Brachial Plexus Block in Post-Op Pain Control After Distal Upper Extremity Fracture: A Prospective Randomized Study

NCT01968824 | Completed DMC

• 1 other identifier: S12-02386
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the plethora of literature suggesting that regional blockade provides adequate andimproved postoperative pain control, function and improved intraoperative and postoperative safety in proximal upper extremity surgery, little is known of its benefits for the treatment of forearm and distal radius fractures . The purpose of this randomized, prospective, study is to determine if brachial plexus blockade with general anesthesia is superior to general anesthesia alone in immediate and long-term pain control in patients undergoing operative fixation of distal upper extremity fractures.

Conditions

Pain

Keywords

pain

Outcome Measures

Primary Outcomes (1)

• Post-Operative Pain

  post-operative pain will be measured at various time points

  2 weeks

Study Arms (2)

General Anesthesia

NO INTERVENTION

general anesthesia only

Brachial Plexus Nerve Block

EXPERIMENTAL

brachial plexus nerve block

Procedure: Brachial Plexus Nerve Block

Interventions

Brachial Plexus Nerve Block PROCEDURE

The brachial plexus will be visualized under ultrasound and a 22 gauge, 3.5 inch needle will be used. 20 cc of bupivicaine will be injected around the brachial plexus after confirming negative aspiration every 5 cc

Brachial Plexus Nerve Block

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at least 18 years old.
• Male or Female
• All racial and ethnic groups
• Fractures and fracture/dislocations of the elbow, forearm, wrist and hand
• Montaggia and Galleazzi variants
• Patients who opt for surgical treatment of their fractures.
• Patients who consent to be randomized.
• Patients who are willing to follow-up for a minimum of 52 weeks.

You may not qualify if:

• Patients younger than 18 years old.
• Patients who are unwilling to follow-up for a minimum of 52 weeks.
• Limitation in upper extremity function that would affect outcome scoring
• Neurologic condition that could interfere with pain sensation
• Patients with a contraindication to one of the anesthesia protocols
• Patients who refuse a specific anesthesia protocol

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nirmal C Tejwani, MD

  NYU Hospital for Joint Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 24, 2013
• Study Start: January 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

US (1)