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

August 27, 2018 updated by: Vilvapathy Senguttuvan Karthikeyan, Institute of Nephro Urology, Bangalore
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Intraoperative upto 24 hours postoperative
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
Time Frame: 24 hours
Adverse reactions to diclofenac sodium
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Nephro Urology, Bangalore

Investigators

  • Principal Investigator: VS Karthikeyan, Postgraduate in Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • INU/RRC/01/2014-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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