Subsartorial Nerve Block and Femoral Nerve Block in Total Knee Arthroplasty
- Conditions
- Joint DiseasesJoint Pain
- Interventions
- Other: SSNB + IPACKOther: FNB + IPACK
- Registration Number
- NCT06074744
- Lead Sponsor
- Luzerner Kantonsspital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 144
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group: SSNB + IPACK (group 1) SSNB + IPACK 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 Control group: FNB + IPACK (group 2) FNB + IPACK 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
- Primary Outcome Measures
Name Time Method Functional muscle power output of the leg preoperative, 6 weeks, 12 weeks, 1 year after surgery Cycle sprint test measuring maximum lower limb muscle power in Watts (W) from 3 times 10-second maximal efforts (higher values better)
- Secondary Outcome Measures
Name Time Method Opioid consumption before surgery, during hospital stay, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery documentation of administered drugs including name of drug, dosage, frequency of use
Length of hospital stay before surgery, during hospital stay, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery documentation of days in hospital
Muscle strength preoperative, 48 hours after surgery, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery 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)
Radiological results preoperative(1-3), day 1 after surgery(1), 6 weeks(1-2), 1 year after surgery(1-3) x-rays ap and lateral view(1), patella(2), whole leg axis(3)
Clinical results preoperative, day of discharge (7+/- 2 days postoperative), 6, 12 weeks, 1 year after surgery redness, swelling, hyperthermia, wound/scar, range of motion, stability, adverse events
Pain control 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 numeric rating scale 0-10 (lower values better)
Mobility preoperative, 48 hours after surgery, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks1 year after surgery 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)
Patient satisfaction 1 preoperative, 6 weeks, 12 weeks, 1 year after surgery Questionnaire (Oxford Knee Score) 12-60 points (lower values better)
Patient satisfaction 2 preoperative, 6 weeks, 12 weeks, 1 year after surgery Questionnaire (EQ-5D-5L) 5 questions with 5 answers each (lower values better) including EQ-VAS 0-100 (higher values better)
Trial Locations
- Locations (1)
Luzerner Kantonsspital
🇨🇭Luzern, Switzerland