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

Primary Purpose

Pain, Hispanics, Opioid Use

Status
Completed
Phase
Not Applicable
Locations
Puerto Rico
Study Type
Interventional
Intervention
Opioid based protocol
Opioid sparing protocol
Sponsored by
University of Puerto Rico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Total Knee Arthroplasty, Postoperative Pain, Opioid Use, Hispanics, Clinical Outcomes, Multimodal Analgesia

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Puerto Rico Medical Sciences Campus, Ortopaedic Surgery Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Opioid Sparing Multimodal Regimen

Opioid Based Multimodal Regimen

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Hospital Length of Stay
The number of days per patient from the time of admission to discharge up to 30 days
Drug-related adverse events
nausea, dizziness, vomit, tachycardia, pruritus and headache

Full Information

First Posted
May 13, 2022
Last Updated
May 23, 2022
Sponsor
University of Puerto Rico
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1. Study Identification

Unique Protocol Identification Number
NCT05393414
Brief Title
Efficacy of NSAID and Acetaminophen in the Control of Post-Operative Pain in Patients Undergoing Total Knee Replacement
Official Title
Efficacy of NSAID and Acetaminophen in the Control of Post-Operative Pain in Patients Undergoing Total Knee Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Puerto Rico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Acute pain after a surgical procedure may occur secondary to trauma from the procedure itself or from procedure-related complications. Appropriate peri-operative acute pain management is an important phase of patient's recovery since it's under-treatment can lead to adverse outcomes such as: thromboembolic and pulmonary complications, additional time spent in an intensive care unit or hospital, hospital readmission for further pain management, needless suffering, impairment of health-related quality of life, and development of chronic pain. Furthermore, it's over-treatment with opioid medications is associated with an increased risk of thromboembolic, infectious and gastrointestinal complications as well as increased length of hospital stay, cost of care and risk of opioid addiction. Perioperative administration of intravenous (IV) non steroidal anti-inflammatory drugs (NSAID), such as ketorolac, has been shown to effectively decrease opioid requirements and pain levels while demonstrating tolerable side effects. Its use after total knee replacement has been associated with a 27% decrease in the use of morphine. When NSAID is combined with acetaminophen 1000mg every six hours, an additional benefit in terms of improved pain scores on post-operative day three was shown in patients who underwent total hip or knee arthroplasty. Therefore, the purpose of this study is to provide an effective alternative for pain management in Hispanic patients who underwent total knee replacement and evaluate the role of ketorolac and acetaminophen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Hispanics, Opioid Use, Multimodal Analgesia, Total Knee Arthroplasty
Keywords
Total Knee Arthroplasty, Postoperative Pain, Opioid Use, Hispanics, Clinical Outcomes, Multimodal Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Opioid Sparing Multimodal Regimen
Arm Type
Experimental
Arm Description
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
Arm Title
Opioid Based Multimodal Regimen
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Opioid based protocol
Other Intervention Name(s)
morphine injection, percocet oral
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Opioid sparing protocol
Other Intervention Name(s)
ketorolac injection, acetaminophen oral
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain scores using numerical rating scale (NRS, 0 to 10)
Description
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
Time Frame
Post-operative 12 hours after surgery
Title
Pain scores using numerical rating scale (NRS, 0 to 10)
Description
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
Time Frame
Post-operative 24 hours after surgery
Title
Pain scores using numerical rating scale (NRS, 0 to 10)
Description
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
Time Frame
Post-operative 48 hours after surgery
Secondary Outcome Measure Information:
Title
Hospital Length of Stay
Description
The number of days per patient from the time of admission to discharge up to 30 days
Time Frame
up to 30 days
Title
Drug-related adverse events
Description
nausea, dizziness, vomit, tachycardia, pruritus and headache
Time Frame
From the time of surgery after being discharge (0 to 72 hours after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Otero-Lopez, MD
Organizational Affiliation
Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Puerto Rico Medical Sciences Campus, Ortopaedic Surgery Department
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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