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

Postoperative Analgesia for Anterior Cruciate Ligament Surgery of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02071433
• Other study ID #: ACLS
• Status: Recruiting
• Phase: N/A
• First received: February 24, 2014
• Last updated: January 25, 2017
• Start date: March 2014
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Werner ten Hoope, MD
• Phone: 0031-205663633
• Email: w.tenhoope[@]amc.uva.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Postoperative Analgesia for Anterior Cruciate Ligament Surgery of the Knee

Intervention

Procedure:
• Saphenous nerve blockade

• Femoral nerve blockade

Locations

Country	Name	City	State
Netherlands	Academic Medical Centre Amsterdam	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readiness to discharge from day-care center in hours according to Post-Anesthetic Discharge Scoring System (PADSS).[		1 day
Secondary	Motor block		2 days
Secondary	Pain (VAS)		2 days
Secondary	Sensory blockade extent		1 Day
Secondary	Time to rescue analgesic and post operative opioid consumption		1 Day
Secondary	Overall Benefit of Analgesia Score (OBAS)		6 weeks
Secondary	SF-12 score		12 weeks
Secondary	KOOS-score		12 weeks
Secondary	IKDC-score		12 weeks