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

NCT03604354 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2020-06-25

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Tapentadol 100 MG Oral Tablet

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

DRUG

Pregabalin 150mg

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

Sponsors & Collaborators

  • All India Institute of Medical Sciences, Bhubaneswar

    lead OTHER

Principal Investigators

  • Debasish Hota, MD;DM · AIIMS BHUBANESWAR

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2020-03-24
Completion
2020-05-19

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03604354 on ClinicalTrials.gov