Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine

This study has been terminated.
(PI is no longer here.)
Sponsor:
Information provided by (Responsible Party):
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00616577
First received: February 4, 2008
Last updated: June 10, 2014
Last verified: June 2014

February 4, 2008
June 10, 2014
October 2007
September 2010   (final data collection date for primary outcome measure)
Usage of pain medications [ Time Frame: Over 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00616577 on ClinicalTrials.gov Archive Site
  • Pain scores [ Time Frame: At various intervals for first 24 hours ] [ Designated as safety issue: No ]
  • Time to first dose of pain medication following surgery [ Time Frame: Within first 24hours following surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine
Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine: A Prospective, Randomized, Double-blinded, Controlled Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Inguinal Herniorrhaphy.
  • Orchiopexy.
  • Drug: Ropivacaine
    caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine
  • Drug: Ropivacaine
    local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site
  • Experimental: Group CB
    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.
    Intervention: Drug: Ropivacaine
  • Active Comparator: Group CA
    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.
    Intervention: Drug: Ropivacaine
  • Active Comparator: Group LIA
    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.
    Intervention: Drug: Ropivacaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
26
September 2010
September 2010   (final data collection date for primary outcome measure)

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)
Both
up to 2 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00616577
57235
No
Loma Linda University
Loma Linda University
Not Provided
Principal Investigator: Charles Lee, M.D. Loma Linda University Medical Center
Loma Linda University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP