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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05393414
• Other study ID #: B0110219
• Status: Completed
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: March 12, 2020

Study information

• Verified date: May 2022
• Source: University of Puerto Rico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Multimodal Analgesia
• Opioid Use
• Pain
• Pain, Postoperative
• Total Knee Arthroplasty

Intervention

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
• 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

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico Medical Sciences Campus, Ortopaedic Surgery Department	San Juan

Sponsors (1)

Lead Sponsor	Collaborator
University of Puerto Rico

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Hospital Length of Stay	The number of days per patient from the time of admission to discharge up to 30 days	up to 30 days
Secondary	Drug-related adverse events	nausea, dizziness, vomit, tachycardia, pruritus and headache	From the time of surgery after being discharge (0 to 72 hours after surgery)