Analgesia in Children Using Caudal Epidural Ropivacaine

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shannon Mulder, MD, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01494272
First received: December 15, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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
Inguinal Hernia
Circumcision

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine: A Prospective, Randomized, Double-blinded, Controlled Study

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Usage of pain medications [ Time Frame: over 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain scores [ Time Frame: At various intervals for first 24 hours ] [ Designated as safety issue: No ]
  • Pain Scores [ Time Frame: At various intervals for first 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group CB (Caudal Before-study group)
This group will receive caudal ropivacaine and epinephrine after induction of general anesthesia prior to surgical incision
Caudal After (CA)-control group
This group will receive caudal ropivacaine with epinephrine after completion of surgery but before emergence from anesthesia
Local Infiltration After (LIA) control group
This group will receive local infiltration of ropivacaine around the surgery site at the conclusion of surgery but before emergence from anesthesia

  Eligibility

Ages Eligible for Study:   2 Months to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Children under 2 years of age having an elective inguinal herniorrhaphy or orchiopexy.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494272

Locations
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Loma Linda University Outpatient Surgery Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Shannon Mulder, MD Loma Linda University Medical Center
  More Information

No publications provided

Responsible Party: Shannon Mulder, MD, M.D., Loma Linda University
ClinicalTrials.gov Identifier: NCT01494272     History of Changes
Other Study ID Numbers: 5110235
Study First Received: December 15, 2011
Last Updated: July 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
caudal epidural analgesia
elective circumcision
elective inguinal herniorrhaphy

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014