Selective Unilateral Spinal Anesthesia Versus Selective Sensory Spinal Anesthesia for Knee Arthroscopy Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- time to discharge home
Study Overview
Brief Summary
Background: Selective unilateral spinal anesthesia is the gold standard spinal anesthesia technique for knee arthroscopy. Selective sensory spinal anesthesia has recently been validated for this surgery. Both selective techniques are specially indicated for ambulatory surgery because of PACU fast track, low discharge home time and high patient satisfaction. This study compares both spinal techniques for knee arthroscopy surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adults scheduled to undergo knee arthroscopy
Exclusion Criteria
- •a previous history of neurological impairment
- •insulin-dependent diabetes mellitus
- •intolerance to the study drug or related compounds and additives
- •BMI > 38 kg/m2
- •height <155 cm or >180 cm
- •any existing contraindications for spinal anaesthesia
- •surgery in which a complete block of the lower limb
Arms & Interventions
hyperbaric bupivacaine
Intervention: hyperbaric bupivacaine 0,5% (Drug)
hypobaric levobupivacaine with fentanyl
Intervention: hypobaric levobupivacaine with fentanyl (Drug)
Outcomes
Primary Outcomes
time to discharge home
Time Frame: every 30 minutes for an average of 3 hours
In Day Surgery Unit, patients will be assessed for home discharge every 30 minutes and will be followed an expected average of three hours.
Secondary Outcomes
- Ambulation time after surgery(every 30 minutes for an average of 3 hours)
Investigators
Jesus de Santiago Moragas
MD
USP Hospital La Colina