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

September 7, 2011 updated by: Jesus de Santiago Moragas, USP Hospital La Colina
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Santa Cruz
      • Santa Cruz de Tenerife, Santa Cruz, Spain, 38007
        • Hospital La Colina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: hyperbaric bupivacaine
Drug: hyperbaric bupivacaine 0,5%
SUSA with 4 mg hyperbaric bupivacaine 0.5%
Other Names:
  • Marchaine
Experimental: hypobaric levobupivacaine with fentanyl
Drug: hypobaric levobupivacaine with fentanyl
SSSA with 4 mg hypobaric levobupivacaine 0,13% with 10 mcg fentanyl
Other Names:
  • Chirocane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every 30 minutes for an average of 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every 30 minutes for an average of 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USP Hospital La Colina

Investigators

  • Principal Investigator: Jesus Santiago Moragas, USP La Colina
  • Study Chair: Javier Santos-Yglesias, Department of Anesthesiology, Hospital La colina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

May 18, 2011

First Posted (Estimate)

May 19, 2011

Study Record Updates

Last Update Posted (Estimate)

September 9, 2011

Last Update Submitted That Met QC Criteria

September 7, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUAK-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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