Preemptive Tapentadol on Post-operative Analgesia Following Total Knee Arthroplasty

NCT03351517 | Completed DMC

• 1 other identifier: T/IM-NF/Pharma/02/17
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The study intends to evaluate the efficacy of Tapentadol against placebo as a preemptive analgesic in the management of post-operative pain in the patiens undergoing total knee arthroplasty. The primary objective is to evaluate th epain score in visual analogue scale at various time points within 24 hours post operarively

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Assessment of Change of Pain score compared to plecebo by visual analogue scale

  All the subjects will be assessed for pain at various time points post-operatively by visual analogue scale(VAS) (minimum value 00- no pain to maximum value-100 - worst pain imaginable) Higher values indicate worse outcome

  24 hrs. post-operatively( 0,2,4,6,12,24 hrs post operatively)

Study Arms (2)

Tapentadol arm

EXPERIMENTAL

Single dose of 100 mg of extended release oral tapentadol will be administered 1 hour before surgery.

Drug: Tapentadol 100 MG

Placebo arm

PLACEBO COMPARATOR

A comparable placebo will be administered 1 hour before surgery.

Drug: Placebo Oral Tablet

Interventions

Tapentadol 100 MG DRUG

100 mg of oral extended release tapentadol will be given to the patients undergoing total knee replacement surgery on spinal anesthesia to evaluate its efficacy in the management of post-operative pain.

Tapentadol arm

Placebo Oral Tablet DRUG

A matching placebo will be given to the patients undergoing total knee replacement surgery on spinal anesthesia to evaluate its efficacy in the management of post-operative pain.

Placebo arm

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 of either sex undergoing elective tota knee replacement surgery
• Patients are capable to provide an informed consent
• Age 18-65 years

You may not qualify if:

• Patients with Asthma, copd or any other respiratory disease
• Persistent nausea , vomiting at the time of randomization
• Treated with MAO inhibitors, Tricyclic antidepressants, SSRIs and SNRIs
• Patients with ASA grading 3 or more
• Drug abuse history, opioid tolerance or dependence, known history of opiod allergies
• Renal or liver disease
• Major psychiatric disorder
• Pregnancy and lactation
• Emergency surgery
• Bone tumor, epilepsy or patients with migraine

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

All India Institute of Medical Sciences

Bhubaneswar, Odisha, 751019, India

Location

MeSH Terms

Conditions

Agnosia

Interventions

Tapentadol

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• DEBASISH HOTA, MD,DM

  AIIMS Bhubaneswar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof and Head of the Department

Study Record Dates

• First Submitted: November 11, 2017
• First Posted: November 24, 2017
• Study Start: November 1, 2017
• Primary Completion: August 20, 2018
• Study Completion: September 7, 2018
• Last Updated: September 10, 2018

Record last verified: 2018-09

Locations

IN (1)