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

Effect of Ureteral Access Sheath Use on Postoperative Pain Level in Patients Undergoing Retrograde Intrarenal Surgery (RIRS)

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.

Study Overview

• Status: Completed
• Conditions: Urolithiasis
• Intervention / Treatment: Device: RIRS with ureteral access sheath; Device: RIRS without ureteral access sheath

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42075
    • Selcuk University, School of Medicine, Department of Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: UAS (+); 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).	Device: RIRS with ureteral access sheath; Ureteral access sheath will be used during RIRS.
Experimental: UAS (-); 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).	Device: RIRS without ureteral access sheath; Ureteral access sheath will not be used during RIRS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain level	Postoperative pain levels of the patients in both groups will be evaluated by using visual analog score (VAS).	Within the first 2 hours after the surgery (RIRS)
Postoperative pain level	Postoperative pain levels of the patients in both groups will be evaluated by using verbal rating score (VRS).	Within the first 2 hours after the surgery (RIRS)

Collaborators and Investigators

• Sponsor: Selcuk University

Publications and helpful links

General Publications

• L'esperance JO, Ekeruo WO, Scales CD Jr, Marguet CG, Springhart WP, Maloney ME, Albala DM, Preminger GM. Effect of ureteral access sheath on stone-free rates in patients undergoing ureteroscopic management of renal calculi. Urology. 2005 Aug;66(2):252-5. doi: 10.1016/j.urology.2005.03.019.
• Lallas CD, Auge BK, Raj GV, Santa-Cruz R, Madden JF, Preminger GM. Laser Doppler flowmetric determination of ureteral blood flow after ureteral access sheath placement. J Endourol. 2002 Oct;16(8):583-90. doi: 10.1089/089277902320913288.
• Resorlu B, Unsal A, Gulec H, Oztuna D. A new scoring system for predicting stone-free rate after retrograde intrarenal surgery: the "resorlu-unsal stone score". Urology. 2012 Sep;80(3):512-8. doi: 10.1016/j.urology.2012.02.072. Epub 2012 Jul 26.
• Cepeda M, Amon JH, Mainez JA, Rodriguez V, Alonso D, Martinez-Sagarra JM. Flexible ureteroscopy for renal stones. Actas Urol Esp. 2014 Nov;38(9):571-5. doi: 10.1016/j.acuro.2014.03.014. Epub 2014 Jun 2. English, Spanish.
• Auge BK, Pietrow PK, Lallas CD, Raj GV, Santa-Cruz RW, Preminger GM. Ureteral access sheath provides protection against elevated renal pressures during routine flexible ureteroscopic stone manipulation. J Endourol. 2004 Feb;18(1):33-6. doi: 10.1089/089277904322836631.
• Kourambas J, Byrne RR, Preminger GM. Does a ureteral access sheath facilitate ureteroscopy? J Urol. 2001 Mar;165(3):789-93.
• Stern JM, Yiee J, Park S. Safety and efficacy of ureteral access sheaths. J Endourol. 2007 Feb;21(2):119-23. doi: 10.1089/end.2007.9997.
• Torricelli FC, De S, Hinck B, Noble M, Monga M. Flexible ureteroscopy with a ureteral access sheath: when to stent? Urology. 2014 Feb;83(2):278-81. doi: 10.1016/j.urology.2013.10.002. Epub 2013 Nov 12.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: July 11, 2015
• First Submitted That Met QC Criteria: July 15, 2015
• First Posted (Estimate): July 17, 2015

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: pain; retrograde intrarenal surgery; renal stone; ureteral access sheath
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Urolithiasis
• Other Study ID Numbers: SU-RIRS-UAS-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No