Comparing Perioperative Outcomes in Pain Control

NCT05690282 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 210031
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

• Morphine equivalents used

  Morphine equivalents used over 1 year

  1 year

Secondary Outcomes (2)

• Pain Score (0-10, 0=no pain, 10=most severe pain)

  1 year

• Number of Complications

  1 year

Study Arms (2)

Standard oral hydrocodone-acetaminophen post-op management

NO INTERVENTION

Multimodal pain post-op management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)

ACTIVE COMPARATOR

Drug: Multimodal Pain Management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)

Interventions

Multimodal Pain Management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine) DRUG

Multimodal Pain Management to minimize patients' reliance on opioids.

Multimodal pain post-op management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 19, 2023
• Study Start: May 17, 2021
• Primary Completion: December 31, 2024
• Study Completion: May 17, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)