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Multimodal Pain Management for Postoperative Pain
Phase 4
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Orthopaedic injury requiring surgery
Age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial seeks to reduce opioid usage in orthopaedic surgery patients by testing a new pain management protocol.
Who is the study for?
Adults aged 18+ who need orthopaedic surgery at UCSD and can consent to participate are eligible. Excluded are those with multiple injuries, severe diseases not managed medically, pregnant women or those planning pregnancy within a year, prisoners, recent substance abusers, and anyone in another drug study recently.Check my eligibility
What is being tested?
The trial compares two pain management methods after orthopaedic surgery: a multimodal approach using Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine versus standard oral hydrocodone-acetaminophen. It's randomized and will assess opioid use, pain control, and function.See study design
What are the potential side effects?
Possible side effects include stomach issues from Ibuprofen/Acetaminophen; dizziness or fatigue from GABAPentin; local numbness from Bupivacaine; and constipation or drowsiness from hydrocodone-acetaminophen.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need surgery for a bone or joint injury.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Morphine equivalents used
Secondary outcome measures
Number of Complications
Pain Score (0-10, 0=no pain, 10=most severe pain)
Trial Design
2Treatment groups
Active Control
Group I: Standard oral hydrocodone-acetaminophen post-op managementActive Control1 Intervention
Group II: Multimodal pain post-op management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)Active Control1 Intervention
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,307 Total Patients Enrolled
6 Trials studying Postoperative Pain
401 Patients Enrolled for Postoperative Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chosen a specific way to manage my pain.I need surgery for a bone or joint injury.Severe injuries from multiple traumas.I do not have any severe illnesses that are not under control.The doctor will decide how to manage your pain during the study.I am 18 years old or older.You have been using drugs or drinking alcohol recently, which could affect how we measure your pain or control it.
Research Study Groups:
This trial has the following groups:- Group 1: Standard oral hydrocodone-acetaminophen post-op management
- Group 2: Multimodal pain post-op management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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 currently open?
"According to clinicialtrials.gov, this clinical trial is actively enrolling participants. The first posting of the study was on May 17th 2021 and it has been recently edited as of January 9th 2023."
Answered by AI
How many individuals have enrolled in the experiment thus far?
"Affirmative. Clinicaltrials.gov confirms that this investigation, initially posted on May 17th 2021, is currently recruiting patients. The aim is to recruit a total of 100 individuals from 1 distinct site for the trial's duration."
Answered by AI
What potential risks should be considered with the implementation of a combined Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine medication regimen for post-operative pain management?
"There is ample evidence demonstrating the safety of this post-operative pain management system, so it was awarded a score of 3."
Answered by AI
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