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Local Infiltration Analgesia in Bilateral Knee Arthroplasty - Efficacy of Subcutaneous Wound Infiltration With Local Anesthetic

This study has been completed.
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00927225
First received: June 23, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

Local infiltration analgesia is effective in total knee arthroplasty for postoperative pain management, but the efficacy of subcutaneous wound infiltration has not been evaluated. This study aims at evaluating the efficacy of subcutaneous wound infiltration in total knee arthroplasty in 16 patients undergoing bilateral knee arthroplasty.


Condition Intervention Phase
Pain, Postoperative
 Drug: ropivacaine 0.2%, 50 mL
Drug: normal saline
 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: Local Infiltration Analgesia in Bilateral Knee Arthroplasty - Efficacy of Subcutaneous Wound Infiltration With Local Anesthetic.

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: 1-6 hours postoperative ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: September 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: active
subcutaneous wound infiltration with 50 mL ropivacaine 0.2%
 Drug: ropivacaine 0.2%, 50 mL
Placebo Comparator: placebo
subcutaneous wound infiltration with 50 mL saline
 Drug: normal saline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • total bilateral knee arthroplasty

Exclusion Criteria:

  • immunological diseases
  • treatment with opioids or steroids
  • allergy to any drugs administered
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927225

Locations
Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Lundbeck Foundation
  More Information

No publications provided by Hvidovre University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lasse Andersen, Hvidovre Hospital
ClinicalTrials.gov Identifier: NCT00927225     History of Changes
Other Study ID Numbers: H-D-2008-104
Study First Received: June 23, 2009
Last Updated: June 23, 2009
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on May 19, 2013