Children Using Caudal Epidural Ropivacaine

NCT01494272 | Completed

• 1 other identifier: 5110235
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

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

Conditions

Inguinal Hernia; Circumcision

Keywords

caudal epidural analgesia; elective circumcision; elective inguinal herniorrhaphy

Outcome Measures

Primary Outcomes (1)

• Usage of pain medications

  over 24 hours

Secondary Outcomes (1)

• Pain scores

  At various intervals for first 24 hours

Study Arms (3)

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

Eligibility Criteria

• Age: 2 Months - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Contraindications to caudal epidural analgesia
• parent's refusal
• skeletal or spinal cord anomaly
• coagulopathy
• infection at the insertion site
• ongoing bacteremia
• allergy to ropivacaine

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (2)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Loma Linda University Outpatient Surgery Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Shannon Mulder, MD

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 16, 2011
• Study Start: June 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2015
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

US (2)