Subsartorial Nerve Block and Femoral Nerve Block in Total Knee Arthroplasty
NCT ID: NCT06074744
Last Updated: 2024-03-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
144 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-11-30
Study Completion Date
2026-12-31
Brief Summary
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The goal of this clinical trial is to compare two different types of nerve blocks in patients undergoing surgery for primary Total Knee Arthroplasty. The main question aim to answer is:
\- is there a benefit in functional muscle power output of the leg?
Participants will be randomized into either the intervention group or the control group and:
* receive Subsartorial Saphenous Nerve Block (SSNB) + IPACK in intervention group (group 1)
* receive Femoral Nerve Block (FNB) + IPACK in control group (group 2)
Researchers will compare the 2 groups to see if there are differences in :
* functional muscle power output of the leg?
* muscle function, mobility, clinical and radiological results, ROM, pain control (NRS), opioid consumption, length of hospital stay, patient satisfaction, mobility, reduction of costs?
\- is there a benefit in functional muscle power output of the leg?
Participants will be randomized into either the intervention group or the control group and:
* receive Subsartorial Saphenous Nerve Block (SSNB) + IPACK in intervention group (group 1)
* receive Femoral Nerve Block (FNB) + IPACK in control group (group 2)
Researchers will compare the 2 groups to see if there are differences in :
* functional muscle power output of the leg?
* muscle function, mobility, clinical and radiological results, ROM, pain control (NRS), opioid consumption, length of hospital stay, patient satisfaction, mobility, reduction of costs?
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Detailed Description
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Prospective, randomized, double-blinded, single-center, controlled clinical trial with intervention group (SSNB + IPACK, group 1) and control group (FNB + IPACK, group 2), randomization by sealed envelopes.
The number of participants will be 72 per group, calculated based on a sample size calculator program.
The 3 surgeons will be blinded as well as the patients regarding the nerve block they will receive.
We will explain to the patients how both the blocks will be carried out, that 1 block will be located "higher on the leg" and 1 "lower on the leg". The nerve blocks will be carried out by a well-trained anaesthesiologist following standard procedures preoperative.
The IPACK will be applied by the surgeons intraoperative, following a standard protocol. The used implant for all patients will be the cemented ATTUNE™ Primary Knee System® (DePuySynthes Johnson\&Johnson).
Every patient will wear a brace fixed in full extension after surgery for the first 24 hours. Postoperative all patients will receive a standard set of adequate analgesics.
The postoperative rehabilitation program will follow our well-established physiotherapy scheme.
Performed assessments:
* Range of motion (ROM)
* medical history
* physical examinations
* radiologic controls
* adverse events
* falls during hospital stay (standard protocol)
* pain assessment (numeric rating scale)
* Questionnaires (EQ-5D-5L und Oxford Knee Score) will be filled in by the patients
* Functional assessment: Cycle sprint test one a specially instrumented indoor bike (Verve Info Tec PTY LTD) fit with an instrumented crank (InfoCrank Power Meter, Verve Cycling, West Perth, Australia)
* Functional assessment: Manual muscle testing (MMT)
* Functional assessment: Timed up and go test (TUG)
Superiority analysis using a two sample t-test, significance level 0.05, power 80%.
Data will be stored electronically in the data base (RedCap). In case of missing data there will always be attempts to obtain these data afterwards (contacting the patients by phone). Further on statistical analysis is performed.
Dropouts, before the 6 weeks follow-up, will be replaced by recruitment of new subjects.
For quality assurance the sponsor, the Ethics Committee or an independent trial monitor may visit the research sites.
The number of participants will be 72 per group, calculated based on a sample size calculator program.
The 3 surgeons will be blinded as well as the patients regarding the nerve block they will receive.
We will explain to the patients how both the blocks will be carried out, that 1 block will be located "higher on the leg" and 1 "lower on the leg". The nerve blocks will be carried out by a well-trained anaesthesiologist following standard procedures preoperative.
The IPACK will be applied by the surgeons intraoperative, following a standard protocol. The used implant for all patients will be the cemented ATTUNE™ Primary Knee System® (DePuySynthes Johnson\&Johnson).
Every patient will wear a brace fixed in full extension after surgery for the first 24 hours. Postoperative all patients will receive a standard set of adequate analgesics.
The postoperative rehabilitation program will follow our well-established physiotherapy scheme.
Performed assessments:
* Range of motion (ROM)
* medical history
* physical examinations
* radiologic controls
* adverse events
* falls during hospital stay (standard protocol)
* pain assessment (numeric rating scale)
* Questionnaires (EQ-5D-5L und Oxford Knee Score) will be filled in by the patients
* Functional assessment: Cycle sprint test one a specially instrumented indoor bike (Verve Info Tec PTY LTD) fit with an instrumented crank (InfoCrank Power Meter, Verve Cycling, West Perth, Australia)
* Functional assessment: Manual muscle testing (MMT)
* Functional assessment: Timed up and go test (TUG)
Superiority analysis using a two sample t-test, significance level 0.05, power 80%.
Data will be stored electronically in the data base (RedCap). In case of missing data there will always be attempts to obtain these data afterwards (contacting the patients by phone). Further on statistical analysis is performed.
Dropouts, before the 6 weeks follow-up, will be replaced by recruitment of new subjects.
For quality assurance the sponsor, the Ethics Committee or an independent trial monitor may visit the research sites.
Conditions
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Joint Diseases
Joint Pain
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
randomization by sealed envelopes
Study Groups
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Intervention group: SSNB + IPACK (group 1)
Subsartorial Nerve Block:
* 15ml bupivacaine 0.5% + clonidine 1mcg/kg for prolongation of the block effect
* anatomic landmarks: proximal adductor channel, intersection of the medial borders of the sartorius muscle and the adductor longus, guided by ultrasound control
* no patch to puncture site to not jeopardise the surgeon's blinding
* IPACK: 15ml bupivacaine 0.5% after completion of the femoral preparation
Group Type
ACTIVE_COMPARATOR
SSNB + IPACK
Intervention Type
OTHER
already included in arm/group description
Control group: FNB + IPACK (group 2)
Femoral Nerve Block:
* 15ml bupivacaine 0.5% + clonidine 1mcg/kg for prolongation of the block effect
* anatomic landmarks: lateral to the femoral artery,level of the femoral crease (proximal to the vascular outlet of the deep artery of the thigh), femoral nerve lies on the surface of the iliopsoas muscle and is covered by the fascia iliaca, guided by ultrasound control
* no patch to puncture site to not jeopardise the surgeon's blinding
* IPACK: 15ml bupivacaine 0.5% after completion of the femoral preparation
Group Type
ACTIVE_COMPARATOR
FNB + IPACK
Intervention Type
OTHER
already included in arm/group description
Interventions
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SSNB + IPACK
already included in arm/group description
Intervention Type
OTHER
FNB + IPACK
already included in arm/group description
Intervention Type
OTHER
Other Intervention Names
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Subsartorial Nerve Block
Femoral Nerve Block
Eligibility Criteria
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Inclusion Criteria
* age \> 18yrs
* primary TKA
* BMI 35kg/m2 or less
* able to give informed consent as documented by signature
* clinical history without any contraindications for the planned intervention
* primary TKA
* BMI 35kg/m2 or less
* able to give informed consent as documented by signature
* clinical history without any contraindications for the planned intervention
Exclusion Criteria
* age \< 18 years
* revision-TKA
* BMI \>35kg/m2
* absent contact information
* inability or contraindications to undergo the investigated intervention (TKA, FNB, SSNB), - clinically significant concomitant diseases
* pregnancy
* inability to follow the procedures and follow-up procedures of the study (e.g. due to language problems, psychological disorders, dementia, living abroad, etc.
* withdrawal from the study
* revision-TKA
* BMI \>35kg/m2
* absent contact information
* inability or contraindications to undergo the investigated intervention (TKA, FNB, SSNB), - clinically significant concomitant diseases
* pregnancy
* inability to follow the procedures and follow-up procedures of the study (e.g. due to language problems, psychological disorders, dementia, living abroad, etc.
* withdrawal from the study
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Luzerner Kantonsspital
OTHER
Sponsor Role
lead
Responsible Party
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Judith Bering
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Judith Bering, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Luzerner Kantonsspital Luzern
Locations
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Luzerner Kantonsspital
Lucerne, , Switzerland
Site Status
RECRUITING
Countries
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Switzerland
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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SSNB2023
Identifier Type: -
Identifier Source: org_study_id
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