Postoperative Quality of Recovery After Transurethral Resection of the Bladder

August 26, 2015 updated by: Nina Sulen, General Hospital Zadar

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zadar, Croatia, 23000
        • General Hospital Zadar
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nina Sulen, MD
        • Sub-Investigator:
          • Tatjana Simurina, MD,PhD
        • Sub-Investigator:
          • Tomislav Soric, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Spinal anesthesia
Transurethral resection of the bladder performed under spinal anesthesia.
Drug: fentanyl
Drug: bupivacaine
Procedure: Spinal anesthesia
Active Comparator: General anesthesia
Transurethral resection of the bladder performed under general anesthesia.
Drug: fentanyl
Drug: sevoflurane
Drug: propofol
Procedure: General anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery 40 (QoR-40)
Time Frame: 24 hours
Quality of Recovery 40 questionnaire at 24 hours
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital Zadar

Investigators

  • Principal Investigator: Nina Sulen, MD, General Hospital Zadar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

August 15, 2015

First Submitted That Met QC Criteria

August 26, 2015

First Posted (Estimate)

August 27, 2015

Study Record Updates

Last Update Posted (Estimate)

August 27, 2015

Last Update Submitted That Met QC Criteria

August 26, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHZ trial 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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