Analgesia in Children Using Caudal Epidural Ropivacaine

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494272
• Other study ID #: 5110235
• Status: Completed
• Phase: N/A
• First received: December 15, 2011
• Last updated: November 23, 2015
• Start date: June 2012
• Est. completion date: May 2015

Study information

• Verified date: November 2015
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 2 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Circumcision
• Hernia, Inguinal
• Inguinal Hernia

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Loma Linda University Outpatient Surgery Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usage of pain medications		over 24 hours	No
Secondary	Pain scores		At various intervals for first 24 hours	No