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

Institute of Nephro Urology, Bangalore

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Placebo; Drug: Diclofenac sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT02598102

INU/RRC/01/2014-15

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Diclofenac sodium

Experimental group

Description:

Oral diclofenac 75 mg one hour prior to stent removal

Treatment:

Drug: Diclofenac sodium

Placebo

Placebo Comparator group

Description:

Placebo one hour prior to stent removal

Treatment:

Drug: Placebo