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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jesus de Santiago Moragas, USP Hospital La Colina
ClinicalTrials.gov Identifier:
NCT01356797
First received: May 10, 2011
Last updated: September 7, 2011
Last verified: September 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by USP Hospital La Colina:

Primary Outcome Measures:
  • time to discharge home [ Time Frame: every 30 minutes for an average of 3 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jesus de Santiago Moragas, MD, USP Hospital La Colina
ClinicalTrials.gov Identifier: NCT01356797     History of Changes
Other Study ID Numbers: SUAK-1
Study First Received: May 10, 2011
Last Updated: September 7, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by 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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Narcotics
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 19, 2013