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OpenTrials
Completed

NCT Number: NCT02598102

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Institute of Nephro Urology

Bangalore, Karnataka, 560002, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diclofenac Sodium

Drug

Diclofenac for pain relief

Other names: Voveran

Placebo

Drug

Placebo for comparison

Primary outcomes

  1. Pain

    Time frame: Intraoperative upto 24 hours postoperative

    Pain during stent removal, first void and 24 hours after procedure

Secondary outcomes

  1. Adverse reactions

    Time frame: 24 hours

    Adverse reactions to diclofenac sodium

Sponsors and collaborators

Lead sponsor

Institute of Nephro Urology, Bangalore

Other Gov

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 5, 2015
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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