Femoral Blockade and Low-dose Spinal Anesthesia in Outpatient Knee Arthroscopy

NCT ID: NCT02322372

Last Updated: 2015-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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

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Meniscus Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

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Group Type ACTIVE_COMPARATOR

Femoral blockade

Intervention Type DRUG

Spinal anesthesia with heavy bupivacaine combined with femoral blockade with bupivacaine

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.

Group Type ACTIVE_COMPARATOR

Intrathecal anesthesia

Intervention Type DRUG

Spinal anesthesia with heavy bupivacaine

Interventions

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Femoral blockade

Spinal anesthesia with heavy bupivacaine combined with femoral blockade with bupivacaine

Intervention Type DRUG

Intrathecal anesthesia

Spinal anesthesia with heavy bupivacaine

Intervention Type DRUG

Other Intervention Names

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Marcaine Marcaine

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Sanem Cakar Turhan

Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ramazan Akmese, Specialist

Role: PRINCIPAL_INVESTIGATOR

Ankara University Faculty of Medicine

Fatma Ozkan, Assistant

Role: PRINCIPAL_INVESTIGATOR

Ankara University Faculty of Medicine

Locations

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Ankara University Medical School Anesthesiology and ICU Department

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 25967725 (View on PubMed)

Other Identifiers

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30/06/2014

Identifier Type: -

Identifier Source: org_study_id

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