Clinical trial NCT02534623: Postoperative Quality of Recovery After Transurethral Resection of the Bladder
Official title: Postoperative Quality of Recovery After Transurethral Resection of the Bladder: Spinal Versus General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Bladder Neoplasms
Transurethral Resection of the Bladder
Postoperative Recovery
Lead sponsor: General Hospital Zadar
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Recovery 40 (QoR-40)
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative opioid consumption
timeFrame: 24 hours
measure: Postoperative pain measured with visual analogue scale
timeFrame: 1,6 and 24 hours
measure: Patient satisfaction with anesthesia measured with numerical rating scale
timeFrame: 24 hours
Other outcomes:
Locations:
city: Zadar
country: Croatia
facility: General Hospital Zadar
Study officials:
affiliation: General Hospital Zadar
name: Nina Sulen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gornall BF, Myles PS, Smith CL, Burke JA, Leslie K, Pereira MJ, Bost JE, Kluivers KB, Nilsson UG, Tanaka Y, Forbes A. Measurement of quality of recovery using the QoR-40: a quantitative systematic review. Br J Anaesth. 2013 Aug;111(2):161-9. doi: 10.1093/bja/aet014. Epub 2013 Mar 6.
citation: Catro-Alves LJ, De Azevedo VL, De Freitas Braga TF, Goncalves AC, De Oliveira GS Jr. The effect of neuraxial versus general anesthesia techniques on postoperative quality of recovery and analgesia after abdominal hysterectomy: a prospective, randomized, controlled trial. Anesth Analg. 2011 Dec;113(6):1480-6. doi: 10.1213/ANE.0b013e3182334d8b. Epub 2011 Sep 16.
citation: Barbosa FT, Castro AA. Neuraxial anesthesia versus general anesthesia for urological surgery: systematic review. Sao Paulo Med J. 2013;131(3):179-86. doi: 10.1590/1516-3180.2013.1313535.
citation: Tyritzis SI, Stravodimos KG, Vasileiou I, Fotopoulou G, Koritsiadis G, Migdalis V, Michalakis A, Constantinides CA. Spinal versus General Anaesthesia in Postoperative Pain Management during Transurethral Procedures. ISRN Urol. 2011;2011:895874. doi: 10.5402/2011/895874. Epub 2011 Jul 12.