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Subsartorial Nerve Block and Femoral Nerve Block in Total Knee Arthroplasty

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?

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06074744
Enrollment
144
Registered
2023-10-10
Start date
2023-11-30
Completion date
2026-12-31
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Joint Diseases, Joint Pain

Keywords

Subsartorial Saphenous Nerve Block (SSNB), Femoral Nerve Block (FNB), Total Knee Arthroplasty (TKA)

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.

Interventions

OTHERSSNB + IPACK

already included in arm/group description

OTHERFNB + IPACK

already included in arm/group description

Sponsors

Luzerner Kantonsspital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

randomization by sealed envelopes

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functional muscle power output of the legpreoperative, 6 weeks, 12 weeks, 1 year after surgeryCycle sprint test measuring maximum lower limb muscle power in Watts (W) from 3 times 10-second maximal efforts (higher values better)

Secondary

MeasureTime frameDescription
Mobilitypreoperative, 48 hours after surgery, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks1 year after surgeryTimed 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)
Clinical resultspreoperative, day of discharge (7+/- 2 days postoperative), 6, 12 weeks, 1 year after surgeryredness, swelling, hyperthermia, wound/scar, range of motion, stability, adverse events
Radiological resultspreoperative(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)
Pain controlbefore 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 surgerynumeric rating scale 0-10 (lower values better)
Muscle strengthpreoperative, 48 hours after surgery, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgeryManual 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)
Length of hospital staybefore surgery, during hospital stay, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgerydocumentation of days in hospital
Patient satisfaction 1preoperative, 6 weeks, 12 weeks, 1 year after surgeryQuestionnaire (Oxford Knee Score) 12-60 points (lower values better)
Patient satisfaction 2preoperative, 6 weeks, 12 weeks, 1 year after surgeryQuestionnaire (EQ-5D-5L) 5 questions with 5 answers each (lower values better) including EQ-VAS 0-100 (higher values better)
Opioid consumptionbefore surgery, during hospital stay, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgerydocumentation of administered drugs including name of drug, dosage, frequency of use

Countries

Switzerland

Contacts

Primary ContactJudith Bering, Dr. med.
judith.bering@luks.ch+41 41 205 18 91
Backup ContactLaura V Buchmann, Dr. med.
laura.buchmann@luks.ch0041-41-2057855

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026