Comparing Perioperative Outcomes in Pain Control

NCT ID: NCT05690282

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-17

Study Completion Date

2026-05-17

Brief Summary

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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

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Conditions

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Post-operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard oral hydrocodone-acetaminophen post-op management

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Multimodal Pain Management to minimize patients' reliance on opioids.

Interventions

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

Multimodal Pain Management to minimize patients' reliance on opioids.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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William Kent

Assistant Professor of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, San Diego

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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210031

Identifier Type: -

Identifier Source: org_study_id

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