Clinical trial NCT02322372: Femoral Blockade and Low-dose Spinal Anesthesia in Outpatient Knee Arthroscopy
Official title: Comparison of Conventional Dose Spinal Anesthesia With Low-dose Spinal Anesthesia and Femoral Blockade Combination in Outpatient Knee Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meniscus Lesion
Keywords: femoral blockade
bupivacaine
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time of sensorial block to regress L2
timeFrame: 24 hours
Secondary outcomes:
measure: Time of first analgesic requirement
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Medical School Anesthesiology and ICU Department
Study officials:
affiliation: Ankara University Faculty of Medicine
name: Ramazan Akmese, Specialist
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University Faculty of Medicine
name: Fatma Ozkan, Assistant
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.