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

NCT03604354 | Completed Phase 4

• 1 other identifier: IEC/AIIMSBBSR/PGTH/18/12
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

OA knee,pre-emptive analgesia,TKA,Opioids,gabapentinoids

Outcome Measures

Primary Outcomes (1)

• Efficacy and safety of pregabalin and tapentadol by measuring the mean difference in the mean VAS score.

  Visual analogue scale (VAS) from 0 to 100 mm score at 0,6,12,24 hrs. post operatively in both the groups.

  Evaluated over 24hrs post unilateral total knee arthroplasty

Secondary Outcomes (6)

• Comparing differences in TOTPAR scale through different time points of 24 hours Comparing differences in TOTPAR (none, mild, moderate and severe) scale through different time points of 24 hours

  Recorded over 24hrs post unilateral total knee arthroplasty

• Measuring the rescue analgesic requirement in both the groups

  Recorded over 24hrs post unilateral total knee arthroplasty

• Monitoring adverse events in both the groups including post-operative nausea vomiting (PONV)

  Recorded over 24hrs post unilateral total knee arthroplasty

• Percentage of adverse events in a 4-point verbal scale.

  Recorded over 24hrs post unilateral total knee arthroplasty

• Estimation of COX-2 at 0hrs and 6hrs post operatively in both the groups by ELISA.

  In two blood samples one at 0hrs and 6hrs post operatively

Study Arms (2)

Pregabalin

ACTIVE COMPARATOR

Pregabalin 150mg oral tablets before one hour before undergoing unilateral total knee arthroplasty

Drug: Pregabalin 150mg

Tapentadol

EXPERIMENTAL

tapentadol 100mg oral tablets before one hour before undergoing unilateral total knee arthroplasty

Drug: Tapentadol 100 MG Oral Tablet

Interventions

Tapentadol 100 MG Oral Tablet DRUG

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

Tapentadol

Pregabalin 150mg DRUG

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

Pregabalin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients both males and females undergoing total knee arthroplasty surgery. 2. Patients are capable of providing an informed consent. 3. Age group between 18-75 years.

You may not qualify if:

• Patients with asthma, COPD or any other respiratory disease. 2. Persistent nausea and vomiting at time of randomization 3. Epilepsy. 4. Treated with mono amine oxidase inhibitors, tricyclic antidepressants, serotonin norepinephrine re-uptake inhibitors, gabapentinoids.
• \. Patient with known neurological/ neuropsychiatric disorders. 6. Drug or alcohol abuse history 7. Opioid tolerance or opioid dependence. 8. Known history of opioid allergy or pregabalin allergy. 9. Renal disease (creatinine \>1.5mg/dl) 10. Liver disease (total bilirubin \>1.5mg/dl) 11. Pregnancy and lactation. 12. Cardiovascular insufficiency. 13. Patient with potential serotonin syndrome. 14. Patient with history of constipation and prone to paralytic ileus.

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

All India Institute of Medical Sciences

Bhubaneswar, Odisha, 751019, India

Location

Related Publications (17)

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MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Tapentadol; Tablets; Pregabalin

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Debasish Hota, MD;DM

  AIIMS BHUBANESWAR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will be participant and investigator blinded. Allocation concealment will be done by sequentially numbered sealed drug pouches.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR AND HEAD OF THE DEPARTMENT PHARMACOLOGY

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: August 1, 2018
• Primary Completion: March 24, 2020
• Study Completion: May 19, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)