Comparing Perioperative Outcomes in Pain Control

Randomized Controlled Trial Comparing Multimodal Pain Protocol Versus Hydrocodone-Acetaminophen for Post-Operative Pain Management in Orthopaedic Surgery Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Post-operative Pain
• Intervention / Treatment: Drug: Multimodal Pain Management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard oral hydrocodone-acetaminophen post-op management
Active Comparator: Multimodal pain post-op management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)	Drug: Multimodal Pain Management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine); Multimodal Pain Management to minimize patients' reliance on opioids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine equivalents used	Morphine equivalents used over 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Complications	1 year
Pain Score (0-10, 0=no pain, 10=most severe pain)	1 year

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): May 17, 2026

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Neurotransmitter Agents; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anticonvulsants; Antimanic Agents; Excitatory Amino Acid Agents; Excitatory Amino Acid Antagonists; Gabapentin; Bupivacaine; Acetaminophen; Ibuprofen
• Other Study ID Numbers: 210031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No