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

Sponsor

University of Puerto Rico (Other)

Overall Status

Completed

CT.gov ID

NCT05393414

Collaborator

(none)

Enrollment

Location

Arms

3.5

Actual Duration (Months)

22.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Hispanics Opioid Use Multimodal Analgesia Total Knee Arthroplasty	Drug: Opioid based protocol Drug: Opioid sparing protocol	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 25, 2019

Actual Primary Completion Date :

Mar 12, 2020

Actual Study Completion Date :

Mar 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Opioid Sparing Multimodal Regimen 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 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 Other Names: ketorolac injection acetaminophen oral
Experimental: Opioid Based Multimodal Regimen 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 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 Other Names: morphine injection percocet oral

Arm

Intervention/Treatment

Experimental: Opioid Sparing Multimodal Regimen

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

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

Other Names:

ketorolac injection

acetaminophen oral

Experimental: Opioid Based Multimodal Regimen

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

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

Other Names:

morphine injection

percocet oral

Outcome Measures

Primary Outcome Measures

Pain scores using numerical rating scale (NRS, 0 to 10) [Post-operative 12 hours after surgery]
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) [Post-operative 24 hours after surgery]
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) [Post-operative 48 hours after surgery]
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 [up to 30 days]
The number of days per patient from the time of admission to discharge up to 30 days
Drug-related adverse events [From the time of surgery after being discharge (0 to 72 hours after surgery)]
nausea, dizziness, vomit, tachycardia, pruritus and headache

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 110 Years

Sexes Eligible for Study:

All

Accepts 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.