Efficacy of Preprocedural Diclofenac in Males Undergoing Double J Stent Removal Under Local Anesthesia

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Diclofenac sodium

• Registration Number: NCT02598102
• Lead Sponsor: Institute of Nephro Urology, Bangalore

Brief Summary

Double J (DJ) stents are placed following upper urinary tract surgeries. DJ stents are usually removed under local anesthesia using rigid cystoscope. Patients experience a lot of pain during this procedure and also continue to have discomfort during voiding for few days. The use of lignocaine jelly during this procedure is not very effective. Use of diclofenac suppository during flexible cystoscopy has been proven to be effective. This study was done to assess the effect of oral diclofenac in pain relief in patients undergoing DJ stent removal by rigid cystoscopy when compared to placebo and to assess its safety in these patients

Detailed Description

Consecutive consenting male patients undergoing DJ stent removal under local anesthesia during 2014-15 were enrolled. Patients were randomized to receive 75 mg oral diclofenac or placebo 1 hour prior to procedure by double blind randomization. Intraurethral 2% lignocaine jelly (25 ml) was used in both groups. Pain during rigid cystoscopy, pain at first void and at 24 hours after cystoscopy was assessed using visual analogue scale \[VAS\] (0 to 100). Adverse reactions to diclofenac and episodes of acute urinary retention, if any, were assessed.

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

All consecutive consenting male patients aged more than 18 years, undergoing DJ stent removal under local anesthesia (2% Lignocaine jelly) during the study period will be included.

Exclusion Criteria

• Patients unable to understand visual analogue pain score
• Age < 18 years
• Presence of Lower Urinary Tract Symptoms prior to surgery
• Presence of prostatitis or urethral stricture during cystoscopy
• Patients with renal failure (Serum creatinine > 1.3 mg/dl)
• Patients on concomitant nephrotoxic drugs
• Patients with history of peptic ulcer or upper gastrointestinal bleed or upper abdominal surgeries
• Loss to follow up at 24 hours following DJ stent removal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo one hour prior to stent removal
Diclofenac sodium	Diclofenac sodium	Oral diclofenac 75 mg one hour prior to stent removal

Primary Outcome Measures

Name	Time	Method
Pain	Intraoperative upto 24 hours postoperative	Pain during stent removal, first void and 24 hours after procedure

Secondary Outcome Measures

Name	Time	Method
Adverse reactions	24 hours	Adverse reactions to diclofenac sodium

Trial Locations

Locations (1)

Institute of Nephro Urology; 🇮🇳 Bangalore, Karnataka, India