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

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: NCT02056288
Recruitment Status : Active, not recruiting
First Posted : February 5, 2014
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Chris Glover, Baylor College of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Supracondylar Fractures Drug: Fentanyl Drug: Ropivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Actual Study Start Date : March 10, 2011
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
Drug Information available for: Fentanyl

Arm Intervention/treatment
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).

Active Comparator: IV Opioids
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.




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


Secondary Outcome Measures :
  1. Opioid consumption [ Time Frame: up to 48 hours after surgery ]
    Opioid administration measured in morphine equivalents

  2. Time of first analgesia request [ Time Frame: up to 48 hours after surgery ]
    Time at which additional analgesia was requested and/or administered by the nurse while inpatient or parents following discharge

  3. Time of achieving discharge readiness [ Time Frame: Up to 48 hours after surgery. From the time of PACU arrival up to time the patient achieves an Aldrete Score of 9- 10. ]
    Documented time that patient achieves and Aldrete Score of 9 -10. This is a standardized scale used to assess discharge readiness at Texas Children's Hospital.

  4. Incidence of side effects [ Time Frame: up to 48 hours after surgery ]
    Documented side effects such as vomiting, respiratory depression, itching, dysphoria, compartment syndrome

  5. Patient and Parent satisfaction [ Time Frame: up to 48 hours after surgery ]
    Patient and Parent satisfaction with pain management as well as the global perioperative experience graded on a numeric scale of 0 - 10, with 0 indicating poor management to 10 indicating excellent pain management.



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

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): NCT02056288


Locations
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United States, Texas
Texas Children't Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Chris Glover, MD Baylor College of Medicine

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Responsible Party: Chris Glover, Medical Director of Perioperative Services, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02056288    
Other Study ID Numbers: H-27386
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries
Fentanyl
Narcotics
Ropivacaine
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local