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Subsartorial Nerve Block and Femoral Nerve Block in Total Knee Arthroplasty

ConditionsJoint DiseasesJoint Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLuzerner Kantonsspital

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age > 18yrs

primary TKA

BMI 35kg/m2 or less

able to give informed consent as documented by signature

Disqualifiers

age < 18 years

revision-TKA

BMI >35kg/m2

absent contact information

Trial design

Design model

Parallel

Treatments tested in this trial

  • SSNB + IPACK

    Other intervention

    already included in arm/group description

  • FNB + IPACK

    Other intervention

    already included in arm/group description

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Intervention group: SSNB + IPACK (group 1)Active comparator 1 intervention
Group B: Control group: FNB + IPACK (group 2)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
preoperative, 6 weeks, 12 weeks, 1 year after surgery

Secondary outcomes

1

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)

Time frame
preoperative, 48 hours after surgery, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery
2

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)

Time frame
preoperative, 48 hours after surgery, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks1 year after surgery
3

Clinical results

redness, swelling, hyperthermia, wound/scar, range of motion, stability, adverse events

Time frame
preoperative, day of discharge (7+/- 2 days postoperative), 6, 12 weeks, 1 year after surgery
4

Radiological results

x-rays ap and lateral view(1), patella(2), whole leg axis(3)

Time frame
preoperative(1-3), day 1 after surgery(1), 6 weeks(1-2), 1 year after surgery(1-3)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Luzerner Kantonsspital

Lead sponsor

Source ClinicalTrials.gov
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