Postoperative Quality of Recovery After Transurethral Resection of the Bladder

Not Applicable

• Conditions: Urinary Bladder Neoplasms; Transurethral Resection of the Bladder; Postoperative Recovery
• Interventions: Procedure: General anesthesia; Procedure: Spinal anesthesia; Drug: fentanyl; Drug: bupivacaine; Drug: propofol; Drug: sevoflurane

• Registration Number: NCT02534623
• Lead Sponsor: General Hospital Zadar

Brief Summary

Transurethral resection of the bladder (TURB) is often performed as an outpatient procedure so high-quality postoperative recovery is particularly important. The aim of this study is to compare postoperative quality of recovery after spinal anesthesia (SA) and general anesthesia (GA) for transurethral resection of the bladder.

Detailed Description

After written informed consent is obtained seventy patients aged 18-80 years, ASA (American Society of Anesthesiologists) physical status class I-III scheduled for TURB will be randomly assigned to either spinal anesthesia or general anesthesia. Spinal anesthesia will be performed with 12.5 mg of bupivacaine mixed with 25 mcg of fentanyl. General anesthesia will be performed with propofol and fentanyl and maintained with sevoflurane, without use of neuromuscular blocking agents. Quality of Recovery 40 questionnaire (QoR-40) administered before and 24 hours after surgery will be used for assessment of postoperative recovery.

Study Timeline

• Status Verified: 2015-08
• Study First Submitted: 2015-08-15
• Study First Submitted QC: 2015-08-26
• Last Update Submitted: 2015-08-26
• Study First Posted: 2015-08-27
• Last Update Posted: 2015-08-27
• Study Start: 2015-09
• Primary Completion: 2016-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Transurethral resection of the bladder
• Age 18 to 80 years
• ASA I-III

Exclusion Criteria

• Contraindications for spinal anesthesia
• Chronic pain with use of opioids in the last week
• Psychiatric disorders
• Allergy to medications used in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia	General anesthesia	Transurethral resection of the bladder performed under general anesthesia.
General anesthesia	fentanyl	Transurethral resection of the bladder performed under general anesthesia.
General anesthesia	propofol	Transurethral resection of the bladder performed under general anesthesia.
General anesthesia	sevoflurane	Transurethral resection of the bladder performed under general anesthesia.
Spinal anesthesia	Spinal anesthesia	Transurethral resection of the bladder performed under spinal anesthesia.
Spinal anesthesia	bupivacaine	Transurethral resection of the bladder performed under spinal anesthesia.
Spinal anesthesia	fentanyl	Transurethral resection of the bladder performed under spinal anesthesia.

Primary Outcome Measures

Name	Time	Method
Quality of Recovery 40 (QoR-40)	24 hours	Quality of Recovery 40 questionnaire at 24 hours

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with anesthesia measured with numerical rating scale	24 hours	Overall patient satisfaction with anesthesia measured with numerical rating scale
Postoperative opioid consumption	24 hours	Postoperative opioid consumption over 24 hours
Postoperative pain measured with visual analogue scale	1,6 and 24 hours	Postoperative pain measured with visual analogue scale at 1,6 and 24 hours

Trial Locations

Locations (1)

General Hospital Zadar; 🇭🇷 Zadar, Croatia