CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 95 enrolled
Drug / intervention
Tapentadol 100 MG Oral Tablet +1 moredrug
Likely dose
Tapentadol 100 MG Oral Tabletfrom 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/NCT03604354
NCT03604354Phase 4Completed

Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Unilateral Total Knee Arthroplasty- A Randomised, Double Blind, Active Control, Clinical Trial

All India Institute of Medical Sciences, Bhubaneswar·interventional·Posted Jul 27, 2018·Updated Jun 25, 2020

In Brief

A Phase 4 clinical trial evaluating Tapentadol 100 MG Oral Tablet and Pregabalin 150mg for Osteoarthritis, Knee. Completed, enrolled 95 participants across 1 site.

Detailed Summary

Preemptive analgesia is a treatment modality which starts even before the surgery, so that the central sensitization is prevented due to incisional injury at the time of surgery, so it covers the period of surgery and initial post-operative period preventing the development of central sensitization. Gabapentinoid compounds are gabapentin and pregabalin which have been extensively used in seizure disorder patient. Role of gabapentinoid compounds in the management of pain, as a pre-emptive analgesia is yet to be completely evaluated in post operative pain. Opioids have always been the preferred drugs to manage post operative pain. Since opioids have major side effects of nausea vomiting associated with its treatment their use comes with management of these side effects. Currently, diagnostic and therapeutic approaches to manage pain experienced by individuals are limited especially because there's a lack of bio-markers predictive of therapeutic outcome. In search of an objective method for pain measurement, as pain has always been subjective and it is perceived by different people differently the study will also include finding the use of COX(cyclo-oxygenase)-2 as a bio-marker of pain in post-operative patients. Although several randomized clinical trials and met-analyses have been conducted comparing the safety and efficacy of tapentadol or pregabalin in post-operative pain, there is no head to head clinical trial conducted comparing the preemptive use of two drugs for postoperative pain following total knee arthroplasty (TKA). Hence the present study is planned.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJul 27, 2018
Enrollment StartAug 1, 2018
Primary CompletionMar 24, 2020
Study CompletionMay 19, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.9 years ago

Interventions

Tapentadol 100 MG Oral Tabletdrug

This arm will receive drugs one hour before undergoing unilateral total knee arthroplasty. Interventions tapentadol 100mg oral tablets.

Pregabalin 150mgdrug

This arm will receive drugs one hour before undergoing unilateral total knee arthroplasty. Interventions pregabalin 150mg oral tablets.