Comparing Perioperative Outcomes in Pain Control

Post-operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05690282
• Other study ID #: 210031
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 17, 2021
• Est. completion date: May 17, 2026

Study information

• Verified date: May 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 17, 2026
• Est. primary completion date: May 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• Multimodal Pain Management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)
Multimodal Pain Management to minimize patients' reliance on opioids.

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine equivalents used	Morphine equivalents used over 1 year	1 year
Secondary	Pain Score (0-10, 0=no pain, 10=most severe pain)		1 year
Secondary	Number of Complications		1 year