A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery

NCT04015908 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 121505
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to determine whether the combination of three non-opioid analgesics (multimodal analgesia) can significantly reduce or eliminate the need for opioids after ambulatory surgery. A secondary objective would be to present credible data for insurance providers about the opioid sparing effect of these medications. This data may encourage insurance providers to support payment for short term use of certain analgesics that currently require prior authorization.

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

• Amount of Pain Experienced

  Pain as measured by a 0-10 Visual Analog Scale (VAS) pain scale, where "0" is the lowest score and "10" is the highest score. For example, 10 would be severe pain and 0 would be none. Cumulative scores were the total scores over 6 days and were expressed with the absolute totals with range. No subscales were used. Cumulative scores represent the absolute sum of each data point for 6 days. The total cumulative range for pain is 0-60.

  Cumulative every day after 6 days post-operative

Secondary Outcomes (3)

• Amount of Nausea Experienced

  Cumulative every day after 6 days post-operative

• Amount of Itching Experienced

  Cumulative every day after 6 days post-operative

• Amount of Oxycodone Used

  Cumulative every day after 6 days post-operative

Study Arms (2)

multi-modal

EXPERIMENTAL

3 Different Non-opioid pain medication taken every 6 hours Celecoxib 100mg Acetaminophen 325mg Pregabalin 50 mg Plus, for breakthrough pain oxycodone 5-10 mg will be taken every 4 hours as needed for pain.

Drug: Celecoxib; Drug: Acetaminophen; Drug: Pregabalin; Drug: Oxycodone

Control

ACTIVE COMPARATOR

7 day supply of Percocet (oxycodone 5mg/acetaminophen 325 mg) to be taken 1-2 by mouth every 4 hours as needed for pain.

Drug: Percocet

Interventions

Celecoxib DRUG

Celecoxib 100mg

Also known as: Celebrex

multi-modal

Acetaminophen DRUG

Acetaminophen 325mg

Also known as: Paracetamol

multi-modal

Pregabalin DRUG

Pregabalin 50 mg

Also known as: Lyrica

multi-modal

Oxycodone DRUG

oxycodone 5-10 mg

Also known as: Xtampza ER, Oxaydo, Roxicodone

multi-modal

Percocet DRUG

Percocet (oxycodone 5mg/acetaminophen 325 mg)

Also known as: Oxycodone / Paracetamol

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients between the ages of 18 and 65 having one of three elective procedures as an outpatient. These procedures are associated with moderate to severe postoperative pain (anterior cruciate ligament reconstruction (knee), ankle ligament reconstruction (foot/ankle), or ligament reconstruction with tendon interposition (hand))
• Patients should have operative risk category of American Society of Anesthesiologists (ASA) 1 or 2 .
• Patients weighing between 70-100kg will be included to allow standardization of medication dosing

You may not qualify if:

• Allergy to Study Medications
• Previous History of Chronic Opioid Use
• Patient Refusal to Participate
• Known of Suspected History of Sleep Apnea
• Known History of Chronic Pain Syndrome
• Weight less than 70kg or greater than 100kg due to standardization of medication doses.
• Revision Surgery
• Inability to take study medications due to medication incompatibility or co-existing disease
• Patients refusing or unable to receive US guided nerve block for postoperative pain
• Patients unable to read and comprehend written consent document

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Swenson JD, Conrad KM, Pace NL, Phillips K, Saltzman CL. Scheduled, Simultaneous Dosing of Pregabalin, Celecoxib, and Acetaminophen Markedly Reduces or Eliminates Opioid Use After ACL Reconstruction Using Allograft or Hamstring Tendon Autograft: A Randomized Clinical Trial. Orthop J Sports Med. 2022 Dec 8;10(12):23259671221140837. doi: 10.1177/23259671221140837. eCollection 2022 Dec.

  PMID: 36518729 DERIVED

MeSH Terms

Interventions

Celecoxib; Acetaminophen; Pregabalin; Oxycodone; oxycodone-acetaminophen

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

An important limitation of this trial is the inability to discern the true effects of medication delivery and medications received. This effect could only be measured by studying these 2 interventions separately. Similarly, this dosing regimen was applied to patients with a fixed range of weights and ages. The study design may have discouraged patients who prefer opioid analgesia. This could cause a sampling bias leading only patients motivated to use less opioid to participate.

Results Point of Contact

• Title: Dr. Jeffrey D. Swenson
• Organization: University of Utah

jeff.swenson@hsc.utah.edu

801-581-6393

Study Officials

• Jeffrey Swenson, MS

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 11, 2019
• Study Start: August 1, 2019
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: July 8, 2024
• Results First Posted: July 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)