Benign Prostate HyperplasiaPhase 4TURPNCT01861041
Low Dose Bupivacaine Spinal for Trans Uretral Prostatectomy.
A Phase 4 study testing Heavy Bupivacaine and Isobaric Bupivacaine in people with Benign Prostate Hyperplasia, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Spinal anesthesia, is used during the transuretheral resection of the prostate.Low dose hyperbaric local anesthetics have been used to enhance the resolution of the spinal block. We compared the efficacy and duration of the spinal block with two different bupivacaine baricities. Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- Benign Prostate Hyperplasia
- What is being tested?
- Heavy Bupivacaine and Isobaric Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2013to Jul 2013
- Phase
- Phase 4
- 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 50 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50-85 years ASA 1-4 BENİGN PROSTAT HYPERPLASİ
Who cannot join
- Allergy of study drugs
- Morbid obesity
- Spinal anesthesia contrindications
- Bleeding dyscrasias
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazit Education and Research Hospital
Ankara, 06610
Murat M Sayin, Ass. Prof, +903125962580, muratsayin@hotmail.com
Reyhan POLAT, Dr
About this study
Official title: Low Dose, Low Concentration Different Baricity Bupivacaine for Transuretral Prostatectomy.
Spinal anesthesia, is used during the transuretheral resection of the prostate.Low dose hyperbaric local anesthetics have been used to enhance the resolution of the spinal block. We compared the efficacy and duration of the spinal block with two different bupivacaine baricities.
- Group I: low dose isobaric group
- GroupII: Low dose hyperbaric group
Read the detailed description
Patients undergoing TURP were randomly allocated into two groups.
- Group I: Received fentanyl 20 µgr (0.4ml),heavy bupivacaine 0.5% (1.5 ml)and normal saline % 0.9 NaCl ( 1.1ml)
- Group II: Received fentanyl 20 µgr (0.4 ml), plain bupivacaine 0.5%(1.5 ml) normal saline 0.9% NaCl (1.1 mL) in total bupivacaine 0.25% (3ml) intrathecally.
Onset and duration of the sensory block, the degree of the motor block, side - effects and perioperative analgesic requirement assesed.
- Conditions
- Benign Prostate Hyperplasia
- Being tested
- Heavy Bupivacaine, Isobaric Bupivacaine
- Keywords
- low dose, different baricity, spinal anesthesia
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy BupivacaineDrug
Also called marcaine heavy
7,5 mg intrathecal hyperbaric bupivacain,
Isobaric BupivacaineDrug
Also called Marcain flakon
7.5 mg intratecal isobaric bupivacain
| Study group | Role | What they receive |
|---|---|---|
| Heavy Bupivacain, Local anesthetic, Amp | Experimental | Heavy bupivacaine 7.5 mg (1.5 ml), 20 microgram fentanyl(0.4 ml), 1.1 ml saline , Total 3 ml Receives: Drug: Heavy Bupivacaine |
| Isobaric spinal, Local anesthetic, Amp | Active comparator | 7,5 mg isobaric bupivacaine, 20 microgram (0.4 ml)fentanyl, 1.1 ml saline, Total 3 ml Receives: Drug: Isobaric Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Block Quality
Sensory block assesment with pinpric test.
Measured: 15 minute after intrathecal injection
Secondary outcomes (1)
Spinal block regression
Sensory block assesment with pinprick test
Measured: 5 minute after arrival at PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Benign Prostate HyperplasiaStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- MURAT M SAYIN, Ass. Prof, Study director, Dispapi yildirim beyazit E R hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861041
- Sponsor's protocol ID
- PROSTAT
- Acronym
- TURP
- Status last verified
- May 2013
- First submitted
- 15 May 2013
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Loubert C, Hallworth S, Fernando R, Columb M, Patel N, Sarang K, Sodhi V. Does the baricity of bupivacaine influence intrathecal spread in the prolonged sitting position before elective cesarean delivery? A prospective randomized controlled study. Anesth Analg. 2011 Oct;113(4):811-7. doi: 10.1213/ANE.0b013e3182288bf2. Epub 2011 Sep 2.
PubMed 21890887Kim SY, Cho JE, Hong JY, Koo BN, Kim JM, Kil HK. Comparison of intrathecal fentanyl and sufentanil in low-dose dilute bupivacaine spinal anaesthesia for transurethral prostatectomy. Br J Anaesth. 2009 Nov;103(5):750-4. doi: 10.1093/bja/aep263. Epub 2009 Sep 28.
PubMed 19797249
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose, Low Concentration Different Baricity Bupivacaine for Transuretral Prostatectomy.
- ClinicalTrials.gov ID
- NCT01861041
- Acronym / sponsor ID
- TURP / PROSTAT
- Conditions
- Benign Prostate Hyperplasia
- Keywords
- low dose, different baricity, spinal anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- May 2013
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 23 May 2013 (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.
Spinal anesthesia, is used during the transuretheral resection of the prostate.Low dose hyperbaric local anesthetics have been used to enhance the resolution of the spinal block. We compared the efficacy and duration of the spinal block with two different bupivacaine baricities.
- Group I: low dose isobaric group
- GroupII: Low dose hyperbaric group
Detailed description
Patients undergoing TURP were randomly allocated into two groups.
- Group I: Received fentanyl 20 µgr (0.4ml),heavy bupivacaine 0.5% (1.5 ml)and normal saline % 0.9 NaCl ( 1.1ml)
- Group II: Received fentanyl 20 µgr (0.4 ml), plain bupivacaine 0.5%(1.5 ml) normal saline 0.9% NaCl (1.1 mL) in total bupivacaine 0.25% (3ml) intrathecally.
Onset and duration of the sensory block, the degree of the motor block, side - effects and perioperative analgesic requirement assesed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy Bupivacain, Local anesthetic, Amp | Experimental | Drug: Heavy BupivacaineHeavy bupivacaine 7.5 mg (1.5 ml), 20 microgram fentanyl(0.4 ml), 1.1 ml saline , Total 3 ml |
| Isobaric spinal, Local anesthetic, Amp | Active comparator | Drug: Isobaric Bupivacaine7,5 mg isobaric bupivacaine, 20 microgram (0.4 ml)fentanyl, 1.1 ml saline, Total 3 ml |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 50-85 years ASA 1-4 BENİGN PROSTAT HYPERPLASİ
Key exclusion criteria (4 listed)
- Allergy of study drugs
- Morbid obesity
- Spinal anesthesia contrindications
- Bleeding dyscrasias
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 |
|---|---|---|
| Heavy BupivacaineAlso: marcaine heavy7,5 mg intrathecal hyperbaric bupivacain, | Drug | Heavy Bupivacain, Local anesthetic, Amp |
| Isobaric BupivacaineAlso: Marcain flakon7.5 mg intratecal isobaric bupivacain | Drug | Isobaric spinal, Local anesthetic, Amp |
Primary outcome
Spinal Block Quality
Time frame: 15 minute after intrathecal injection
Sensory block assesment with pinpric test.
1 secondary outcome
Spinal block regression
Time frame: 5 minute after arrival at PACU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2013.
- Background: PubMed 21890887Loubert C, Hallworth S, Fernando R, Columb M, Patel N, Sarang K, Sodhi V. Does the baricity of bupivacaine influence intrathecal spread in the prolonged sitting position before elective cesarean delivery? A prospective randomized controlled study. Anesth Analg. 2011 Oct;113(4):811-7. doi: 10.1213/ANE.0b013e3182288bf2. Epub 2011 Sep 2.
- Background: PubMed 19797249Kim SY, Cho JE, Hong JY, Koo BN, Kim JM, Kil HK. Comparison of intrathecal fentanyl and sufentanil in low-dose dilute bupivacaine spinal anaesthesia for transurethral prostatectomy. Br J Anaesth. 2009 Nov;103(5):750-4. doi: 10.1093/bja/aep263. Epub 2009 Sep 28.
Related trials for Benign Prostate Hyperplasia
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
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.
Diskapi Yildirim Beyazit Education and Research Hospital
Ankara, Turkey (Türkiye)
MURAT M SAYIN, Ass. Prof study director
Dispapi yildirim beyazit E R hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Heavy Bupivacaine and Isobaric Bupivacaine in people with Benign Prostate Hyperplasia, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 23 May 2013. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Spinal Block Quality (time frame: 15 minute after intrathecal injection). 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 NCT01861041, which also lists 2 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 23 May 2013.