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

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ClinicalTrials.gov Identifier: NCT00927225
Recruitment Status : Completed
First Posted : June 24, 2009
Last Update Posted : June 24, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pain, Postoperative Drug: ropivacaine 0.2%, 50 mL Drug: normal saline Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Local Infiltration Analgesia in Bilateral Knee Arthroplasty - Efficacy of Subcutaneous Wound Infiltration With Local Anesthetic.
Study Start Date : September 2008
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 1-6 hours postoperative ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00927225


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

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
First Posted: June 24, 2009    Key Record Dates
Last Update Posted: June 24, 2009
Last Verified: June 2009

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