Brachial Plexus Block in Post-Op 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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University Langone Medical Center

New York, 10003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

Post-Operative Pain

Time frame: 2 weeks

post-operative pain will be measured at various time points

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Oct 24, 2013
Registry last updated: Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed