A Comparison of UGSB and GA to IV Narcotics and GA for Post-Op Pain in Children With Supracondylar Fractures.

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Baylor College of Medicine
Sponsor:
Information provided by (Responsible Party):
Chris Glover, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT02056288
First received: February 4, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

This study compares nerve blocks to IV pain medicines in children with broken arms. We are trying to see if blocking the nerves in the broken arm results in better pain control and less side effects than injections of morphine into a vein after surgery for a broken elbow.


Condition Intervention Phase
Supracondylar Fractures
Drug: Fentanyl
Drug: Ropivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Ultrasound Guided Supraclavicular Block(UGSB) and General Anesthesia (GA) to IV Narcotics and General Anesthesia for Postoperative Pain Relief in Children With Supracondylar Fractures.

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • The primary endpoint of the study will be the peak or maximum pain score in the postoperative period [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]
    verbal rating scale where 0 = no pain and 10 = worst possible pain ever


Estimated Enrollment: 80
Study Start Date: March 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ultrasound guided supraclavicular block
Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml), using the technique described by Marhofer et al. In order to decrease variance in success rates, the ultrasound guided nerve block will be performed by 1 of the 4 anesthesiology co-investigators, each of whom have successfully performed over 100 ultrasound guided blocks in the past. Supraclavicular blocks were performed using the higher frequency of the probe and placing it in a coronal-oblique-plane in the supraclavicular fossa.
Drug: Ropivacaine
Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml).
Other Name: Ropivacaine
Active Comparator: IV Opiods
Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
Drug: Fentanyl
Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
Other Name: Fentanyl

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1) Supracondylar fracture (2) Age 2-17 years (3) American Society of Anesthesiologists Status 1 -3 (4) Scheduled for closed reduction with percutaneous pinning under general anesthesia

Exclusion Criteria:

  1. Pulseless extremity
  2. Compromised neurologic status on exam (specifically assessment of radial, ulnar, and median nerve)
  3. Known allergy to local anesthetics (7) Not scheduled for closed reduction with percutaneous pinning under general anesthesia
  4. Bleeding diathesis
  5. American Society of Anesthesiologist (ASA) status 4 or higher.
  6. Sleep apnea by polysomnography
  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: NCT02056288

Contacts
Contact: Samantha Capehart, RN 832-824-5913 capehart@bcm.edu
Contact: Chris Glover, MD 832-824-5800 cdglover@bcm.edu

Locations
United States, Texas
Texas Children't Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Chris Glover, MD    832-824-5800    cdglover@bcm.edu   
Principal Investigator: Chris Glover, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Chris Glover, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Chris Glover, assistant professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02056288     History of Changes
Other Study ID Numbers: H-27386
Study First Received: February 4, 2014
Last Updated: February 4, 2014
Health Authority: United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Fentanyl
Narcotics
Ropivacaine
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local

ClinicalTrials.gov processed this record on August 18, 2014