Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine
Information source: Loma Linda University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Inguinal Herniorrhaphy.; Orchiopexy.
Intervention: Ropivacaine (Drug); Ropivacaine (Drug); Ropivacaine (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Loma Linda University Official(s) and/or principal investigator(s): Charles Lee, M.D., Principal Investigator, Affiliation: Loma Linda University Medical Center
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.
Clinical Details
Official title: Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine: A Prospective, Randomized, Double-blinded, Controlled Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: Usage of Pain Medications
Eligibility
Minimum age: N/A.
Maximum age: 2 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Loma Linda University Medical Center, Loma Linda, California 92354, United States
Additional Information
Starting date: October 2007
Last updated: April 2, 2015
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