Local Anesthetic in Total Knee Arthroplasty (TKA): Volume Versus Concentration

This study has been completed.
Sponsor:
Information provided by:
Lundbeck Foundation
ClinicalTrials.gov Identifier:
NCT01012232
First received: November 10, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

In a randomized, double-blind, cross-over trial, 48 patients scheduled for total knee arthroplasty with placement of an intracapsular catheter will be randomized to receive bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL) or low volume/high concentration (10 mL, 10 mg/mL) 6 and 24 hours postoperatively, and pain will be assessed at rest and with mobilization for 2 hours after injections.


Condition Intervention Phase
Postoperative Pain
Analgesic Efficacy
Drug: 20 mL ropivacaine 5 mg/mL
Drug: 10 mL ropivacaine 10 mg/mL
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Volume-concentration Relationship of Analgesic Efficacy With Intra-capsular Local Anesthetic in Total Knee Arthroplasty: a Randomized, Double-blind, Cross-over Trial.

Resource links provided by NLM:


Further study details as provided by Lundbeck Foundation:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: 32 hours postoperative ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: June 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: low volume local anesthetic
bolus injection of local anesthetic in low volume/high concentration (10 mL, 10 mg/mL)
Drug: 10 mL ropivacaine 10 mg/mL
Experimental: high volume local anesthetic
bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL)
Drug: 20 mL ropivacaine 5 mg/mL

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for total knee arthroplasty
  • Able to give informed oral and written consent to participate

Exclusion Criteria:

  • Treatment with opioids or steroids, rheumatoid arthritis or other immunological diseases
  • History of stroke or any neurological or psychiatric disease potentially influencing pain perception (e.g. depression, diabetic neuropathy etc.)
  • Allergies to any of the drugs administered.
  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: NCT01012232

Locations
Denmark
Lundbeck Centre for fast-track hip and knee arthroplasty
Copenhagen, Denmark
Sponsors and Collaborators
Lundbeck Foundation
  More Information

No publications provided

Responsible Party: Lasse Andersen, The Lundbeck Centre for Fast-track Hip and Knee Arthroplasty
ClinicalTrials.gov Identifier: NCT01012232     History of Changes
Other Study ID Numbers: H-D-2009-016
Study First Received: November 10, 2009
Last Updated: November 10, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Lundbeck Foundation:
total knee arthroplasty
postoperative pain

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

ClinicalTrials.gov processed this record on September 16, 2014