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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours, 48 hours, 72 hours postop
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I need surgery for a broken bone that is the only injury.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain 24 hours
Secondary outcome measures
Nausea and Vomiting 24 hours
Pain 12 hours
Pain 48 hours
+2 moreOther outcome measures
Analgesic consumption
Rebound pain
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.
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Who is running the clinical trial?
MaineGeneral HealthLead Sponsor
1 Previous Clinical Trials
39 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently hospitalized.My injury happened less than 2 weeks ago.I have had multiple broken bones.I need surgery for a broken bone that is the only injury.I have difficulty with memory or thinking clearly.I am not currently hospitalized.I cannot have a peripheral nerve block due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Peripheral Nerve Block
- Group 2: General Anesthesia +/- PNB
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this trial open to individuals?
"Per information available on clinicaltrials.gov, this trial is looking for patients to participate. It was first posted to the website on May 16th 2022 and has been edited most recently as of May 24th 2022."
Answered by AI
How many study participants are being accepted into this clinical research?
"Affirmative. Clinicaltrials.gov provides confirmation that this research venture, which was initially made public on May 16th 2022, is currently in need of participants. A total of 160 individuals have to be sourced from 1 medical facility."
Answered by AI
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