postoperative pain

Phase 3

Not yet recruiting

• Conditions: Measurement and Monitoring,

• Registration Number: CTRI/2019/02/017850
• Lead Sponsor: Akums Drugs Pharmaceutical Ltd India

Brief Summary

This will be a phase III, multi-centric, comparative, randomized, double blind, parallel group, clinical study. The study will begin with screening evaluation. Clinical test reports (If available) of patients will be assessed at screening. Patients of ASA(American Society of Anesthesiologists) physical status I and II determined to undergo elective surgery of any etiology under general anesthesia (Hip/Knee Arthroplasty, Open Cholecystectomy) satisfying all the inclusion criteria at randomization visit will be randomized to either of the study arms after surgery.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-02-26
• Study Start: 2019-05-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 1 Patients of ASA(American Society of Anesthesiologists) physical status I and II determined to undergo elective surgery of any etiology under general anesthesia (Hip/Knee Arthroplasty, Open Cholecystectomy).
• 2 Hospital stay at least for 24 hours is needed.
• 3 Cooperative and understanding skills.
• 4 Agreement to informed consent form.

Exclusion Criteria

• 1 Hypersensitivity to any of the drugs components or other drug from same class.
• 2 Patient unable to refrain from alcohol, psychoactive drugs, and sedatives including sleeping preparations (e.g. benzodiazepines) for the duration of their participation in the study 3 Patient with history of drug of abuse.
• 4 Patients at risk for respiratory depression, patients with increased intracranial pressure or head injury, suffering from severe headache.
• 5 Pregnant and lactating woman.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine change in Visual Analog scale pain score	at day 1 (48 hours), day 2 (72 hours) and at end of study from baseline,

Secondary Outcome Measures

Name	Time	Method
To determine change in Visual Analog scale pain score	till 24 hours (average cumulative scores during 24 hours post dose) as compared to baseline score.

Trial Locations

Locations (1)

Ashirwad Hospital and Research Centre; 🇮🇳 Thane, MAHARASHTRA, India

Ashirwad Hospital and Research Centre

🇮🇳Thane, MAHARASHTRA, India

Dr Shrikant Deshpande

Principal investigator

9987553071

pm_medaffairs@nexuscro.com