NCT02534623

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

1.2 years

First QC Date

August 15, 2015

Last Update Submit

August 26, 2015

Conditions

Urinary Bladder NeoplasmsTransurethral Resection of the BladderPostoperative Recovery

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery 40 (QoR-40)

    Quality of Recovery 40 questionnaire at 24 hours

    24 hours

Secondary Outcomes (3)

  • Postoperative opioid consumption

    24 hours

  • Postoperative pain measured with visual analogue scale

    1,6 and 24 hours

  • Patient satisfaction with anesthesia measured with numerical rating scale

    24 hours

Study Arms (2)

Spinal anesthesia

ACTIVE COMPARATOR

Transurethral resection of the bladder performed under spinal anesthesia.

Procedure: Spinal anesthesiaDrug: bupivacaineDrug: fentanyl

General anesthesia

ACTIVE COMPARATOR

Transurethral resection of the bladder performed under general anesthesia.

Procedure: General anesthesiaDrug: fentanylDrug: propofolDrug: sevoflurane

Interventions

Spinal anesthesiaPROCEDURE
Spinal anesthesia
General anesthesiaPROCEDURE
General anesthesia
bupivacaineDRUG
Spinal anesthesia
fentanylDRUG
General anesthesiaSpinal anesthesia
propofolDRUG
General anesthesia
sevofluraneDRUG
General anesthesia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Zadar

Zadar, 23000, Croatia

Location

Related Publications (4)

  • 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.

    PMID: 23471753BACKGROUND

  • 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.

    PMID: 21926374BACKGROUND

  • 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.

    PMID: 23903267BACKGROUND

  • 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.

    PMID: 22084807BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Anesthesia, SpinalAnesthesia, GeneralBupivacaineFentanylPropofolSevoflurane

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Nina Sulen, MD

    General Hospital Zadar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Intensive Medicine Specialist

Study Record Dates

First Submitted

August 15, 2015

First Posted

August 27, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

August 27, 2015

Record last verified: 2015-08

Locations

CR(1)