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Total Knee Arthroplasty Analgesia: Single-shot Femoral Nerve Block or Epidural?

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.
 
ClinicalTrials.gov Identifier: NCT02164825
Recruitment Status : Completed
First Posted : June 17, 2014
Last Update Posted : February 5, 2015
Sponsor:
Information provided by (Responsible Party):
Mariana Marques da Cunha, Centro Hospitalar do Tâmega e Sousa

Brief Summary:
Single-shot femoral nerve block is similar to continuous epidural technique for postoperative analgesia in total knee arthroplasty

Condition or disease Intervention/treatment Phase
Postoperative Pain Treatment for Total Knee Arthroplasty Drug: Ropivacaine perineural injection Drug: morphine and ropivacaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison Between Single-shot Femoral Nerve Block and Epidural Techniques for Total Knee Arthroplasty: a Randomized Controlled Trial
Study Start Date : January 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single-shot nerve block
Efficacy compared to epidural
Drug: Ropivacaine perineural injection
Ultrasound guided single-shot femoral nerve block

Active Comparator: Continuous epidural
Continuous epidural perfusion
Drug: morphine and ropivacaine
Continuous epidural analgesic perfusion Epidural perfusion with morphine and ropivacaine.




Primary Outcome Measures :
  1. Pain Score on the numeric pain score [ Time Frame: 48 hours ]
    Patients will be evaluated at 48 hours. At these time frame pain score at rest and during movement will be accessed.


Secondary Outcome Measures :
  1. Side effects as a measure of safety and tolerability [ Time Frame: 48 hours ]
    Side effects of both interventions. Number of patients with side effects like nausea, vomiting, hypotension and pruritus.

  2. Rescue analgesic consumption. [ Time Frame: 48 hours ]
    Opioid rescue needs in the first 48 hours after surgery.

  3. Patients satisfaction. [ Time Frame: 48 hours ]
    Evaluation of patient´s satisfaction with pain control (asking the patient to classify the grade of satisfaction).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective total knee arthroplasty

Exclusion Criteria:

  • Coagulopathy
  • Neuropathy
  • Morbid obesity
  • local anesthetics allergy

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): NCT02164825


Locations
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Portugal
Centro Hospitalar Tâmega e Sousa
Penafiel, Portugal, 4564-007
Sponsors and Collaborators
Centro Hospitalar do Tâmega e Sousa
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Responsible Party: Mariana Marques da Cunha, MD, Centro Hospitalar do Tâmega e Sousa
ClinicalTrials.gov Identifier: NCT02164825    
Other Study ID Numbers: CHTSA001
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: June 2014
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics