Analgesic Efficacy of Saphenous Nerve Blockade for Outpat... | NCT02071433

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Jul 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Feb 24, 2014

First Submission Date that Met QC Criteria

Feb 24, 2014

First Posted Date

Feb 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2017

Last Update Posted Date

Jan 26, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

W ten Hoope, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Principal Investigator

Lead Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Saphenous nerve blockade	Experimental	Experimental treatment 15 mL of levobupivacaine 0.5%	Procedure: Saphenous nerve blockade
Femoral nerve blockade	Active Comparator	Standard treatment 15 mL of levobupivacaine 0.5%	Procedure: Femoral nerve blockade

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Saphenous nerve blockade	Procedure		Saphenous nerve blockade
Femoral nerve blockade

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Motor block		2 days
Pain (VAS)		2 days
Sensory blockade extent

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Werner ten Hoope, MD	Contact	0031-205663633		w.tenhoope@amc.uva.nl
M.W. Hollmann, professor dr., MD	Contact	0031-205663633		m.w.hollmann@amc.uva.nl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Academic Medical Centre Amsterdam	Recruiting	Amsterdam		1105 AZ	Netherlands

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms