Effect of Ureteral Access Sheath Use on Postoperative Pain Level in Patients Undergoing RIRS

Not Applicable

Completed

• Conditions: Urolithiasis
• Interventions: Device: RIRS without ureteral access sheath; Device: RIRS with ureteral access sheath

• Registration Number: NCT02501525
• Lead Sponsor: Selcuk University

Brief Summary

This study will include patients aged between 18 and 70 who will undergo retrograde intrarenal surgery (RIRS) due to renal stone(s). A total of 80 patients (male or female) will be recruited, and will be randomized into 2 groups consisting of 40 patients in each group. The first group of patients will undergo RIRS with a ureteral access sheath (UAS) positioned prior to surgery; and the second group will undergo RIRS without UAS. As use of UAS decreases the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether using UAS or not affects the level of pain felt by patients in the postoperative period.

Detailed Description

The level of pain of the patients in both groups will be evaluated by using visual analog score (VAS) and verbal rating score (VRS) in the postoperative 0 min (the moment patients gets consciousness after he/she wakes up from general anesthesia), 10th min, 30th min, 60th min and 120th min.

Study Timeline

• Study First Submitted: 2015-07-11
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-17
• Study Start: 2015-08
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Being between 18-70 years old
• Having an indication of retrograde infrarenal surgery (RIRS) due to kidney stone

Exclusion Criteria

• Patients with uncontrolled diabetes mellitus and diabetic nephropathy
• Patients with blood pressure > 140/80 mmHg despite regular use of antihypertensive agent(s)
• Patients with chronic kidney failure who need dialysis
• Patients who have had prerenal, renal or postrenal acute kidney failure 3 months or much earlier
• Patients who have had pyelonephritis 3 months or much earlier
• Patients younger than 18 years or older than 70 years
• Patients who have undergone a kidney surgery within the last 3 months and have abnormal kidney function tests
• Patients with a concomitant ureter stone who will undergo an endoscopic ureter stone treatment at the same session
• Patients using any kind of medication that can affect his/her perception of pain

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UAS (-)	RIRS without ureteral access sheath	RIRS without ureteral access sheath: A ureteral access sheath (UAS) will not be positioned into the ureter of the patient prior to the insertion of the flexible ureterorenoscope (RIRS).
UAS (+)	RIRS with ureteral access sheath	RIRS with ureteral access sheath: A ureteral access sheath (UAS) will be positioned into the ureter of the patient prior to the insertion of the flexible ureterorenoscope (RIRS).

Primary Outcome Measures

Name	Time	Method
Postoperative pain level	Within the first 2 hours after the surgery (RIRS)	Postoperative pain levels of the patients in both groups will be evaluated by using verbal rating score (VRS).

Trial Locations

Locations (1)

Selcuk University, School of Medicine, Department of Urology; 🇹🇷 Konya, Turkey