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NCT Number: NCT02501525

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

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Key information

Conditions

Urolithiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University, School of Medicine, Department of Urology

Konya, 42075, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RIRS with ureteral access sheath

Device

Ureteral access sheath will be used during RIRS.

RIRS without ureteral access sheath

Device

Ureteral access sheath will not be used during RIRS.

Primary outcomes

  1. Postoperative pain level

    Time frame: Within the first 2 hours after the surgery (RIRS)

    Postoperative pain levels of the patients in both groups will be evaluated by using visual analog score (VAS).

  2. Postoperative pain level

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 17, 2015
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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