Spinal Anesthesia Versus Combined Sciatic-femoral Nerve Block for Outpatient Knee Arthroscopy

Knee Arthritis Clinical Trial

Official title:

Spinale Unilaterale o Blocco Nervoso Periferico Per le Artroscopie di Ginocchio in Day Surgery. Confronto Prospettico Randomizzato

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384915
• Other study ID #: IOGPGC07
• Status: Completed
• Phase: Phase 4
• First received: February 20, 2015
• Last updated: May 7, 2015
• Start date: January 2015
• Est. completion date: May 2015

Study information

• Verified date: March 2015
• Source: ASST Gaetano Pini-CTO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare the time of home discharge in day-case patients receiving either a spinal anesthesia or a combined sciatic-femoral nerve block for knee arthroscopy

Description:

Two groups: the first receive a spinal anesthesia injecting 2% hyperbaric prilocaine 40 mg with the patients in lateral decubitus and the surgical limb declive, the second a combined ultrasound-guided sciatic-femoral nerve block injecting 25 ml of 2% mepivacaine solution.

Onset time, performance time, duration of the block, time of voiding, as well as the time of home discharge will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• outpatients knee arthroscopy

Exclusion Criteria:

• diabetes

• allergy to local anesthetic

• patient refusal

• chronic opiods assumption

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Arthritis

Intervention

Drug:
• prilocaine

• mepivacaine

Procedure:
• Sciatic-femoral Nerve Block
ultrasound-guided 25 ml 2% mepivacaine injection on both femoral and sciatic nerve
• Spinal anesthesia
intrathecal injection of 40 mg hyperbaric prilocaine

Device:
• Sonoplex, Pajunk

Locations

Country	Name	City	State
Italy	Istituto Ortopedico G. Pini	Milan	Milano

Sponsors (1)

Lead Sponsor	Collaborator
ASST Gaetano Pini-CTO

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to home discharge		12 hours	Yes