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

Meniscus Lesion Clinical Trial

Official title:

Comparison of Conventional Dose Spinal Anesthesia With Low-dose Spinal Anesthesia and Femoral Blockade Combination in Outpatient Knee Arthroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02322372
• Other study ID #: 30/06/2014
• Status: Completed
• Phase: Phase 4
• First received: December 13, 2014
• Last updated: February 15, 2015
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meniscus Lesion

Intervention

Drug:
• Femoral blockade
Spinal anesthesia with heavy bupivacaine combined with femoral blockade with bupivacaine
• Intrathecal anesthesia
Spinal anesthesia with heavy bupivacaine

Locations

Country	Name	City	State
Turkey	Ankara University Medical School Anesthesiology and ICU Department	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of sensorial block to regress L2		24 hours	Yes
Secondary	Time of first analgesic requirement		24 hours	Yes