Addition of Popliteal Plexus Block to Continuous Femoral Nerve Block for Total Knee Arthroplasty
Primary Purpose
Pain, Postoperative
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ropivacaine 0.5% Injectable Solution
Ropivacaine 0.5% Injectable Solution
Ropivacaine 0.5% Injectable Solution
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for total knee athroplasty under general anesthesia
- ASA 1-3
Exclusion Criteria:
- Kidney disease with GFR < 50 ml/mn
- Daily opioid consumption > 1 month
- Allergy to local anesthetics
- Neurological problems of the lower extremity
- other contraindications to peripheral nerve blocks
Sites / Locations
- Departement of Anesthesia, Hôpitaux Universitaires de GenèveRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Popliteal plexus block and continuous femoral nerve block
continuous femoral nerve block
Arm Description
Outcomes
Primary Outcome Measures
Total iv morphine consumption (mg)
Secondary Outcome Measures
Total iv morphine consumption (mg)
Average and maximum pain scores (Numeric rating scale 0-10)
Sciatic extension of popliteal plexus block
Presence of sensitive or/and motor sciatic extension of popliteal plexus block
Plantarflexion and dorsiflexion ankle strength (Newtons)
Knee pain localization (anterior, internal, posterior, lateral, medial)
Popliteal plexus block procedure time (minutes)
Onset of action = beginning of the disinfection; End of action = end of injection of 15 mls of Ropivacain 0.5%
Popliteal plexus block duration of action (hours)
Onset of action = Time from end of infection of 15 mls of Ropivacain 0.5%; End of action = onset of lateral and/or posterior knee pain (With Numeric rating scale ≥ 4)
Full Information
NCT ID
NCT04048889
First Posted
July 27, 2019
Last Updated
August 6, 2019
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT04048889
Brief Title
Addition of Popliteal Plexus Block to Continuous Femoral Nerve Block for Total Knee Arthroplasty
Official Title
Addition of Popliteal Plexus Block to Continuous Femoral Nerve Block for Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The popliteal plexus block has been described as an alternative analgesic postoperative pain treatment for total knee arthroplasty. It consists of injecting local anaeshetics inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor magnus muscle, in order to anesthetize the popliteal plexus. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore the objective of this study is to investigate the analgesic benefit of this block combined with a continuous femoral nerve block, on patients scheduled for total knee athroplasty.
Detailed Description
Patients scheduled to undergo total knee arthroplasty under general anesthesia will be randomly allocated to two groups: continuous femoral nerve block alone or continuous femoral nerve block with addition of a popliteal plexus block.
The continuous femoral nerve block will be performed by the anesthesiologist with 15 mLs of ropivacaine 0.5%, under ultrasound guidance before the beginning of the general anesthesia. The popliteal plexus block will be done by the anesthesiology, under ultrasound guidance, before the beginning of the surgery, under general anesthesia.
Postoperative analgesia will include acetaminophen (4 x 1000 mg), ibuprofen (3 x 400 mg) and a continuous infusion of Ropivacaine 0.2%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled triple-blinded trial
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Popliteal plexus block and continuous femoral nerve block
Arm Type
Experimental
Arm Title
continuous femoral nerve block
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5% Injectable Solution
Other Intervention Name(s)
Continous femoral nerve block
Intervention Description
Continuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5% Injectable Solution
Other Intervention Name(s)
Continous femoral nerve block
Intervention Description
Continuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5% Injectable Solution
Other Intervention Name(s)
Popliteal plexus block
Intervention Description
Popliteal plexus block with injection of 15 mls of Ropivacain 0.5% inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor Magnus muscle, done under general anesthesia.
Primary Outcome Measure Information:
Title
Total iv morphine consumption (mg)
Time Frame
12 postoperative hours
Secondary Outcome Measure Information:
Title
Total iv morphine consumption (mg)
Time Frame
24 and 48 postoperative hours
Title
Average and maximum pain scores (Numeric rating scale 0-10)
Time Frame
12, 24 and 48 postoperative hours
Title
Sciatic extension of popliteal plexus block
Description
Presence of sensitive or/and motor sciatic extension of popliteal plexus block
Time Frame
2 and 24 postoperative hours
Title
Plantarflexion and dorsiflexion ankle strength (Newtons)
Time Frame
2 and 24 postoperative hours
Title
Knee pain localization (anterior, internal, posterior, lateral, medial)
Time Frame
2, 12, 24 and 48 postoperative hours
Title
Popliteal plexus block procedure time (minutes)
Description
Onset of action = beginning of the disinfection; End of action = end of injection of 15 mls of Ropivacain 0.5%
Time Frame
When performing the popliteal plexus block
Title
Popliteal plexus block duration of action (hours)
Description
Onset of action = Time from end of infection of 15 mls of Ropivacain 0.5%; End of action = onset of lateral and/or posterior knee pain (With Numeric rating scale ≥ 4)
Time Frame
up to 48 postoperative hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for total knee athroplasty under general anesthesia
ASA 1-3
Exclusion Criteria:
Kidney disease with GFR < 50 ml/mn
Daily opioid consumption > 1 month
Allergy to local anesthetics
Neurological problems of the lower extremity
other contraindications to peripheral nerve blocks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Stebler, MD
Phone
0041795532149
Email
kevin.stebler@hcuge.ch
Facility Information:
Facility Name
Departement of Anesthesia, Hôpitaux Universitaires de Genève
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Stebler, MD
Phone
0041795532149
Email
kevin.stebler@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Roxane Fournier, PD
Phone
0041795532058
Email
roxabe.fournier@hcuge.ch
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Addition of Popliteal Plexus Block to Continuous Femoral Nerve Block for Total Knee Arthroplasty
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