Trial record 8 of 56 for:    Open Studies | "Anterior Cruciate Ligament"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Information provided by (Responsible Party):
W ten Hoope, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT02071433
First received: February 24, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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 Intervention
Postoperative Analgesia for Anterior Cruciate Ligament Surgery of the Knee
Procedure: Saphenous nerve blockade
Procedure: Femoral nerve blockade

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of Saphenous Nerve Blockade for Outpatient Knee Anterior Cruciate Ligament Surgery

Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Readiness to discharge from day-care center in hours according to Post-Anesthetic Discharge Scoring System (PADSS).[ [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Motor block [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Pain (VAS) [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Sensory blockade extent [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Time to rescue analgesic and post operative opioid consumption [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Overall Benefit of Analgesia Score (OBAS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • SF-12 score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • KOOS-score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • IKDC-score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 58
Study Start Date: March 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

No publications provided

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
Study First Received: February 24, 2014
Last Updated: February 24, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Ministry of Health, Welfare and Sport
Netherlands: Dutch Health Care Inspectorate

Keywords provided by 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
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014