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Postoperative Quality of Recovery After Transurethral Resection of the Bladder

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Spinal anesthesia
General anesthesia
bupivacaine
fentanyl
propofol
sevoflurane
Sponsored by
General Hospital Zadar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder Neoplasms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital Zadar

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Spinal anesthesia

General anesthesia

Arm Description

Transurethral resection of the bladder performed under spinal anesthesia.

Transurethral resection of the bladder performed under general anesthesia.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 15, 2015
Last Updated
August 26, 2015
Sponsor
General Hospital Zadar
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1. Study Identification

Unique Protocol Identification Number
NCT02534623
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital Zadar

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms, Transurethral Resection of the Bladder, Postoperative Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal anesthesia
Arm Type
Active Comparator
Arm Description
Transurethral resection of the bladder performed under spinal anesthesia.
Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
Transurethral resection of the bladder performed under general anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Spinal anesthesia
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Intervention Type
Drug
Intervention Name(s)
fentanyl
Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Type
Drug
Intervention Name(s)
sevoflurane
Primary Outcome Measure Information:
Title
Quality of Recovery 40 (QoR-40)
Description
Quality of Recovery 40 questionnaire at 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
Postoperative opioid consumption over 24 hours
Time Frame
24 hours
Title
Postoperative pain measured with visual analogue scale
Description
Postoperative pain measured with visual analogue scale at 1,6 and 24 hours
Time Frame
1,6 and 24 hours
Title
Patient satisfaction with anesthesia measured with numerical rating scale
Description
Overall patient satisfaction with anesthesia measured with numerical rating scale
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Sulen, MD
Organizational Affiliation
General Hospital Zadar
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital Zadar
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina Sulen, MD
Phone
0038598738734
Email
nina.sulen@zd.t-com.hr
First Name & Middle Initial & Last Name & Degree
Tatjana Simurina, MD, PhD
Phone
0038598331865
Email
tatjana.simurina@gmail.com
First Name & Middle Initial & Last Name & Degree
Nina Sulen, MD
First Name & Middle Initial & Last Name & Degree
Tatjana Simurina, MD,PhD
First Name & Middle Initial & Last Name & Degree
Tomislav Soric, MD,PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
23471753
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.
Results Reference
background
PubMed Identifier
21926374
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.
Results Reference
background
PubMed Identifier
23903267
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.
Results Reference
background
PubMed Identifier
22084807
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.
Results Reference
background

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Postoperative Quality of Recovery After Transurethral Resection of the Bladder

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