- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02322372
Femoral Blockade and Low-dose Spinal Anesthesia in Outpatient Knee Arthroscopy
Comparison of Conventional Dose Spinal Anesthesia With Low-dose Spinal Anesthesia and Femoral Blockade Combination in Outpatient Knee Arthroscopy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Ankara, Turkey
- Ankara University Medical School Anesthesiology and ICU Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA I-II patients aged between 25-65 undergoing arthroscopic meniscus repair
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Group F
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. . |
Spinal anesthesia with heavy bupivacaine combined with femoral blockade with bupivacaine
Other Names:
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ACTIVE_COMPARATOR: Group S
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.
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Spinal anesthesia with heavy bupivacaine
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time of sensorial block to regress L2
Time Frame: 24 hours
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24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time of first analgesic requirement
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ramazan Akmese, Specialist, Ankara University Faculty of Medicine
- Principal Investigator: Fatma Ozkan, Assistant, Ankara University Faculty of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30/06/2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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