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Opiate Sparing Protocol for Wrist Fractures

N/A
Waitlist Available
Led By William J Weller, MD
Research Sponsored by Campbell Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Open reduction internal fixation surgery at Campbell Clinic Surgery Center
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six week to twelve week visit
Awards & highlights

Study Summary

This trial looks at whether using less opiate medication results in less pain for people who have just had surgery to fix a broken bone in their wrist.

Who is the study for?
This trial is for individuals needing surgery for a broken wrist, specifically an open distal radius fracture. Participants must speak and read English well and have a BMI of 45 or less. It's not for those on certain blood pressure meds, with kidney disease, under worker's comp, pregnant/breastfeeding women, recent opioid users, known drug sensitivities, or with other upper limb issues.Check my eligibility
What is being tested?
The study compares two pain management strategies after wrist fracture surgery: one that tries to minimize the use of opiates (like morphine) and another that uses standard opiate-based treatment. The goal is to see which group needs fewer oral morphine equivalents post-surgery.See study design
What are the potential side effects?
Opiate-based treatments can lead to side effects like nausea, constipation, drowsiness or addiction risks. Opiate sparing approaches may involve non-opioid medications which could also cause various reactions depending on the drugs used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had surgery to fix broken bones at Campbell Clinic.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six week to twelve week visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and six week to twelve week visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Morphine
Secondary outcome measures
Visual Analog Score
Other outcome measures
Incidence of treatment-emergent adverse event
Patient satisfaction Score

Side effects data

From 2013 Phase 3 trial • 653 Patients • NCT00316277
33%
Headache
14%
Nausea
13%
Constipation
12%
Insomnia
9%
Anxiety
8%
Vomiting
6%
Nasopharyngitis
6%
Toothache
5%
Fatigue
5%
Back Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Buprenorphine/Nx With EMM
Buprenorphine/Nx With SMM

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Opiate SparingExperimental Treatment1 Intervention
Standard icing and elevation therapy Acetaminophen 1000 milligrams by mouth every 8 hours for five days then as needed every 8 hours for pain control Gabapentin 100 milligrams by mouth three times per day for 14 days Celecoxib 100 milligrams by mouth two times per day for 5 days Esomeprazole 20 milligrams by mouth once per day for 14 days Promethazine 12.5 milligrams by mouth every 8 hours as needed for nausea or vomiting Docusate 100 milligrams by mouth two times per day while taking oxycodone Oxycodone 5 milligrams by mouth every 6 hours as needed for pain control unresponsive to other medications
Group II: Opiate BasedActive Control1 Intervention
Standard icing and elevation therapy Oxycodone 5-10 milligrams by mouth every 4 to 6 hours as needed for pain control Acetaminophen 1000 milligrams by mouth every 8 hours as needed for pain control Promethazine 12.5 milligrams by mouth every 8 hours as needed for nausea or vomiting Docusate 100 milligrams by mouth two times per day while taking oxycodone

Find a Location

Who is running the clinical trial?

Campbell ClinicLead Sponsor
10 Previous Clinical Trials
1,750 Total Patients Enrolled
William J Weller, MDPrincipal InvestigatorCampbell Clinic

Media Library

Opiate Based Clinical Trial Eligibility Overview. Trial Name: NCT05215236 — N/A
Distal Radius Fracture Research Study Groups: Opiate Sparing, Opiate Based
Distal Radius Fracture Clinical Trial 2023: Opiate Based Highlights & Side Effects. Trial Name: NCT05215236 — N/A
Opiate Based 2023 Treatment Timeline for Medical Study. Trial Name: NCT05215236 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open opportunities for individuals to join this clinical examination?

"This investigation, as displayed on clinicaltrials.gov, is not presently enrolling patients; the trial was first posted on March 1st 2022 and last edited June 28th 2022. Despite this study no longer recruiting, 353 other medical experiments are currently seeking participants to take part in their research."

Answered by AI

Am I eligible to join the experiment?

"In order to take part in this clinical trial, applicants must have sustained a fracture and be between 18-85 years of age. A total of 72 patients will ultimately join the research."

Answered by AI

Is the recruitment process inclusive of individuals aged 45 and over?

"This clinical trial is accepting applicants who are aged 18 and above, but no older than 85."

Answered by AI
Recent research and studies
~20 spots leftby Dec 2024