NCT03604354

Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Surgery

Completed Phase 4 Last updated 25 June 2020

What this trial tests

Phase 4 trial testing Tapentadol 100 MG Oral Tablet in Osteoarthritis, Knee in 95 participants. Completed in 19 May 2020.

Timeline

1 August 2018

Primary endpoint
24 March 2020

19 May 2020

Quick facts

Lead sponsor	All India Institute of Medical Sciences, Bhubaneswar
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	95
Start date	1 August 2018
Primary completion	24 March 2020
Estimated completion	19 May 2020
Sites	1 location across India

Drugs / interventions tested

• Tapentadol 100 MG Oral Tablet — full drug profile →
• Pregabalin 150mg — full drug profile →

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Who can join

Adults 18 to 65, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.