Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Surgery
Status:
Completed
Trial end date:
2020-05-19
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar