ClinicalTrials.gov
ClinicalTrials.gov Menu

Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00616577
Recruitment Status : Terminated (PI is no longer here.)
First Posted : February 15, 2008
Results First Posted : April 8, 2015
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

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.


Condition or disease Intervention/treatment Phase
Inguinal Herniorrhaphy Orchiopexy Drug: Ropivacaine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine: A Prospective, Randomized, Double-blinded, Controlled Study
Study Start Date : October 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Usage of Pain Medications [ Time Frame: Over 24 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616577


Locations
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Charles Lee, M.D. Loma Linda University Medical Center

Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT00616577     History of Changes
Other Study ID Numbers: 57235
First Posted: February 15, 2008    Key Record Dates
Results First Posted: April 8, 2015
Last Update Posted: February 7, 2017
Last Verified: December 2016

Keywords provided by Loma Linda University:
Caudal Epidural Ropivacaine

Additional relevant MeSH terms:
Ropivacaine
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents