Benign Prostate HyperplasiaPhase 4NCT01675895
Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration
A Phase 4 study testing Levobupivacaine lidocaine spinal anesthesia and levobupivacaine Spinal anesthesia in people with Benign Prostate Hyperplasia, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The main objective was to test the hypothesis that adding lidocaine to hyperbaric levobupivacaine could change the duration of levobupivacaine spinal block. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Benign Prostate Hyperplasia
- What is being tested?
- Levobupivacaine lidocaine spinal anesthesia and levobupivacaine Spinal anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2009to Jul 2011
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective transurethral resection of the prostate (TUR-P)
Who cannot join
- patients with contraindications for spinal anesthesia,
- known sensitivity to the study drugs,
- emergency cases, and
- patients who refused spinal anaesthesia were excluded
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital
Ankara, 06110
About this study
Official title: Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration: Randomized Controlled Trial
The main objective was to test the hypothesis that adding lidocaine to hyperbaric levobupivacaine could change the duration of levobupivacaine spinal block.
Read the detailed description
A satisfactory spinal anaesthesia requires both a fast onset and proper duration at the same time. Transurethral resection of the prostate (TUR-P) is a surgery of medium duration. The addition of lidocaine to hyperbaric bupivacaine shortens the duration of bupivacaine spinal block and therefore provides more rapid recovery. This property of lidocaine is not verified with other local anesthetics. Levobupivacaine is a S-enantiomer of racemic bupivacaine and is a long acting local anesthetic.The aim of this prospective randomized controlled study was to investigate this effect of lidocaine, with a local anesthetic other than bupivacaine. It was hypothesized that the duration of the intrathecal block could change when performed with hyperbaric levobupivacaine mixed with low dose lidocaine and this technique could be consistent for the duration of TUR-P surgery. Participants will be followed on the day of surgery for primary and secondary outcome measures and 3 days postoperatively for complications (TNS).
- Conditions
- Benign Prostate Hyperplasia
- Being tested
- Levobupivacaine lidocaine spinal anesthesia, levobupivacaine Spinal anesthesia
- Keywords
- Hyperbaric Levobupivacaine, İntrathecal, Lidocaine, TUR-P
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobupivacaine lidocaine spinal anesthesiaDrug
Also called Chirocaine, Lidocaine
Spinal anesthesia
levobupivacaine Spinal anesthesiaDrug
Also called Chirocaine
spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group Levobupivacaine lidocaine | Experimental | Group Levobupivacaine lidocaine Spinal anesthesia with 1.5 ml hyperbaric levobupivacaine (6.75 mg) + 0.3 ml 2 % lidocaine Receives: Drug: Levobupivacaine lidocaine spinal anesthesia |
| Group Control | Active comparator | Group Control levobupivacaine spinal anesthesia with levobupivacaine (6.75 mg) + saline Receives: Drug: levobupivacaine Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of the spinal block (S1 regression of the block)
the time between the intrathecal injection and sensorial block regression to S1 dermatome, measured in minutes
Measured: participanta will be followed on the operation day
Secondary outcomes (1)
postoperative care unit stay
the time between the patient entered the PACU and left the PACU (when the sensorial block was regressed to S1 dermatome and the patient fulfilled an Aldrete score higher or equal to 9), measured in minutes
Measured: participants will be followed on the operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startJul 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
- Investigators
- Taylan Akkaya, MD, Study director, Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675895
- Sponsor's protocol ID
- DİLEKLEVOBUPİVACAİNE
- Status last verified
- Dec 2012
- First submitted
- 24 Aug 2012
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee SJ, Bai SJ, Lee JS, Kim WO, Shin YS, Lee KY. The duration of intrathecal bupivacaine mixed with lidocaine. Anesth Analg. 2008 Sep;107(3):824-7. doi: 10.1213/ane.0b013e3181806149.
PubMed 18713891
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01675895
- Acronym / sponsor ID
- DİLEKLEVOBUPİVACAİNE
- Conditions
- Benign Prostate Hyperplasia
- Keywords
- Hyperbaric Levobupivacaine, İntrathecal, Lidocaine, TUR-P
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 30 Aug 2012 (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.
The main objective was to test the hypothesis that adding lidocaine to hyperbaric levobupivacaine could change the duration of levobupivacaine spinal block.
Detailed description
A satisfactory spinal anaesthesia requires both a fast onset and proper duration at the same time. Transurethral resection of the prostate (TUR-P) is a surgery of medium duration. The addition of lidocaine to hyperbaric bupivacaine shortens the duration of bupivacaine spinal block and therefore provides more rapid recovery. This property of lidocaine is not verified with other local anesthetics. Levobupivacaine is a S-enantiomer of racemic bupivacaine and is a long acting local anesthetic.The aim of this prospective randomized controlled study was to investigate this effect of lidocaine, with a local anesthetic other than bupivacaine. It was hypothesized that the duration of the intrathecal block could change when performed with hyperbaric levobupivacaine mixed with low dose lidocaine and this technique could be consistent for the duration of TUR-P surgery. Participants will be followed on the day of surgery for primary and secondary outcome measures and 3 days postoperatively for complications (TNS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Levobupivacaine lidocaine | Experimental | Drug: Levobupivacaine lidocaine spinal anesthesiaGroup Levobupivacaine lidocaine Spinal anesthesia with 1.5 ml hyperbaric levobupivacaine (6.75 mg) + 0.3 ml 2 % lidocaine |
| Group Control | Active comparator | Drug: levobupivacaine Spinal anesthesiaGroup Control levobupivacaine spinal anesthesia with levobupivacaine (6.75 mg) + saline |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective transurethral resection of the prostate (TUR-P)
Key exclusion criteria (4 listed)
- patients with contraindications for spinal anesthesia,
- known sensitivity to the study drugs,
- emergency cases, and
- patients who refused spinal anaesthesia were excluded
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 |
|---|---|---|
| Levobupivacaine lidocaine spinal anesthesiaAlso: Chirocaine, LidocaineSpinal anesthesia | Drug | Group Levobupivacaine lidocaine |
| levobupivacaine Spinal anesthesiaAlso: Chirocainespinal anesthesia | Drug | Group Control |
Primary outcome
The duration of the spinal block (S1 regression of the block)
Time frame: participanta will be followed on the operation day
the time between the intrathecal injection and sensorial block regression to S1 dermatome, measured in minutes
1 secondary outcome
postoperative care unit stay
Time frame: participants will be followed on the operation day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
- Background: PubMed 18713891Lee SJ, Bai SJ, Lee JS, Kim WO, Shin YS, Lee KY. The duration of intrathecal bupivacaine mixed with lidocaine. Anesth Analg. 2008 Sep;107(3):824-7. doi: 10.1213/ane.0b013e3181806149.
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.
Taylan Akkaya, MD study director
Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.
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 Levobupivacaine lidocaine spinal anesthesia and levobupivacaine Spinal anesthesia in people with Benign Prostate Hyperplasia, run by Diskapi Teaching 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: finished, as of the sponsor's last update on 18 Dec 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration of the spinal block (S1 regression of the block) (time frame: participanta will be followed on the operation day). 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 NCT01675895, which also lists 1 linked publication.
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 18 Dec 2012.