To determine the efficacy and safety of Inj Diclofenac 75mg/ml given intradeltoid with Injection Diclofenac 75mg/3ml given intragluteal in the management of postoperative pain in obese patients.

A randomized comparative study evaluating efficacy and tolerability of injection Diclofenac sodium 75mg/1ml given intradeltoid versus injection Diclofenac sodium 75mg/3ml given intragluteal in the management of post operative pain in obese patients.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000108

Enrollment

200

Registered

2009-04-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Post Operative Pain

Interventions

Intervention1: Injection Diclofenac sodium 75 mg/ 1 ml: 75 mg given intra-deltoid repeated every 12 hours for 2 days. Control Intervention1: Injection Diclofenac sodium 75 mg/ 3 ml: 75 mg given intra-

Eligibility

Inclusion criteria

Inclusion criteria: Patients in the age group of 18 to 65 years Patients of both sexes Patients with BMI greater or equal to 25 Patients undergoing operative procedures requiring hospitalization for at least 48 hours Patients with moderate to severe pain at baseline VAS 4 to10

Exclusion criteria

Exclusion criteria: 1.Patients below 18 years and above 65 years of age 2.Patients with BMI < or = 25 3.OPD patients/ patients requiring hospitalization less than 48 hours 4.Patients with compromised renal function 5.Pregnant and lactating women 6.Patients with history of bronchial asthma, peptic ulceration, bronchitis 7.Patients with coagulation disorders, especially bleeding disorders 8.Mentally retarded patients 9.Unwilling patients 10.Patients with known hypersensitivity to propylene glycol, diclofenac sodium any other NSAIDs or any component of either of the study formulations 11.Patients with a baseline VAS score of 3 or less than 3

Design outcomes

Primary

Measure	Time frame
Degree of pain relief, as assessed by a 5- point scale by patientsTimepoint: At the end of 1, 4, 8 and 12 hours as compared to basal after each dose.;Degree of pain relief, as assessed by a 5- point scale by patientsTimepoint: At the end of 1, 4, 8 and 12 hours as compared to basal after each dose.;Degree of pain relief, as assessed by a 5- point scale by patientsTimepoint: At the end of 1, 4, 8 and 12 hours as compared to basal after each dose.	—

Measure

Time frame

Degree of pain relief, as assessed by a 5- point scale by patientsTimepoint: At the end of 1, 4, 8 and 12 hours as compared to basal after each dose.;Degree of pain relief, as assessed by a 5- point scale by patientsTimepoint: At the end of 1, 4, 8 and 12 hours as compared to basal after each dose.;Degree of pain relief, as assessed by a 5- point scale by patientsTimepoint: At the end of 1, 4, 8 and 12 hours as compared to basal after each dose.

—

Secondary

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

Countries

India

Contacts

Public ContactDr Vijaya Jaiswal

vijayajaiswal@troikaapharma.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026