Pain
Conditions
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
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.
Interventions
DRUGDiclofenac sodium
Diclofenac for pain relief
DRUGPlacebo
Placebo for comparison
Sponsors
Institute of Nephro Urology, Bangalore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | Intraoperative upto 24 hours postoperative | Pain during stent removal, first void and 24 hours after procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse reactions | 24 hours | Adverse reactions to diclofenac sodium |
Countries
India
Outcome results
None listed