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

NCT02056288 | Terminated Phase 4 Results DMC

• 1 other identifier: H-27386
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Supracondylar Fractures

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  Opioid administration measured in mg/kg. Results below represent the total opioids given in the PACU, after discharge from the PACU, and then total post-operative period.

  up to 48 hours after surgery

Secondary Outcomes (5)

• Time of First Analgesia Request

  PACU Period up to 3 hours

• Time of Achieving Discharge Readiness

  From the time of PACU arrival up to time the patient achieves an Aldrete Score of 9- 10.

• Incidence of Side Effects

  up to 48 hours after surgery

• Patient and Parent Satisfaction

  up to 48 hours after surgery

• The Mean Pain Score in the Postoperative Period

  From admission to PACU to 48 hours after surgery

Study Arms (2)

Ultrasound Guided Supraclavicular block

ACTIVE COMPARATOR

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

IV Opioids

ACTIVE COMPARATOR

Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.

Drug: Fentanyl

Interventions

Fentanyl DRUG

Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.

IV Opioids

Ropivacaine DRUG

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).

Ultrasound Guided Supraclavicular block

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \) 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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children't Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Fentanyl; Ropivacaine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Chris D. Glover, MD, MBA, Principal Investigator
• Organization: Baylor College of Medicine

cdglover@texaschildrens.org

832-824-5800

Study Officials

• Chris Glover, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Melissa Challman, MPH

  Baylor College of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Perioperative Services

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 5, 2014
• Study Start: March 10, 2011
• Primary Completion: February 11, 2019
• Study Completion: March 1, 2019
• Last Updated: May 21, 2021
• Results First Posted: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)