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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356797
• Other study ID #: SUAK-1
• Status: Completed
• Phase: Phase 4
• First received: May 10, 2011
• Last updated: September 7, 2011
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: USP Hospital La Colina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• hypobaric levobupivacaine with fentanyl
SSSA with 4 mg hypobaric levobupivacaine 0,13% with 10 mcg fentanyl
• hyperbaric bupivacaine 0,5%
SUSA with 4 mg hyperbaric bupivacaine 0.5%

Locations

Country	Name	City	State
Spain	Hospital La Colina	Santa Cruz de Tenerife	Santa Cruz

Sponsors (1)

Lead Sponsor	Collaborator
USP Hospital La Colina

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	every 30 minutes for an average of 3 hours	No
Secondary	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.	every 30 minutes for an average of 3 hours	No