Postoperative Quality of Recovery After Transurethral Resection of the Bladder

Urinary Bladder Neoplasms Clinical Trial

Official title:

Postoperative Quality of Recovery After Transurethral Resection of the Bladder: Spinal Versus General Anesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02534623
• Other study ID #: GHZ trial 001
• Status: Not yet recruiting
• Phase: N/A
• First received: August 15, 2015
• Last updated: August 26, 2015
• Start date: September 2015
• Est. completion date: November 2016

Study information

• Verified date: August 2015
• Source: General Hospital Zadar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ministry of Health and Social Care
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Recovery
• Transurethral Resection of the Bladder
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Spinal anesthesia

• General anesthesia

Drug:
• bupivacaine

• fentanyl

• propofol

• sevoflurane

Locations

Country	Name	City	State
Croatia	General Hospital Zadar	Zadar

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital Zadar

Country where clinical trial is conducted

Croatia, 

References & Publications (4)

Barbosa FT, Castro AA. Neuraxial anesthesia versus general anesthesia for urological surgery: systematic review. Sao Paulo Med J. 2013;131(3):179-86. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Recovery 40 (QoR-40)	Quality of Recovery 40 questionnaire at 24 hours	24 hours	No
Secondary	Postoperative opioid consumption	Postoperative opioid consumption over 24 hours	24 hours	No
Secondary	Postoperative pain measured with visual analogue scale	Postoperative pain measured with visual analogue scale at 1,6 and 24 hours	1,6 and 24 hours	No
Secondary	Patient satisfaction with anesthesia measured with numerical rating scale	Overall patient satisfaction with anesthesia measured with numerical rating scale	24 hours	No