To compare the effectiveness and safety of Inj Diclofenac 75mg/ml given intradeltoid with Injection Diclofenac 75mg/3ml given intragluteal in the management of postoperative pain.

Phase 4

Completed

• Conditions: Post Operative Pain

• Registration Number: CTRI/2008/091/000216
• Lead Sponsor: Troikaa Pharmaceuticals Limited

Brief Summary

Non steroidal anti inflammatory drugs are alternatives to opioids as sole analgesic after minor surgery or as adjuvant to opioid analgesics following major surgery. One of the most commonly used NSAID for postoperative pain is diclofenac. Currently injection diclofenac is available as a 3 ml formulation and needs to be given deep intra-muscular usually intra-gluteal. A new formulation of injection diclofenac with reduced injection volume (1ml) has recently become available for clinical practice. Due to a lower injection volume it can also be given intra-deltoid. The aim of the study is to compare the efficacy and safety of the newer 1 ml formulation of injection diclofenac with the existing formulation in the management of post operative pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-16
• Last Update Posted: 2012-10-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1.Patients in the age group of 18-65 years 2.Patients of both sexes 3.Patients with healthy deltoid/ gluteal muscle mass 4.Patients undergoing operative procedures requiring hospitalization for at least 48 hours with moderate to severe pain 5.Patients with moderate to severe pain at baseline (VAS 4 -10).

Exclusion Criteria

1.Patients below 18 years and above 65 years of age2.OPD patients/ patients requiring hospitalization less than 48 hours3.Patients with compromised renal function4.Pregnant and lactating women 5.Patients with history of bronchial asthma, peptic ulceration, bronchitis6.Patients with bleeding disorders7.Mentally retarded patients8.Unwilling patients9.Patients with known hypersensitivity to diclofenac sodium any other NSAIDs or any component of either of the study formulations10.Patients with mild baseline pain (1-3).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intensity of post operative pain as assessed by visual analogue scale (VAS)	At the end of 1, 4, 8 and 12 hours as compared to basal after each dose.

Secondary Outcome Measures

Name	Time	Method
Pain at the site of injection as assessed by visual analogue scale (VAS)	At 1 hour and 12 hours after each dose.
Systemic Adverse Reactions and Rescue Medication	Upto 48 hours.
Global efficacy by patients and investigator.	End of Study (After 48 hrs)
Physicians evaluation of swelling, redness and induration at the site of injection	After each dose

Trial Locations

Locations (5)

Army Hospital R & R; 🇮🇳 Delhi, DELHI, India

Grant Medical College & Sir J. J. group of hospitals; 🇮🇳 Mumbai, MAHARASHTRA, India

R. G. Stone Urological Research Centre; 🇮🇳 Delhi, DELHI, India

Sancheti Institute for Orthopaedics & Rehabilitation; 🇮🇳 Pune, MAHARASHTRA, India

Seth G. S. Medical college and K. E. M Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Army Hospital R & R

🇮🇳Delhi, DELHI, India

DR. COL. T. V. S. P. MURTHY

Principal investigator

tvspmurthy@yahoo.com