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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Diclofenac sodium
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac sodium<br>Oral diclofenac 75 mg one hour prior to stent removal | Drug: Diclofenac sodium<br>* Diclofenac for pain relief<br>* Other names: Voveran;|
| Placebo Comparator: Placebo<br>Placebo one hour prior to stent removal | Drug: Placebo<br>* Placebo for comparison<br>|

What is the study measuring?
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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 |