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

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

Study Overview

• Status: Completed
• Conditions: Meniscus Lesion
• Intervention / Treatment: Drug: Femoral blockade; Drug: Intrathecal anesthesia

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: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara University Medical School Anesthesiology and ICU Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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. .	Drug: Femoral blockade; Spinal anesthesia with heavy bupivacaine combined with femoral blockade with bupivacaine; Other Names: Marcaine
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.	Drug: Intrathecal anesthesia; Spinal anesthesia with heavy bupivacaine; Other Names: Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time of sensorial block to regress L2	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Time of first analgesic requirement	24 hours

Collaborators and Investigators

• Sponsor: Ankara University
• 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

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: December 13, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (ESTIMATE): December 23, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 15, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: bupivacaine; femoral blockade
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 30/06/2014