Pain Clinical Trial
Official title:
Efficacy of NSAID and Acetaminophen in the Control of Post-Operative Pain in Patients Undergoing Total Knee Replacement
Verified date | May 2022 |
Source | University of Puerto Rico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | University of Puerto Rico Medical Sciences Campus, Ortopaedic Surgery Department | San Juan |
Lead Sponsor | Collaborator |
---|---|
University of Puerto Rico |
Puerto Rico,
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) |
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