We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Continuous Saphenous Nerve Block for Total Knee Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01332045
First Posted: April 8, 2011
Last Update Posted: January 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Henning Lykke Andersen, Frederiksberg University Hospital
  Purpose

Our study will compare the use of continuous saphenous nerve block performed at the adductor canal in addition to Local Infiltration Analgesia (LIA) versus a Sham block in addition to LIA for total knee replacement. The investigators hypothesize that the saphenous nerve block performed at the level of the adductor canal in addition to LIA provides better pain relief than the LIA alone without significantly compromising muscle strength and physiotherapy, enabling patients to mobilize early with reduced opioid consumption and les side effects.

The investigators will enroll a total of 40 patients (20 patients will receive continuous saphenous nerve block in addition to LIA and 20 will receive the sham block and LIA). Until discharge, the investigators will record patients' pain scores, opioid consumption, side effects and physical therapy progress.

If our study proves that the continuous saphenous nerve block in addition to LIA can effectively reduce postoperative pain scores to an acceptable level with better physical therapy progress and less opioid consumption, it could be seen as a more attractive alternative to LIA alone or other traditionally used methods of postoperative pain control that compromises muscle strength and physiotherapy.


Condition Intervention
Pain, Postoperative Procedure: continuous saphenous nerve block Procedure: Saline boluses in nerve catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Saphenous Nerve Block (Adductor Channel) and Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Henning Lykke Andersen, Frederiksberg University Hospital:

Primary Outcome Measures:
  • Pain scores [ Time Frame: 3 days postoperative ]
    VAS pain scores


Secondary Outcome Measures:
  • Opioid consumption [ Time Frame: 3 days postoperative ]
  • physical therapy progress [ Time Frame: 3 days postoperative ]

Enrollment: 40
Study Start Date: April 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Saline boluses in nerve catheter
A nerve catheter will be placed in the adductor canal using saline instead of Ropivacaine for intermittent boluses.
Procedure: Saline boluses in nerve catheter
A nerve catheter will be placed in the adductor canal using saline instead of Ropivacaine for intermittent boluses.
Active Comparator: Continuous saphenous nerve block
Postoperative intermittent boluses of 15 Ml Ropivacaine 7,5 mg/Ml every 12 hours for three days
Procedure: continuous saphenous nerve block
Postoperative intermittent boluses of 15 Ml Ropivacaine 7,5 mg/Ml every 12 hours for three days

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-III
  • Age: 40-75
  • Unilateral TKA
  • Use of Spinal anesthesia

Exclusion Criteria:

  • Allergy to any of the study medications
  • Intolerance to morphine
  • Contraindication to a spinal anesthetic
  • Intraoperative use of any volatile anesthetic
  • Chronic opioid use
  • ASA Class 4-5
  • Rheumatoid arthritis or Diabetes mellitus with neuropathy
  • Liver or kidney failure
  • BMI above 40
  • Severe COPD
  Contacts and Locations
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): NCT01332045


Locations
Denmark
Anaestesiafdelingen, Frederiksberg Hospital
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Henning Lykke Andersen
Investigators
Principal Investigator: Henning L. Andersen, M.D. Frederiksberg Hospital
Study Director: Dusanka Zaric, M.D., Ph.d. Frederiksberg Hospital.
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Henning Lykke Andersen, Consultant, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT01332045     History of Changes
Other Study ID Numbers: H-3-2010-124
First Submitted: April 7, 2011
First Posted: April 8, 2011
Last Update Posted: January 19, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents