Multimodal Pain Management for Postoperative Pain

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an orthopaedic injury requiring surgery. Patients who consent to study participation will be randomized to receive either the multimodal pain management protocol or standard oral hydrocodone-acetaminophen for post-operative pain management. Data on opioid usage, pain control, and functional status will be collected for each participant. After 3 years of data collection, investigators will analyze this data to provide further insight in determining appropriateness of pain regimens that reduce the overall opioid consumption. Given the widespread opioid epidemic, it is imperative to develop alternative means to appropriately manage pain in orthopaedic surgery patients.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

Evaluation and treatment at UCSD

I need surgery for a bone or joint injury.

Ability to understand the content of the patient information/Informed Consent Form

Exclusion Criteria

I have chosen a specific way to manage my pain.

Prisoner

Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study

Treatment Details

Interventions

• Multimodal Pain Management (Other)

Trial Overview 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.

Participant Groups

Group I: Standard oral hydrocodone-acetaminophen post-op management Active Control 1 Intervention

Group II: Multimodal pain post-op management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine) Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University