Selective Unilateral Spinal Anesthesia Versus Selective Sensory Spinal Anesthesia for Knee Arthroscopy Surgery
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 pain
Started May 2011
Shorter than P25 for phase_4 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 10, 2011
CompletedFirst Posted
Study publicly available on registry
May 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedSeptember 9, 2011
September 1, 2011
4 months
May 10, 2011
September 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to discharge home
In Day Surgery Unit, patients will be assessed for home discharge every 30 minutes and will be followed an expected average of three hours.
every 30 minutes for an average of 3 hours
Secondary Outcomes (1)
Ambulation time after surgery
every 30 minutes for an average of 3 hours
Study Arms (2)
hyperbaric bupivacaine
ACTIVE COMPARATORhypobaric levobupivacaine with fentanyl
EXPERIMENTALInterventions
SSSA with 4 mg hypobaric levobupivacaine 0,13% with 10 mcg fentanyl
SUSA with 4 mg hyperbaric bupivacaine 0.5%
Eligibility Criteria
You may qualify if:
- adults scheduled to undergo knee arthroscopy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital La Colina
Santa Cruz de Tenerife, Santa Cruz, 38007, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesus Santiago Moragas
USP La Colina
- STUDY CHAIR
Javier Santos-Yglesias
Department of Anesthesiology, Hospital La colina
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 10, 2011
First Posted
May 19, 2011
Study Start
May 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
September 9, 2011
Record last verified: 2011-09