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Comparing Perioperative Outcomes in Pain Control

Primary Purpose

Post-operative Pain

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Multimodal Pain Management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard oral hydrocodone-acetaminophen post-op management

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

Arm Description

Outcomes

Primary Outcome Measures

Morphine equivalents used
Morphine equivalents used over 1 year

Secondary Outcome Measures

Pain Score (0-10, 0=no pain, 10=most severe pain)
Number of Complications

Full Information

First Posted
December 19, 2022
Last Updated
May 5, 2023
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT05690282
Brief Title
Comparing Perioperative Outcomes in Pain Control
Official Title
Randomized Controlled Trial Comparing Multimodal Pain Protocol Versus Hydrocodone-Acetaminophen for Post-Operative Pain Management in Orthopaedic Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
May 17, 2024 (Anticipated)
Study Completion Date
May 17, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard oral hydrocodone-acetaminophen post-op management
Arm Type
No Intervention
Arm Title
Multimodal pain post-op management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Multimodal Pain Management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)
Intervention Description
Multimodal Pain Management to minimize patients' reliance on opioids.
Primary Outcome Measure Information:
Title
Morphine equivalents used
Description
Morphine equivalents used over 1 year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Pain Score (0-10, 0=no pain, 10=most severe pain)
Time Frame
1 year
Title
Number of Complications
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparing Perioperative Outcomes in Pain Control

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