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Preoperative Education for Wrist Fractures
N/A
Waitlist Available
Led By Paul Ghareeb, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, postoperative day 0-3, postoperative day 4-7, postoperative day 8-10
Awards & highlights
Study Summary
This trial will compare how much pain medication patients use after surgery when they get standardized education about pain before surgery.
Who is the study for?
Adults over 18 with a closed distal radius fracture needing outpatient surgery at Grady Memorial Hospital can join. They must be mentally capable of consent, speak English or Spanish, and agree to use NSAIDs post-surgery. Excluded are pregnant women, prisoners, those with cognitive impairments, inpatients, open fractures or other injuries on the same limb.Check my eligibility
What is being tested?
The trial is testing if standardized preoperative education reduces opioid use after wrist fracture surgery compared to standard care. Patients will receive either an educational session or usual instructions before their operation and fill out questionnaires before and after surgery.See study design
What are the potential side effects?
There may not be direct side effects from participating in this study since it involves education rather than medication; however, typical surgical risks apply such as pain, infection risk at the surgical site, bleeding complications or reactions to anesthesia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ postoperative (up to 2 weeks after surgery)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative (up to 2 weeks after surgery)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in total oral morphine equivalents consumed from day of surgery to postoperative day 10
Secondary outcome measures
Change in average daily VAS pain scores for early (postoperative day 0-3), middle (postoperative day 4-7), and late (postoperative day 8-10) postoperative period between the two study arms
Change in results of Pain Management quiz after education
Percentage of participants with adequate postoperative pain control
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental ArmExperimental Treatment2 Interventions
Patients in the experimental arm will receive standardized preoperative education in the form of a brief video, interactive quiz, and written handout.
All patients will receive standardized multimodal pain management consisting of a long-acting peripheral nerve block, scheduled non-opioid pain medications, an opioid prescription to be taken only as needed, and adjunctive medicines to be taken as needed for any side effects.
Group II: Control ArmActive Control2 Interventions
Patients in the control arm will receive education per the provider's preference (current standard of care).
All patients will receive standardized multimodal pain management consisting of a long-acting peripheral nerve block, scheduled non-opioid pain medications, an opioid prescription to be taken only as needed, and adjunctive medicines to be taken as needed for any side effects.
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Who is running the clinical trial?
American Society for Surgery of the HandOTHER
10 Previous Clinical Trials
1,076 Total Patients Enrolled
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,568 Total Patients Enrolled
Paul Ghareeb, MDPrincipal InvestigatorEmory University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot handle or tolerate non-steroidal anti-inflammatory drugs (NSAIDs).The surgery will use either a volar locking plate or a dorsal spanning plate, which are specific types of surgical techniques.You have other injuries on the same arm as the broken wrist.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm
- Group 2: Control Arm
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.
How many individuals have been enrolled in this medical trial thus far?
"That is accurate. Information from clinicaltrials.gov states that this medical research project, which was first made public on March 15th 2022, requires additional participants. 60 volunteers are needed at a single location for the experiment to commence."
Answered by AI
Are recruitment efforts currently underway for this research project?
"According to clinicaltrials.gov, this medical research is still recruiting participants. It was initially created on March 15th 2022 and had its most recent update on the 24th of that month."
Answered by AI
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