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

NCT ID: NCT02071433

Last Updated: 2017-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Postoperative Analgesia for Anterior Cruciate Ligament Surgery of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Saphenous nerve blockade

Experimental treatment 15 mL of levobupivacaine 0.5%

Group Type EXPERIMENTAL

Saphenous nerve blockade

Intervention Type PROCEDURE

Femoral nerve blockade

Standard treatment 15 mL of levobupivacaine 0.5%

Group Type ACTIVE_COMPARATOR

Femoral nerve blockade

Intervention Type PROCEDURE

Interventions

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Saphenous nerve blockade

Intervention Type PROCEDURE

Femoral nerve blockade

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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W ten Hoope

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Academic Medical Centre Amsterdam

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Werner ten Hoope, MD

Role: CONTACT

0031-205663633

M.W. Hollmann, professor dr., MD

Role: CONTACT

0031-205663633

Facility Contacts

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M.W. Hollmanm

Role: primary

Other Identifiers

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ACLS

Identifier Type: -

Identifier Source: org_study_id

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