Meniscus LesionPhase 4NCT02322372
Femoral Blockade and Low-dose Spinal Anesthesia in Outpatient Knee Arthroscopy
A Phase 4 study testing Femoral blockade and Intrathecal anesthesia in people with Meniscus Lesion, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The investigators of the current study aimed to evaluate the effect of spinal anesthesia with low dose bupivacaine combined with femoral blockade on duration of anesthesia and time of first analgesic requirement during postoperative period Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Meniscus Lesion
- What is being tested?
- Femoral blockade and Intrathecal anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2014to Dec 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II patients aged between 25-65 undergoing arthroscopic meniscus repair
Who cannot join
- Contraindications to regional anesthesia (coagulopathy, severe aortic stenosis, sever mitral stenosis, increased intracranial pressure, severe hypovolemia, presence of infection on the site of injection)
- Presence of previous spinal surgery
- Presence of diabetes mellitus
- Presence of neurological disturbance
- Uncooperated patients, patients not accepting to participate the study
- Allergy to study drugs
- ASA II-IV patients, BMI >38, Height < 150 cm and >190 cm
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Medical School Anesthesiology and ICU Department
Ankara
About this study
Official title: Comparison of Conventional Dose Spinal Anesthesia With Low-dose Spinal Anesthesia and Femoral Blockade Combination in Outpatient Knee Arthroscopy
The investigators of the current study aimed to evaluate the effect of spinal anesthesia with low dose bupivacaine combined with femoral blockade on duration of anesthesia and time of first analgesic requirement during postoperative period
Read the detailed description
Fifty patients undergoing arthroscopic meniscus repair were included to the current study.
The patients were allocated to two groups as the spinal anesthesia with conventional dose of heavy bupivacaine or spinal anesthesia with low dose heavy bupivacaine combined with femoral blockade.
Blood pressures and heart rates were recorded at the beginning, at the 0th minute following femoral block, at the 0th minute and in two-minute intervals following spinal anesthesia for 20 minutes and in five-minute intervals till the end of surgery.
The sensorial block and motor block in both extremities were recorded in two-minute intervals following spinal anesthesia and in five-minute intervals till the end of surgery The time of sensorial blockade to reach T12, maximum level of sensorial blockade level and the time to reach maximum level of sensorial blockade and the time for regression of sensorial blockade to L2, the time for regression of motor blockade were recorded.
- Conditions
- Meniscus Lesion
- Being tested
- Femoral blockade, Intrathecal anesthesia
- Keywords
- femoral blockade, bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral blockadeDrug
Also called Marcaine
Spinal anesthesia with heavy bupivacaine combined with femoral blockade with bupivacaine
Intrathecal anesthesiaDrug
Also called Marcaine
Spinal anesthesia with heavy bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group F | Active comparator | Ultrasound-guided femoral blockade with 15 mL of bupivacaine 0.5% diluted in 15 mL saline was performed in supine position. Then the patient was turned to lateral decubitus position with the operated extremity on dependant position and intrathecal injection of heavy bupivacaine 1 mL (5 mg) was administered from L3-L4 intervertebral space at a rate of 1 mL/20 second.
. Receives: Drug: Femoral blockade |
| Group S | Active comparator | The patient was turned to lateral decubitus position with the operated extremity on dependant position and intrathecal injection of heavy bupivacaine 2 mL (10 mg) was administered from L3-L4 intervertebral space at a rate of 1 mL/20 second. Receives: Drug: Intrathecal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of sensorial block to regress L2
Measured: 24 hours
Secondary outcomes (1)
Time of first analgesic requirement
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 posted23 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
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 Meniscus LesionStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanem Cakar Turhan, Ankara University
- Investigators
- Ramazan Akmese, Specialist, Principal investigator, Ankara University Faculty of MedicineFatma Ozkan, Assistant, Principal investigator, Ankara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322372
- Sponsor's protocol ID
- 30/06/2014
- Status last verified
- Feb 2015
- First submitted
- 13 Dec 2014
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Turhan KS, Akmese R, Ozkan F, Okten FF. Comparison of low-dose spinal anesthesia and single-shot femoral block combination with conventional dose spinal anesthesia in outpatient arthroscopic meniscus repair. Eur Rev Med Pharmacol Sci. 2015 Apr;19(8):1489-97.
PubMed 25967725
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Dose Spinal Anesthesia With Low-dose Spinal Anesthesia and Femoral Blockade Combination in Outpatient Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT02322372
- Acronym / sponsor ID
- 30/06/2014
- Conditions
- Meniscus Lesion
- Keywords
- femoral blockade, bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Dec 2014 (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 investigators of the current study aimed to evaluate the effect of spinal anesthesia with low dose bupivacaine combined with femoral blockade on duration of anesthesia and time of first analgesic requirement during postoperative period
Detailed description
Fifty patients undergoing arthroscopic meniscus repair were included to the current study.
The patients were allocated to two groups as the spinal anesthesia with conventional dose of heavy bupivacaine or spinal anesthesia with low dose heavy bupivacaine combined with femoral blockade.
Blood pressures and heart rates were recorded at the beginning, at the 0th minute following femoral block, at the 0th minute and in two-minute intervals following spinal anesthesia for 20 minutes and in five-minute intervals till the end of surgery.
The sensorial block and motor block in both extremities were recorded in two-minute intervals following spinal anesthesia and in five-minute intervals till the end of surgery The time of sensorial blockade to reach T12, maximum level of sensorial blockade level and the time to reach maximum level of sensorial blockade and the time for regression of sensorial blockade to L2, the time for regression of motor blockade were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group F | Active comparator | Drug: Femoral blockadeUltrasound-guided femoral blockade with 15 mL of bupivacaine 0.5% diluted in 15 mL saline was performed in supine position. Then the patient was turned to lateral decubitus position with the operated extremity on dependant position and intrathecal injection of heavy bupivacaine 1 mL (5 mg) was administered from L3-L4 intervertebral space at a rate of 1 mL/20 second. . |
| Group S | Active comparator | Drug: Intrathecal anesthesiaThe patient was turned to lateral decubitus position with the operated extremity on dependant position and intrathecal injection of heavy bupivacaine 2 mL (10 mg) was administered from L3-L4 intervertebral space at a rate of 1 mL/20 second. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-II patients aged between 25-65 undergoing arthroscopic meniscus repair
Key exclusion criteria (7 listed)
- Contraindications to regional anesthesia (coagulopathy, severe aortic stenosis, sever mitral stenosis, increased intracranial pressure, severe hypovolemia, presence of infection on the site of injection)
- Presence of previous spinal surgery
- Presence of diabetes mellitus
- Presence of neurological disturbance
- Uncooperated patients, patients not accepting to participate 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 |
|---|---|---|
| Femoral blockadeAlso: MarcaineSpinal anesthesia with heavy bupivacaine combined with femoral blockade with bupivacaine | Drug | Group F |
| Intrathecal anesthesiaAlso: MarcaineSpinal anesthesia with heavy bupivacaine | Drug | Group S |
Primary outcome
Time of sensorial block to regress L2
Time frame: 24 hours
1 secondary outcome
Time of first analgesic requirement
Time frame: 24 hours
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 Feb 2015.
- Derived from this study: PubMed 25967725Turhan KS, Akmese R, Ozkan F, Okten FF. Comparison of low-dose spinal anesthesia and single-shot femoral block combination with conventional dose spinal anesthesia in outpatient arthroscopic meniscus repair. Eur Rev Med Pharmacol Sci. 2015 Apr;19(8):1489-97.
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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.
Ramazan Akmese, Specialist principal investigator
Ankara University Faculty of Medicine
Fatma Ozkan, Assistant principal investigator
Ankara University Faculty of Medicine
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 Femoral blockade and Intrathecal anesthesia in people with Meniscus Lesion, run by Ankara 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 1 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 18 Feb 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 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?
Time of sensorial block to regress L2 (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 NCT02322372, 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 Feb 2015.