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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Plexus Brachialis Block. Better to do by Start Than by End of Surgery?

NCT01740141

Pain

COMPLETED NA

Prospective Clinical Trial Comparing Infraclavicular Versus Axillary Approach to Brachial Plexus Block

NCT02208245

Scaphoid Fractures Distal Radius Fractures Wrist Injury Arthrodesis

UNKNOWN NA

US-Guided Preemptive Brachial Plexus Blockade May Reduce Post-operative Pain: a Randomized Study

NCT04005534

Postoperative Pain Rotator Cuff Injuries

COMPLETED NA

Single Shot vs Catheter Infraclavicular Brachial Plexus Block After Distal Radius Fracture Repair

NCT02744352

Distal Radius Fracture Post Operative Pain Control

TERMINATED NA

Nerve Block for Pain Control After Fracture Surgery

NCT05391464

Ankle Fractures Distal Radius Fracture

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

General Anesthesia

general anesthesia only

Group Type NO_INTERVENTION

No interventions assigned to this group

Brachial Plexus Nerve Block

brachial plexus nerve block

Group Type EXPERIMENTAL

Brachial Plexus Nerve Block

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes