CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 250 enrolled
Drug / intervention
Multimodal analgesia including pregabalin +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04471233
NCT04471233N/ACompleted

Influence of Patient Sex on Pain Control and Multimodal Analgesia in Total Knee Arthroplasty

Northwell Health·interventional·Posted Jul 15, 2020·Updated Oct 1, 2024

In Brief

A clinical study evaluating Multimodal analgesia including pregabalin and Multimodal analgesia not including pregabalin for Knee Osteoarthritis and Pain, Postoperative. Completed, enrolled 250 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the influence of sex on postoperative pain, following total knee arthroplasty (TKA). Patients will first be stratified by sex and then be randomized into one of two multimodal analgesic regimen (MAR), which differ in presence of pregabalin. We hypothesize that that acute postoperative pain scores are different over time between males and females and between multimodal analgesic regimens following TKA. Investigators will be blinded to which multimodal group patients are in. Patients will complete surveys in the office, during their hospital stay, and at followup intervals for up to six months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 15, 2020
Enrollment StartDec 9, 2020
Primary CompletionJun 20, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.0 years ago

Interventions

Multimodal analgesia including pregabalinother

Standardized protocol for our institution with multiple medications used for pain (NSAIDs, opioids, dexamethasone) and non-narcotic spinal. Patient will be provided with an preoperative pregabalin dose and will continue medication two weeks postoperatively.

Multimodal analgesia not including pregabalinother

Standardized protocol for our institution with multiple medications used for pain (NSAIDs, opioids, dexamethasone) and non-narcotic spinal.