Continuous Saphenous Nerve Block for Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Henning Lykke Andersen, Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT01332045
First received: April 7, 2011
Last updated: January 18, 2012
Last verified: January 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Frederiksberg University Hospital:

Primary Outcome Measures:
  • Pain scores [ Time Frame: 3 days postoperative ] [ Designated as safety issue: No ]
    VAS pain scores


Secondary Outcome Measures:
  • Opioid consumption [ Time Frame: 3 days postoperative ] [ Designated as safety issue: No ]
  • physical therapy progress [ Time Frame: 3 days postoperative ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
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: 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:
No publications provided by Frederiksberg University Hospital

Additional 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
Study First Received: April 7, 2011
Last Updated: January 18, 2012
Health Authority: Denmark: National Board of Health

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

ClinicalTrials.gov processed this record on October 23, 2014