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Selective Unilateral Spinal Anesthesia Versus Selective Sensory Spinal Anesthesia for Knee Arthroscopy Surgery

Selective Unilateral Spinal Anesthesia Versus Selective Sensory Spinal Anesthesia for Knee Arthroscopy Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01356797
Enrollment
54
Registered
2011-05-19
Start date
2011-05-31
Completion date
2011-09-30
Last updated
2011-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

knee arthroscopy, hyperbaric bupivacaine, hypobaric levobupivacaine plus fentanyl

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.

Interventions

DRUGhypobaric levobupivacaine with fentanyl

SSSA with 4 mg hypobaric levobupivacaine 0,13% with 10 mcg fentanyl

DRUGhyperbaric bupivacaine 0,5%

SUSA with 4 mg hyperbaric bupivacaine 0.5%

Sponsors

USP Hospital La Colina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
time to discharge homeevery 30 minutes for an average of 3 hoursIn Day Surgery Unit, patients will be assessed for home discharge every 30 minutes and will be followed an expected average of three hours.

Secondary

MeasureTime frameDescription
Ambulation time after surgeryevery 30 minutes for an average of 3 hoursIn PACU and in Day Surgery Unit, patients will be assessed for unassisted ambulation every 30 minutes and will be followed an expected average of three hours.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026