Urinary Bladder NeoplasmsNCT02534623
Postoperative Quality of Recovery After Transurethral Resection of the Bladder
A study testing Spinal anesthesia, General anesthesia and bupivacaine in people with Urinary Bladder Neoplasms and Transurethral Resection of the Bladder, run by General Hospital Zadar at 1 site in Croatia.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urinary Bladder Neoplasms, Transurethral Resection of the Bladder, Postoperative Recovery
- What is being tested?
- Spinal anesthesia, General anesthesia and bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCroatia
- Study dates
- Sep 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Transurethral resection of the bladder
- Age 18 to 80 years
- ASA I-III
Who cannot join
- Contraindications for spinal anesthesia
- Chronic pain with use of opioids in the last week
- Psychiatric disorders
- Allergy to medications used in the study
Trial locations and contacts
1 site in 1 country.
Croatia1 site
General Hospital Zadar
Zadar, 23000
Nina Sulen, MD, 0038598738734, nina.sulen@zd.t-com.hr
Tatjana Simurina, MD, PhD, 0038598331865, tatjana.simurina@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Spinal anesthesia, General anesthesia, bupivacaine, fentanyl, propofol
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaProcedure or surgery
General anesthesiaProcedure or surgery
bupivacaineDrug
fentanylDrug
propofolDrug
sevofluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| Spinal anesthesia | Active comparator | Transurethral resection of the bladder performed under spinal anesthesia. Receives: Procedure: Spinal anesthesia; Drug: bupivacaine; Drug: fentanyl |
| General anesthesia | Active comparator | Transurethral resection of the bladder performed under general anesthesia. Receives: Procedure: General anesthesia; Drug: fentanyl; Drug: propofol; Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery 40 (QoR-40)
Quality of Recovery 40 questionnaire at 24 hours
Measured: 24 hours
Secondary outcomes (3)
Postoperative opioid consumption
Postoperative opioid consumption over 24 hours
Measured: 24 hours
Postoperative pain measured with visual analogue scale
Postoperative pain measured with visual analogue scale at 1,6 and 24 hours
Measured: 1,6 and 24 hours
Patient satisfaction with anesthesia measured with numerical rating scale
Overall patient satisfaction with anesthesia measured with numerical rating scale
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital Zadar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Sulen, General Hospital Zadar
- Investigators
- Nina Sulen, MD, Principal investigator, General Hospital Zadar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534623
- Sponsor's protocol ID
- GHZ trial 001
- Status last verified
- Aug 2015
- First submitted
- 15 Aug 2015
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23471753Catro-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.
PubMed 21926374Barbosa 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.
PubMed 23903267Tyritzis 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.
PubMed 22084807
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Quality of Recovery After Transurethral Resection of the Bladder: Spinal Versus General Anesthesia
- ClinicalTrials.gov ID
- NCT02534623
- Acronym / sponsor ID
- GHZ trial 001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- General Hospital ZadarUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia | Active comparator | Procedure: Spinal anesthesia, Drug: bupivacaine, Drug: fentanylTransurethral resection of the bladder performed under spinal anesthesia. |
| General anesthesia | Active comparator | Procedure: General anesthesia, Drug: fentanyl, Drug: propofol, Drug: sevofluraneTransurethral resection of the bladder performed under general anesthesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Transurethral resection of the bladder
- Age 18 to 80 years
- ASA I-III
Key exclusion criteria (4 listed)
- Contraindications for spinal anesthesia
- Chronic pain with use of opioids in the last week
- Psychiatric disorders
- Allergy to medications used in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesia | Procedure or surgery | Spinal anesthesia |
| General anesthesia | Procedure or surgery | General anesthesia |
| bupivacaine | Drug | Spinal anesthesia |
| fentanyl | Drug | General anesthesia, Spinal anesthesia |
| propofol | Drug | General anesthesia |
| sevoflurane | Drug | General anesthesia |
Primary outcome
Quality of Recovery 40 (QoR-40)
Time frame: 24 hours
Quality of Recovery 40 questionnaire at 24 hours
3 secondary outcomes
Postoperative opioid consumption
Time frame: 24 hours
Postoperative pain measured with visual analogue scale
Time frame: 1,6 and 24 hours
Patient satisfaction with anesthesia measured with numerical rating scale
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
- Background: PubMed 23471753Gornall 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.
- Background: PubMed 21926374Catro-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.
- Background: PubMed 23903267Barbosa 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.
- Background: PubMed 22084807Tyritzis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Sulen, MD principal investigator
General Hospital Zadar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anesthesia, General anesthesia and bupivacaine in people with Urinary Bladder Neoplasms and Transurethral Resection of the Bladder, run by General Hospital Zadar at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery 40 (QoR-40) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02534623, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2015.