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

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ClinicalTrials.gov Identifier: NCT02598102
Recruitment Status : Completed
First Posted : November 5, 2015
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Vilvapathy Senguttuvan Karthikeyan, 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

Condition or disease Intervention/treatment Phase
Pain Drug: Diclofenac sodium Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Preprocedural Diclofenac in Males Undergoing Double J Stent Removal Under Local Anesthesia
Study Start Date : April 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diclofenac sodium
Oral diclofenac 75 mg one hour prior to stent removal
Drug: Diclofenac sodium
Diclofenac for pain relief
Other Name: Voveran

Placebo Comparator: Placebo
Placebo one hour prior to stent removal
Drug: Placebo
Placebo for comparison




Primary Outcome Measures :
  1. Pain [ Time Frame: Intraoperative upto 24 hours postoperative ]
    Pain during stent removal, first void and 24 hours after procedure


Secondary Outcome Measures :
  1. Adverse reactions [ Time Frame: 24 hours ]
    Adverse reactions to diclofenac sodium



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598102


Locations
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India
Institute of Nephro Urology
Bangalore, Karnataka, India, 560002
Sponsors and Collaborators
Institute of Nephro Urology, Bangalore
Investigators
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Principal Investigator: VS Karthikeyan Postgraduate in Urology

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vilvapathy Senguttuvan Karthikeyan, MCh Urology Postgraduate in Urology, Institute of Nephro Urology, Bangalore
ClinicalTrials.gov Identifier: NCT02598102     History of Changes
Other Study ID Numbers: INU/RRC/01/2014-15
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Diclofenac
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action