Back to resultsTotal Knee Arthroplasty Analgesia: Single-shot Femoral Nerve Block or Epidural?
Primary Purpose
Postoperative Pain Treatment for Total Knee Arthroplasty
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Ropivacaine perineural injection
morphine and ropivacaine
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain Treatment for Total Knee Arthroplasty
Eligibility Criteria
Inclusion Criteria:
- Elective total knee arthroplasty
Exclusion Criteria:
- Coagulopathy
- Neuropathy
- Morbid obesity
- local anesthetics allergy
Sites / Locations
- Centro Hospitalar Tâmega e Sousa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Single-shot nerve block
Continuous epidural
Arm Description
Efficacy compared to epidural
Continuous epidural perfusion
Outcomes
Primary Outcome Measures
Pain Score on the numeric pain score
Patients will be evaluated at 48 hours. At these time frame pain score at rest and during movement will be accessed.
Secondary Outcome Measures
Side effects as a measure of safety and tolerability
Side effects of both interventions. Number of patients with side effects like nausea, vomiting, hypotension and pruritus.
Rescue analgesic consumption.
Opioid rescue needs in the first 48 hours after surgery.
Patients satisfaction.
Evaluation of patient´s satisfaction with pain control (asking the patient to classify the grade of satisfaction).
Full Information
NCT ID
NCT02164825
First Posted
June 5, 2014
Last Updated
February 4, 2015
Sponsor
Centro Hospitalar do Tâmega e Sousa
1. Study Identification
Unique Protocol Identification Number
NCT02164825
Brief Title
Total Knee Arthroplasty Analgesia: Single-shot Femoral Nerve Block or Epidural?
Official Title
Comparison Between Single-shot Femoral Nerve Block and Epidural Techniques for Total Knee Arthroplasty: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Hospitalar do Tâmega e Sousa
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Single-shot femoral nerve block is similar to continuous epidural technique for postoperative analgesia in total knee arthroplasty
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Treatment for Total Knee Arthroplasty
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-shot nerve block
Arm Type
Experimental
Arm Description
Efficacy compared to epidural
Arm Title
Continuous epidural
Arm Type
Active Comparator
Arm Description
Continuous epidural perfusion
Intervention Type
Drug
Intervention Name(s)
Ropivacaine perineural injection
Intervention Description
Ultrasound guided single-shot femoral nerve block
Intervention Type
Drug
Intervention Name(s)
morphine and ropivacaine
Intervention Description
Continuous epidural analgesic perfusion Epidural perfusion with morphine and ropivacaine.
Primary Outcome Measure Information:
Title
Pain Score on the numeric pain score
Description
Patients will be evaluated at 48 hours. At these time frame pain score at rest and during movement will be accessed.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Side effects as a measure of safety and tolerability
Description
Side effects of both interventions. Number of patients with side effects like nausea, vomiting, hypotension and pruritus.
Time Frame
48 hours
Title
Rescue analgesic consumption.
Description
Opioid rescue needs in the first 48 hours after surgery.
Time Frame
48 hours
Title
Patients satisfaction.
Description
Evaluation of patient´s satisfaction with pain control (asking the patient to classify the grade of satisfaction).
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective total knee arthroplasty
Exclusion Criteria:
Coagulopathy
Neuropathy
Morbid obesity
local anesthetics allergy
Facility Information:
Facility Name
Centro Hospitalar Tâmega e Sousa
City
Penafiel
ZIP/Postal Code
4564-007
Country
Portugal
12. IPD Sharing Statement
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Total Knee Arthroplasty Analgesia: Single-shot Femoral Nerve Block or Epidural?
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