Analgesic Efficacy of Saphenous Nerve Blockade for Outpatient Knee Anterior Cruciate Ligament Surgery

Not Applicable

• Conditions: Postoperative Analgesia for Anterior Cruciate Ligament Surgery of the Knee
• Interventions: Procedure: Femoral nerve blockade; Procedure: Saphenous nerve blockade

• Registration Number: NCT02071433
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

The purpose of this study is to determine whether blockade of the saphenous nerve can provide the same degree of analgesia postoperatively for ACLS as a femoral nerve block without resulting motor blockade enhancing shortening of hospital stay en functional outcome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-25
• Study Start: 2014-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26
• Primary Completion: 2017-07
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• age 18-65 years
• ASA status I - III
• rupture of the anterior cruciate ligament.

Exclusion Criteria

• contraindication for regional anesthesia
• allergy against local anesthetics
• BMI > 35
• pre-existing diagnosed neuropathy of the operated leg
• ingestion of strong opioids
• pregnancy or breastfeeding status
• History of significant cardiovascular disease (MI, CVA, peripheral vascular disease)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral nerve blockade	Femoral nerve blockade	Standard treatment 15 mL of levobupivacaine 0.5%
Saphenous nerve blockade	Saphenous nerve blockade	Experimental treatment 15 mL of levobupivacaine 0.5%

Primary Outcome Measures

Name	Time	Method
Readiness to discharge from day-care center in hours according to Post-Anesthetic Discharge Scoring System (PADSS).[	1 day

Secondary Outcome Measures

Name	Time	Method
Sensory blockade extent	1 Day
Overall Benefit of Analgesia Score (OBAS)	6 weeks
SF-12 score	12 weeks
KOOS-score	12 weeks
IKDC-score	12 weeks
Motor block	2 days
Pain (VAS)	2 days
Time to rescue analgesic and post operative opioid consumption	1 Day

Trial Locations

Locations (1)

Academic Medical Centre Amsterdam; 🇳🇱 Amsterdam, Netherlands