Efficacy of NSAID and Acetaminophen in the Control of Post-Operative Pain in Patients Undergoing Total Knee Replacement

NCT05393414 | Completed

• 1 other identifier: B0110219
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

An alternate perioperative pain control protocol composed of intravenous ketorolac and oral acetaminophen for patients who underwent total knee replacement was designed with the aim to determine its efficacy when compared to pain control with intravenous morphine and oral oxycodone combined with acetaminophen. In addition, the study will evaluate the differences and similarities in the Hispanic population that could predict protocol efficacy.

Conditions

Pain; Hispanics; Opioid Use; Multimodal Analgesia; Total Knee Arthroplasty

Keywords

Total Knee Arthroplasty; Postoperative Pain; Opioid Use; Hispanics; Clinical Outcomes; Multimodal Analgesia

Outcome Measures

Primary Outcomes (3)

• Pain scores using numerical rating scale (NRS, 0 to 10)

  The amount of pain intensity reported will be measure throughout the numerical rating scale. Each patient will rate their pain intensity on a scale from 0 to 10, where zero represents "no pain," whereas 10 represents the "most intense pain" (e.g., "the most intense pain imaginable," "the maximum pain intensity as it could be"); during the 12 hours postoperative period

  Post-operative 12 hours after surgery

• Pain scores using numerical rating scale (NRS, 0 to 10)

  The amount of pain intensity reported will be measure throughout the numerical rating scale. Each patient will rate their pain intensity on a scale from 0 to 10, where zero represents "no pain," whereas 10 represents the "most intense pain" (e.g., "the most intense pain imaginable," "the maximum pain intensity as it could be"); during the 24 hours postoperative period

  Post-operative 24 hours after surgery

• Pain scores using numerical rating scale (NRS, 0 to 10)

  The amount of pain intensity reported will be measure throughout the numerical rating scale. Each patient will rate their pain intensity on a scale from 0 to 10, where zero represents "no pain," whereas 10 represents the "most intense pain" (e.g., "the most intense pain imaginable," "the maximum pain intensity as it could be"); during the 48 hours postoperative period

  Post-operative 48 hours after surgery

Secondary Outcomes (2)

• Hospital Length of Stay

  up to 30 days

• Drug-related adverse events

  From the time of surgery after being discharge (0 to 72 hours after surgery)

Study Arms (2)

Opioid Sparing Multimodal Regimen

EXPERIMENTAL

After surgery, the experimental group will receive a combination of ketorolac 30 mg intravenous (IV) every six hours for patients younger than 65 years old or ketorolac 15mg IV every six hours for those older than 65 years old; and acetaminophen 1 gram by mouth (PO) every six hours up to 72 hours

Drug: Opioid sparing protocol

Opioid Based Multimodal Regimen

EXPERIMENTAL

After surgery, the control group will receive a combination of morphine 0.1 mg/kg IV every six hours and oxycodone combined with acetaminophen (2.5 mg / 325 mg) two tabs PO every six hours up to 72 hours

Drug: Opioid based protocol

Interventions

Opioid based protocol DRUG

Use of combination of drug dosage frequency and duration of morphine injection with percocet oral as standard postoperative pain control for up to 72 hours as requested by each patient

Also known as: morphine injection, percocet oral

Opioid Based Multimodal Regimen

Opioid sparing protocol DRUG

Use of combination of drug dosage frequency and duration of ketorolac injection with acetaminophen oral as standard postoperative pain control for up to 72 hours as requested by each patient

Also known as: ketorolac injection, acetaminophen oral

Opioid Sparing Multimodal Regimen

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hispanic American patients undergoing primary total knee arthroplasty
• Older than 21 years of age
• Classified with an American Society of Anesthesiologist Classification (ASA) of I or II.

You may not qualify if:

• Hypersensitivity to any components of analgesic drugs
• Impaired renal, cardiac, or hepatic function
• Baseline serum creatinine level higher than 1.2mg/dL
• History of gastrointestinal bleeding
• Neuromuscular deformities
• Inability to consent

Sponsors & Collaborators

• University of Puerto Rico: lead

Study Sites (1)

University of Puerto Rico Medical Sciences Campus, Ortopaedic Surgery Department

San Juan, 00936, Puerto Rico

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Morphine; oxycodone-acetaminophen; Ketorolac; Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Antonio Otero-Lopez, MD

  Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 26, 2022
• Study Start: November 25, 2019
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

PR (1)