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CompletedNCT01356797Updated Sep 9, 2011

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

A Phase 4 interventional study of hypobaric levobupivacaine with fentanyl and hyperbaric bupivacaine 0,5% in Pain, sponsored by USP Hospital La Colina. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-09.

Sponsored by USP Hospital La Colina · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pain

Keywords

  • knee arthroscopy
  • hyperbaric bupivacaine
  • hypobaric levobupivacaine plus fentanyl
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In context

Lead sponsor

This is the only study on the registry with USP Hospital La Colina as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • adults scheduled to undergo knee arthroscopy

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    hyperbaric bupivacaine

    Drug: hyperbaric bupivacaine 0,5%

  • Experimental
    hypobaric levobupivacaine with fentanyl

    Drug: hypobaric levobupivacaine with fentanyl

Interventions

  • Drughypobaric levobupivacaine with fentanyl

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

    Also known as: Chirocane

  • Drughyperbaric bupivacaine 0,5%

    SUSA with 4 mg hyperbaric bupivacaine 0.5%

    Also known as: Marchaine

06

What researchers measure

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.

    Time frame: every 30 minutes for an average of 3 hours

Secondary outcomes

  1. Ambulation time after surgery

    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.

    Time frame: every 30 minutes for an average of 3 hours

07

Study locations

1 site
  • Hospital La Colina
    Santa Cruz de Tenerife, Santa Cruz 38007, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01356797
Lead sponsor
USP Hospital La Colina
Responsible party
Jesus de Santiago Moragas (MD, USP Hospital La Colina) — Principal investigator
First posted
May 19, 2011
Start date
May 2011
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Sep 9, 2011

Study contacts

Jesus Santiago Moragas
principal investigator · USP La Colina
Javier Santos-Yglesias
study chair · Department of Anesthesiology, Hospital La colina

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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