Comparing Perioperative Outcomes in Pain Control

Phase 4

Active, not recruiting

• Conditions: Post-operative Pain
• Interventions: Drug: Multimodal Pain Management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)

• Registration Number: NCT05690282
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-17
• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-19
• Primary Completion: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Study Completion: 2026-05-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Orthopaedic injury requiring surgery
• Evaluation and treatment at UCSD
• Age 18years or older
• Ability to understand the content of the patient information/Informed Consent Form
• Signed and dated Institutional Review Board (IRB) approved written informed consent

Exclusion Criteria

• Polytrauma

• Any not medically managed severe systemic disease

• Their doctor has decided that it is in the patient's best interest to receive pain management regimen of one type vs. the other.

• The patient prefers one type of pain management protocol and is not willing to be randomized.

• Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment or confound pain control

• Pregnancy or women planning to conceive within the subject participation period (1 year)

  o Pregnancy will be self-reported and no test will be performed to test for it.

• Prisoner

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal pain post-op management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)	Multimodal Pain Management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)	-

Primary Outcome Measures

Name	Time	Method
Morphine equivalents used	1 year	Morphine equivalents used over 1 year

Secondary Outcome Measures

Name	Time	Method
Pain Score (0-10, 0=no pain, 10=most severe pain)	1 year
Number of Complications	1 year

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 San Diego, California, United States