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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: hyperbaric bupivacaine 0,5%; Drug: hypobaric levobupivacaine with fentanyl

• Registration Number: NCT01356797
• Lead Sponsor: USP Hospital La Colina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-05-18
• Study First Posted: 2011-05-19
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2011-09-07
• Last Update Posted: 2011-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hyperbaric bupivacaine	hyperbaric bupivacaine 0,5%	-
hypobaric levobupivacaine with fentanyl	hypobaric levobupivacaine with fentanyl	-

Primary Outcome Measures

Name	Time	Method
time to discharge home	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

Name	Time	Method
Ambulation time after surgery	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.

Trial Locations

Locations (1)

Hospital La Colina; 🇪🇸 Santa Cruz de Tenerife, Santa Cruz, Spain