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

January 25, 2017 updated by: W ten Hoope, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Recruiting
        • Academic Medical Centre Amsterdam
        • Contact:
        • Principal Investigator:
          • Werner ten Hoope, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Saphenous nerve blockade
Experimental treatment 15 mL of levobupivacaine 0.5%
Procedure: Saphenous nerve blockade
ACTIVE_COMPARATOR: Femoral nerve blockade
Standard treatment 15 mL of levobupivacaine 0.5%
Procedure: Femoral nerve blockade

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ANTICIPATED)

July 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

February 24, 2014

First Posted (ESTIMATE)

February 25, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACLS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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