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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Procedure: Brachial Plexus Nerve Block

Detailed Description

The purpose of this study is to compare two (2) different types of anesthesia treatments that are used during surgery for broken arms for post-surgery pain relief. One group will receive general anesthesia (state of total unconsciousness) the other group will get sedation (medicine injected into patient's vein that helps patient fall asleep), and a nerve block (injection of anesthetic drug into the nerves going to patient's arm in order to make patient's arm numb).

Both forms of anesthesia are used for a variety of surgeries to the arm including shoulder and elbow surgeries. Currently it is thought that there are advantages and disadvantages to both types. The advantage of not using the nerve block in addition to general anesthesia (current standard or care) is that it decreases the potential risk for bleeding, infection and nerve injury. Alternatively, the advantage of using the nerve block with sedation (research-related procedure) is that it can potentially offer better post-operative pain control. This study will examine whether there is added benefit with the addition of nerve block for anesthesia for decreasing pain after surgical treatment of lower arm fractures.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • New York University Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: General Anesthesia; general anesthesia only
Experimental: Brachial Plexus Nerve Block; brachial plexus nerve block	Procedure: Brachial Plexus Nerve Block; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Operative Pain	post-operative pain will be measured at various time points	2 weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Nirmal C Tejwani, MD, NYU Hospital for Joint Diseases

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: October 14, 2013
• First Submitted That Met QC Criteria: October 18, 2013
• First Posted (Estimate): October 24, 2013

Study Record Updates

• Last Update Posted (Estimate): January 23, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: pain
• Other Study ID Numbers: S12-02386