Comparing Perioperative Outcomes in Pain Control

• Sponsor: University of California, San Diego (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05690282
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post-operative Pain	Drug: Multimodal Pain Management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial Comparing Multimodal Pain Protocol Versus Hydrocodone-Acetaminophen for Post-Operative Pain Management in Orthopaedic Surgery Patients
• Actual Study Start Date: May 17, 2021
• Anticipated Primary Completion Date: May 17, 2024
• Anticipated Study Completion Date: May 17, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Morphine equivalents used [1 year]

   Morphine equivalents used over 1 year

Secondary Outcome Measures

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

2. Number of Complications [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	San Diego	California	United States	92093

Sponsors and Collaborators

• University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: William Kent, Assistant Professor of Orthopaedic Surgery, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT05690282
• Other Study ID Numbers: 210031
• First Posted: Jan 19, 2023
• Last Update Posted: Jan 19, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Pain, Postoperative; Acetaminophen; Ibuprofen; Gabapentin; Bupivacaine

Study Results

No Results Posted as of Jan 19, 2023