Total Knee Arthroplasty Analgesia: Single-shot Femoral Nerve Block or Epidural?
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|ClinicalTrials.gov Identifier: NCT02164825|
Recruitment Status : Completed
First Posted : June 17, 2014
Last Update Posted : February 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain Treatment for Total Knee Arthroplasty||Drug: Ropivacaine perineural injection Drug: morphine and ropivacaine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|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|
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.
- 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.
- 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.
- Rescue analgesic consumption. [ Time Frame: 48 hours ]Opioid rescue needs in the first 48 hours after surgery.
- Patients satisfaction. [ Time Frame: 48 hours ]Evaluation of patient´s satisfaction with pain control (asking the patient to classify the grade of satisfaction).
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
|Centro Hospitalar Tâmega e Sousa|
|Penafiel, Portugal, 4564-007|