This Study Was Focused on Selective Spinal Anesthesia for Lower Extremity Surgery in Order to Achieve Early Mobilization and to Shorten Hospital StayPhase 4NCT01938755
Hyperbaric Levobupivacaine for Spinal Anaesthesia
A Phase 4 study testing levobupivacaine in people with This Study Was Focused on Selective Spinal Anesthesia for Lower Extremity Surgery in Order to Achieve Early Mobilization and to Shorten Hospital Stay, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
Spinal anaesthesia also called spinal block or sub-arachnoid block (SAB), is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space, generally through a fine needle. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- This Study Was Focused on Selective Spinal Anesthesia for Lower Extremity Surgery in Order to Achieve Early Mobilization and to Shorten Hospital Stay
- What is being tested?
- levobupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2013to Jan 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Approval to participate in the study and spinal anesthesia
- American society of anesthesia (ASA) I,II physical status
- Scheduled for lower extremity surgery
Who cannot join
- Refuse to participate in the study
- American society of anesthesia (ASA)III, IV physical status
- Hypersensitivity to local anesthetics
- Emergency surgery
- Chronic pain treatment
- Peripheral neuropathy
- Severe systemic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Anestesia and Reanimation Dept.; Ordu University Education and Research Hospital
Ordu, Ordu, 52100
About this study
Spinal anaesthesia also called spinal block or sub-arachnoid block (SAB), is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space, generally through a fine needle.
There is no generic hyperbaric form of levobupivacaine currently available so we aimed in this study that to find the appropriate concentration of the levobupivacaine which achieves unilateral spinal anesthesia. The potential benefits of this type of anesthesia are less motor blockade and urinary retention, decrease in hospital stay. Therefore, it seems to be suitable for outpatient anesthesia.
- Being tested
- levobupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levobupivacaineDrug
levobupivacaine plus 60 mg dextrose
levobupivacaineDrug
levobupivacaine plus 80 mg dextrose
levobupivacaineDrug
levobupivacaine plus 100 mg dextrose
| Study group | Role | What they receive |
|---|---|---|
| levobupivacaine I | Experimental | group that was administered levobupivacaine plus 60mg dextrose Receives: Drug: levobupivacaine |
| levobupivacaine II | Experimental | group that was administered levobupivacaine plus 80 mg dextrose Receives: Drug: levobupivacaine |
| levobupivacaine III | Experimental | group that was administered levobupivacaine plus 100 mg dextrose Receives: Drug: levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of motor blockade
Measured: until dissolve of motor blockade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This Study Was Focused on Selective Spinal Anesthesia for Lower Extremity Surgery in Order to Achieve Early Mobilization and to Shorten Hospital StayStudies 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
- Crossover
- Masking
- Double blind
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, özgür yağan, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938755
- Sponsor's protocol ID
- odu52
- Status last verified
- Apr 2017
- First submitted
- 5 Sep 2013
- Last updated
- 5 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Levobupivacaine for Spinal Anaesthesia
- ClinicalTrials.gov ID
- NCT01938755
- Acronym / sponsor ID
- odu52
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 10 Sep 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 anaesthesia also called spinal block or sub-arachnoid block (SAB), is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space, generally through a fine needle.
There is no generic hyperbaric form of levobupivacaine currently available so we aimed in this study that to find the appropriate concentration of the levobupivacaine which achieves unilateral spinal anesthesia. The potential benefits of this type of anesthesia are less motor blockade and urinary retention, decrease in hospital stay. Therefore, it seems to be suitable for outpatient anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| levobupivacaine I | Experimental | Drug: levobupivacainegroup that was administered levobupivacaine plus 60mg dextrose |
| levobupivacaine II | Experimental | Drug: levobupivacainegroup that was administered levobupivacaine plus 80 mg dextrose |
| levobupivacaine III | Experimental | Drug: levobupivacainegroup that was administered levobupivacaine plus 100 mg dextrose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Approval to participate in the study and spinal anesthesia
- American society of anesthesia (ASA) I,II physical status
- Scheduled for lower extremity surgery
Key exclusion criteria (7 listed)
- Refuse to participate in the study
- American society of anesthesia (ASA)III, IV physical status
- Hypersensitivity to local anesthetics
- Emergency surgery
- Chronic pain treatment
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 |
|---|---|---|
| levobupivacainelevobupivacaine plus 60 mg dextrose | Drug | levobupivacaine I |
| levobupivacainelevobupivacaine plus 80 mg dextrose | Drug | levobupivacaine II |
| levobupivacainelevobupivacaine plus 100 mg dextrose | Drug | levobupivacaine III |
Primary outcome
degree of motor blockade
Time frame: until dissolve of motor blockade
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 5 Apr 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with This Study Was Focused on Selective Spinal Anesthesia for Lower Extremity Surgery in Order to Achieve Early Mobilization and to Shorten Hospital Stay, run by Ordu University 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 3 inclusion and 7 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 5 Apr 2017. 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?
degree of motor blockade (time frame: until dissolve of motor blockade). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2017.