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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598102
• Other study ID #: INU/RRC/01/2014-15
• Status: Completed
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2018
• Source: Institute of Nephro Urology, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Diclofenac sodium
Diclofenac for pain relief
• Placebo
Placebo for comparison

Locations

Country	Name	City	State
India	Institute of Nephro Urology	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Nephro Urology, Bangalore

Country where clinical trial is conducted

India, 

References & Publications (1)

Chen YT, Hsiao PJ, Wong WY, Wang CC, Yang SS, Hsieh CH. Randomized double-blind comparison of lidocaine gel and plain lubricating gel in relieving pain during flexible cystoscopy. J Endourol. 2005 Mar;19(2):163-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain during stent removal, first void and 24 hours after procedure	Intraoperative upto 24 hours postoperative
Secondary	Adverse reactions	Adverse reactions to diclofenac sodium	24 hours