Preemptive Tapentadol on Post-operative Analgesia Following Total Knee Arthroplasty
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional

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
    

Detailed description: 
      METHODOLOGY

        -  Consent: Participants will be explained the benefit and harm of joining the study and
           the freedom of withdrawing from the study at any moment they would like to. A full
           voluntary written informed consent will be obtained from each participant. Study will be
           conducted following the principles of Helsinki after getting written permission of the
           institutional ethics committee. Before enrolment of first subject in this study
           registration for clinical trial will be done.

        -  Participants: Patients of either sex, above 18 yrs. of age undergoing Total Knee
           Arthroplasty will be the participants in this study.

           1. Inclusion Criteria:

        -  Patients both males and females undergoing elective total knee replacement surgery

        -  Patients are capable to provide an informed consent

        -  Age 18-75 yrs.

           2. Exclusion Criteria:

        -  Patients with Asthma, COPD or any other respiratory disease.

        -  Persistent nausea and vomiting at the time of randomization.

        -  Epilepsy.

        -  Treated with mono amine oxidase inhibitors, tricyclic antidepressants, serotonin
           norepinephrine re uptake inhibitors.

        -  Patients with ASA grading 3 or more.

        -  Drug abuse history.

        -  Opioid tolerance or opioid dependence.

        -  Renal disease(creatinine>1.5 mg/dl).

        -  Liver disease (total bilirubin>1.5 mg/dl).

        -  Known history of opioid allergies.

        -  Major psychiatric disorder.

        -  Pregnancy and lactation.

        -  Emergency surgery.

        -  Bone tumor

        -  Migraine patients or patients complaining dizziness, vertigo.

      Screening: The trial will be comprised of complete medical history and physical examination
      and screening. Pre-operative laboratory investigations will be recorded in case record form.

        -  Randomization: A total of 90 Participants will be selected by computer generated random
           list.

        -  Blinding: The study will be conducted in a double blinded manner.

        -  Treatment Administration and baseline follow up: The participants will be assigned to
           receive 100 mg of Tapentadol or a matched placebo orally 1 hr before spinal anesthesia
           in a double-blind manner. All the participants, both control and Tapentadol group will
           be anesthetized (SP) as per the standard protocol after similar pre-medication. Single
           dose of injection Paracetamol 1 gm i.v. will be provided in both the groups immediately
           after operation.

        -  Assessment of efficacy and safety and Duration: All the subjects will be assessed for
           pain at rest, before surgery, at 0, 6 12 &, 24 hrs. post operatively by visual analogue
           scale score(VAS) (0 mm: no pain,100 mm: Worst pain imaginable).16 and TOTPAR
           SCALE(None-Mild-Moderate-Severe) *. They also will be evaluated for nausea, vomiting,
           drowsiness, and pruritus and will be rated on0,6,12, & 24 hrs.16. Total rescue analgesic
           consumption also will be assessed at 24 hrs post operatively 16. The time of 1st request
           for supplemental analgesia also will be recorded. A blood sample will be obtained from
           each participant at 0 hrs. post operatively to measure the tapentadol concentration and
           Cholecystokinin by ELISA method.
    

Intervention name(s): Tapentadol 100 MG; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Tapentadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment