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

NCT02322372 | Completed Phase 4

• 1 other identifier: 30/06/2014
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Meniscus Lesion

Keywords

femoral blockade; bupivacaine

Outcome Measures

Primary Outcomes (1)

• Time of sensorial block to regress L2

  24 hours

Secondary Outcomes (1)

• Time of first analgesic requirement

  24 hours

Study Arms (2)

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. .

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.

Drug: Intrathecal anesthesia

Interventions

Femoral blockade DRUG

Spinal anesthesia with heavy bupivacaine combined with femoral blockade with bupivacaine

Also known as: Marcaine

Group F

Intrathecal anesthesia DRUG

Spinal anesthesia with heavy bupivacaine

Also known as: Marcaine

Group S

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II patients aged between 25-65 undergoing arthroscopic meniscus repair

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Medical School Anesthesiology and ICU Department

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 25967725 DERIVED

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ramazan Akmese, Specialist

  Ankara University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Fatma Ozkan, Assistant

  Ankara University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: December 13, 2014
• First Posted: December 23, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 18, 2015

Record last verified: 2015-02

Locations

TU (1)