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

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ClinicalTrials.gov Identifier: NCT02071433
Recruitment Status : Recruiting
First Posted : February 25, 2014
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
W ten Hoope, 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.

Condition or disease Intervention/treatment Phase
Postoperative Analgesia for Anterior Cruciate Ligament Surgery of the Knee Procedure: Saphenous nerve blockade Procedure: Femoral nerve blockade Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of Saphenous Nerve Blockade for Outpatient Knee Anterior Cruciate Ligament Surgery
Study Start Date : March 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

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



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

Secondary Outcome Measures :
  1. Motor block [ Time Frame: 2 days ]
  2. Pain (VAS) [ Time Frame: 2 days ]
  3. Sensory blockade extent [ Time Frame: 1 Day ]
  4. Time to rescue analgesic and post operative opioid consumption [ Time Frame: 1 Day ]
  5. Overall Benefit of Analgesia Score (OBAS) [ Time Frame: 6 weeks ]
  6. SF-12 score [ Time Frame: 12 weeks ]
  7. KOOS-score [ Time Frame: 12 weeks ]
  8. IKDC-score [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071433


Contacts
Contact: Werner ten Hoope, MD 0031-205663633 w.tenhoope@amc.uva.nl
Contact: M.W. Hollmann, professor dr., MD 0031-205663633 m.w.hollmann@amc.uva.nl

Locations
Netherlands
Academic Medical Centre Amsterdam Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: M.W. Hollmanm       m.w.hollmann@amc.uva.nl   
Principal Investigator: Werner ten Hoope, MD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Responsible Party: W ten Hoope, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02071433     History of Changes
Other Study ID Numbers: ACLS
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017

Keywords provided by W ten Hoope, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Saphenous nerve block
Adductor canal block
Anterior cruciate ligament
Pain management
Day care

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs