Subsartorial Nerve Block and Femoral Nerve Block in Total Knee Arthroplasty

Study Overview
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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?

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.

Official Title
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Subsartorial Saphenous Nerve Block (SSNB) Versus Femoral Nerve Block (FNB) in Primary Total Knee Arthroplasty (TKA) Combined With Infiltration Between Popliteal Artery and Capsule of the Knee (IPACK) - Where Are the Benefits?

Conditions
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Joint Diseases, Joint Pain

Intervention / Treatment
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* Other: SSNB + IPACK
* Other: FNB + IPACK


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group: SSNB + IPACK (group 1)<br>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 | Other: SSNB + IPACK<br>* already included in arm/group description<br>* Other names: Subsartorial Nerve Block;|
| Active Comparator: Control group: FNB + IPACK (group 2)<br>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 | Other: FNB + IPACK<br>* already included in arm/group description<br>* Other names: Femoral Nerve Block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional muscle power output of the leg | Cycle sprint test measuring maximum lower limb muscle power in Watts (W) from 3 times 10-second maximal efforts (higher values better) | preoperative, 6 weeks, 12 weeks, 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Manual muscle testing (MMT) as a standardized measuring tool to assess quadriceps muscle strength using a numeric score 0-5 (Daniels and Worthingham Scale): patient in sitting position in 20 degree knee flexion is asked to extend the knee actively against resistance proximal to the ankle (higher values better) | preoperative, 48 hours after surgery, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery | 
| Mobility | Timed up and go test (TUG): standardized measuring tool, the patient is timed while they rise from an arm chair (approximate seat height 46 cm), walk at a comfortable and safe pace to a line on the floor 3 metres away, turn and walk back to the chair and sit down again (in seconds) (lower values better) | preoperative, 48 hours after surgery, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks1 year after surgery | 
| Clinical results | redness, swelling, hyperthermia, wound/scar, range of motion, stability, adverse events | preoperative, day of discharge (7+/- 2 days postoperative), 6, 12 weeks, 1 year after surgery | 
| Radiological results | x-rays ap and lateral view(1), patella(2), whole leg axis(3) | preoperative(1-3), day 1 after surgery(1), 6 weeks(1-2), 1 year after surgery(1-3) | 
| Pain control | numeric rating scale 0-10 (lower values better) | before surgery, twice daily on the ward (except first 6 hours: hourly), day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery | 
| Opioid consumption | documentation of administered drugs including name of drug, dosage, frequency of use | before surgery, during hospital stay, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery | 
| Length of hospital stay | documentation of days in hospital | before surgery, during hospital stay, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery | 
| Patient satisfaction 1 | Questionnaire (Oxford Knee Score) 12-60 points (lower values better) | preoperative, 6 weeks, 12 weeks, 1 year after surgery | 
| Patient satisfaction 2 | Questionnaire (EQ-5D-5L) 5 questions with 5 answers each (lower values better) including EQ-VAS 0-100 (higher values better) | preoperative, 6 weeks, 12 weeks, 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subsartorial Saphenous Nerve Block (SSNB), Femoral Nerve Block (FNB), Total Knee Arthroplasty (TKA)