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Completed

NCT Number: NCT01356797

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital La Colina

Santa Cruz de Tenerife, Santa Cruz, 38007, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hypobaric levobupivacaine with fentanyl

Drug

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

Other names: Chirocane

hyperbaric bupivacaine 0,5%

Drug

SUSA with 4 mg hyperbaric bupivacaine 0.5%

Other names: Marchaine

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

USP Hospital La Colina

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 19, 2011
Registry last updated
Sep 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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