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

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501525
• Other study ID #: SU-RIRS-UAS-03
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: May 2016

Study information

• Verified date: November 2019
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Urolithiasis

Intervention

Device:
• RIRS with ureteral access sheath
Ureteral access sheath will be used during RIRS.
• RIRS without ureteral access sheath
Ureteral access sheath will not be used during RIRS.

Locations

Country	Name	City	State
Turkey	Selcuk University, School of Medicine, Department of Urology	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View Citation

Cepeda M, Amón JH, Mainez JA, Rodríguez V, Alonso D, Martínez-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. — View Citation

Kourambas J, Byrne RR, Preminger GM. Does a ureteral access sheath facilitate ureteroscopy? J Urol. 2001 Mar;165(3):789-93. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Stern JM, Yiee J, Park S. Safety and efficacy of ureteral access sheaths. J Endourol. 2007 Feb;21(2):119-23. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)