Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine

Inguinal Herniorrhaphy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00616577
• Other study ID #: 57235
• Status: Terminated
• Phase: N/A
• Start date: October 2007
• Est. completion date: September 2010

Study information

• Verified date: April 2019
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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: Terminated
• Enrollment: 26
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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)

Related Conditions & MeSH terms

• Inguinal Herniorrhaphy
• Orchiopexy

Intervention

Drug:
• Ropivacaine
caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine
• Ropivacaine
caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine
• Ropivacaine
local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site

Locations

Country	Name	City	State
United States	Loma Linda University Medical 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