Etodolac injection in post operative orthopedic pain.

Phase 3

Completed

• Conditions: Post Operative Orthopedic pain

• Registration Number: CTRI/2010/091/000437
• Lead Sponsor: Ipca Laboratories Limited

Brief Summary

This is a randomized, assessor blind, comparative, multicentric study. The investigator will obtain written informed consent from the patient before screening. Additional 100 patients undergoing elective orthopedic surgeries will be enrolled as per the inclusion and exclusion criteria. After surgery, all inclusion/exclusion criteria will be evaluated. Patients who satisfy the inclusion and exclusion criteria will be randomized in to two treatment arms.Total study duration will be 24 hours. After one week of study completion, the telephonic follow up will be done by the investigator to evaluate the safety of study drug. In this follow up, investigator will ask the patients about any AE/SAE experienced by them.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-26
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Male and female patients aged 18 to 65 years 2.
• Satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition 3.
• Patients who are undergoing any of the following elective orthopedic surgeries such asknee arthroscopy, repair of femoral neck fracture, repair of trochanteric fracture, repair of ankle fracture (bimalleolar type), repair of femoral or tibial fracture, fixation for foot injuries, fixation for pelvic fractures and repair of patella fracture.
• 4.Patients with the post operative orthopedic pain of at least 5cm on the 10cm pain intensity Visual Analogue Scale and at least a score of 2 on 4 point verbal rating scale 5.
• Patients fulfilling the American Society of Anesthesiology (ASA) I or II or III criteria for post operative orthopedic pain 6.
• The subject must understand and be able, willing and likely to fully comply with study procedures and ready to give written informed consent.

Exclusion Criteria

• Patients having complication during or after surgical procedure2.
• Patients with abnormal renal and liver function3.
• Patients with significant medical illness4.
• Patient having any concomitant medication, which may interact with action of study drugs.
• Patients with known history of hypersensitivity to NSAIDS or diclofenac or any other ingredient of the study medication or other similar drugs of same chemical class 7.
• Pregnant or lactating women8.
• Women of childbearing potential not practicing contraception.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean fall in pain intensity	At 15 min, 30 min, 1 hr and then 2, 4, 6, 8, 12, 16, 20 and 24 hours

Secondary Outcome Measures

Name	Time	Method
Total doses of rescue medication consumed	In the entire study duration
Safety and toleability of study medication	throughout the duration of study

Trial Locations

Locations (11)

Calicut Medical College; 🇮🇳 Thiruvananthapuram, KERALA, India

Department of Orthopedics GRMC , Gwalior; 🇮🇳 Gwalior, MADHYA PRADESH, India

Dr DY Patil Medical College; 🇮🇳 Pune, MAHARASHTRA, India

GSVM Medical College; 🇮🇳 Lucknow, UTTAR PRADESH, India

King George Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

Mahatma Gandhi Medical College & Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Mysore Medical College and Research Institute, K. R. Hospital, Mysore; 🇮🇳 Mysore, KARNATAKA, India

Sheth Vadilal Sarabhai General Hospital &; 🇮🇳 Ahmadabad, GUJARAT, India

Vivekananda Institute of Medical Sciences; 🇮🇳 Kolkata, WEST BENGAL, India

Vydehi Institute of Medical Sciences and Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

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Calicut Medical College

🇮🇳Thiruvananthapuram, KERALA, India

Dr M K Ravindran

Principal investigator

09447023525

raveendranmk@gmail.com