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

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Diclofenac sodium; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560002
      • Institute of Nephro Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diclofenac sodium; Oral diclofenac 75 mg one hour prior to stent removal	Drug: Diclofenac sodium; Diclofenac for pain relief; Other Names: Voveran
Placebo Comparator: Placebo; Placebo one hour prior to stent removal	Drug: Placebo; Placebo for comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain during stent removal, first void and 24 hours after procedure	Intraoperative upto 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reactions	Adverse reactions to diclofenac sodium	24 hours

Collaborators and Investigators

• Sponsor: Institute of Nephro Urology, Bangalore
• Investigators: Principal Investigator: VS Karthikeyan, Postgraduate in Urology

Publications and helpful links

General Publications

• Chen YT, Hsiao PJ, Wong WY, Wang CC, Yang SS, Hsieh CH. Randomized double-blind comparison of lidocaine gel and plain lubricating gel in relieving pain during flexible cystoscopy. J Endourol. 2005 Mar;19(2):163-6. doi: 10.1089/end.2005.19.163.
• Karthikeyan VS, Keshavamurthy R, Mallya A, Chikka Moga Siddaiah M, Kumar S, Chandrashekar CR. Efficacy of preprocedural diclofenac in men undergoing double J stent removal under local anesthesia: A double-blind, randomized control trial. Indian J Urol. 2017 Jan-Mar;33(1):53-57. doi: 10.4103/0970-1591.194783.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: November 4, 2015
• First Posted (Estimate): November 5, 2015

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: INU/RRC/01/2014-15