Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine

NCT00616577 | Terminated Results

• 1 other identifier: 57235
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 Herniorrhaphy; Orchiopexy

Keywords

Caudal Epidural Ropivacaine

Outcome Measures

Primary Outcomes (1)

• Usage of Pain Medications

  Over 24 hours

Study Arms (3)

Group CB

EXPERIMENTAL

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.

Drug: Ropivacaine

Group CA

ACTIVE COMPARATOR

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.

Drug: Ropivacaine

Group LIA

ACTIVE COMPARATOR

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.

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine

Group CB

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Charles Lee, MD
• Organization: Loma Linda University

thamilton@llu.edu

909-558-9408

Study Officials

• Charles Lee, M.D.

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 15, 2008
• Study Start: October 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 25, 2019
• Results First Posted: April 8, 2015

Record last verified: 2019-04

Locations

US (1)