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NCT Number: NCT05690282

Comparing Perioperative Outcomes in Pain Control

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Diego

San Diego, California, 92093, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Multimodal Pain Management to minimize patients' reliance on opioids.

Primary outcomes

  1. Morphine equivalents used

    Time frame: 1 year

    Morphine equivalents used over 1 year

Secondary outcomes

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

    Time frame: 1 year

  2. Number of Complications

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Jan 19, 2023
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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