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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01356797
First Posted: May 19, 2011
Last Update Posted: September 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jesus de Santiago Moragas, USP Hospital La Colina
  Purpose
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.

Condition Intervention Phase
Pain Drug: hypobaric levobupivacaine with fentanyl Drug: hyperbaric bupivacaine 0,5% Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Selective Unilateral Spinal Anesthesia Versus Selective Sensory Spinal Anesthesia for Knee Arthroscopy Surgery

Resource links provided by NLM:


Further study details as provided by Jesus de Santiago Moragas, USP Hospital La Colina:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Ambulation time after surgery [ Time Frame: every 30 minutes for an average of 3 hours ]
    In 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.


Enrollment: 54
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: hyperbaric bupivacaine Drug: hyperbaric bupivacaine 0,5%
SUSA with 4 mg hyperbaric bupivacaine 0.5%
Other Name: Marchaine
Experimental: hypobaric levobupivacaine with fentanyl Drug: hypobaric levobupivacaine with fentanyl
SSSA with 4 mg hypobaric levobupivacaine 0,13% with 10 mcg fentanyl
Other Name: Chirocane

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356797


Locations
Spain
Hospital La Colina
Santa Cruz de Tenerife, Santa Cruz, Spain, 38007
Sponsors and Collaborators
USP Hospital La Colina
Investigators
Principal Investigator: Jesus Santiago Moragas USP La Colina
Study Chair: Javier Santos-Yglesias Department of Anesthesiology, Hospital La colina
  More Information

Responsible Party: Jesus de Santiago Moragas, MD, USP Hospital La Colina
ClinicalTrials.gov Identifier: NCT01356797     History of Changes
Other Study ID Numbers: SUAK-1
First Submitted: May 10, 2011
First Posted: May 19, 2011
Last Update Posted: September 9, 2011
Last Verified: September 2011

Keywords provided by Jesus de Santiago Moragas, USP Hospital La Colina:
knee arthroscopy
hyperbaric bupivacaine
hypobaric levobupivacaine plus fentanyl

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Fentanyl
Levobupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General