Postoperative Quality of Recovery After Transurethral Resection of the Bladder

NCT ID: NCT02534623

Last Updated: 2015-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Urinary Bladder Neoplasms Transurethral Resection of the Bladder Postoperative Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Spinal anesthesia

Transurethral resection of the bladder performed under spinal anesthesia.

Group Type ACTIVE_COMPARATOR

Spinal anesthesia

Intervention Type PROCEDURE

bupivacaine

Intervention Type DRUG

fentanyl

Intervention Type DRUG

General anesthesia

Transurethral resection of the bladder performed under general anesthesia.

Group Type ACTIVE_COMPARATOR

General anesthesia

Intervention Type PROCEDURE

fentanyl

Intervention Type DRUG

propofol

Intervention Type DRUG

sevoflurane

Intervention Type DRUG

Interventions

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Spinal anesthesia

Intervention Type PROCEDURE

General anesthesia

Intervention Type PROCEDURE

bupivacaine

Intervention Type DRUG

fentanyl

Intervention Type DRUG

propofol

Intervention Type DRUG

sevoflurane

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital Zadar

OTHER

Sponsor Role lead

Responsible Party

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Nina Sulen

Anesthesiology and Intensive Medicine Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nina Sulen, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital Zadar

Locations

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General Hospital Zadar

Zadar, , Croatia

Site Status

Countries

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Croatia

Facility Contacts

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Nina Sulen, MD

Role: primary

0038598738734

Tatjana Simurina, MD, PhD

Role: backup

0038598331865

References

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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.

Reference Type BACKGROUND
PMID: 23471753 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21926374 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23903267 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22084807 (View on PubMed)

Other Identifiers

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GHZ trial 001

Identifier Type: -

Identifier Source: org_study_id

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