← Back to Search

Nerve Block for Pain Control After Broken Bone Surgery

N/A

Recruiting

Research Sponsored by MaineGeneral Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Isolated fracture requiring surgery

Be older than 18 years old

Must not have

Inpatients

Multiple fractures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours, 48 hours, 72 hours postop

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether it's better to have surgery for a broken ankle or radius while under general anesthesia or peripheral nerve block with sedation.

Who is the study for?

This trial is for outpatients with a recent (within 2 weeks) isolated ankle or distal radius fracture needing surgery. Participants must be able to follow-up via telephone and have no cognitive impairments, multiple fractures, inpatient status, or contraindications to nerve blocks.

What is being tested?

The study compares pain relief strategies after fracture surgery: one group receives peripheral nerve block with sedation during surgery, while the other gets general anesthesia followed by a nerve block only if needed for pain after surgery.

What are the potential side effects?

Peripheral nerve blocks may cause side effects like discomfort at the injection site, weakness or numbness lasting longer than expected, infection risk at the injection area, and rarely more serious complications such as nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need surgery for a broken bone that is the only injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently hospitalized.

Select...

I have had multiple broken bones.

Select...

I have difficulty with memory or thinking clearly.

Select...

I cannot have a peripheral nerve block due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours, 48 hours, 72 hours postop

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours, 48 hours, 72 hours postop

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours, 48 hours, 72 hours postop for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain 24 hours

Secondary study objectives

Nausea and Vomiting 24 hours

Pain 12 hours

Pain 48 hours

+2 more

Other study objectives

Analgesic consumption

Rebound pain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Peripheral Nerve BlockActive Control1 Intervention

Participants will receive an ultrasound-guided, single shot PNB using 30ml 0.5% bupivacaine with 10mg dexamethasone. The anatomic location of the block will be determined by the anesthesiologist and will vary according to fracture location and anticipated surgical approaches. Intraoperative sedation will be used at the discretion of the anesthetic team.

Group II: General Anesthesia +/- PNBActive Control1 Intervention

GA will be administered in the operating room by a nurse anesthetist, with support from the anesthesiologist. GA will be induced with propofol and fentanyl and maintained with sevoflurane or desflurane and fentanyl. Doses will be determined by the anesthesiology team.

0 / 5Eligibility criteria met