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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
Must not have
Any not medically managed severe systemic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

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.
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.
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 below
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I need surgery for a bone or joint injury.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses that are not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Morphine equivalents used

Awards & Highlights

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.

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

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,189 Previous Clinical Trials
1,587,641 Total Patients Enrolled
14 Trials studying Pain
689 Patients Enrolled for Pain

Media Library

Multimodal Pain Management (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05690282 — Phase 4
Pain Research Study Groups: Standard oral hydrocodone-acetaminophen post-op management, Multimodal pain post-op management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)
Pain Clinical Trial 2023: Multimodal Pain Management Highlights & Side Effects. Trial Name: NCT05690282 — Phase 4
Multimodal Pain Management (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05690282 — Phase 4
~22 spots leftby Dec 2025
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