Subsartorial Nerve Block and Femoral Nerve Block in Total Knee Arthroplasty

NCT06074744 | Recruiting

• 1 other identifier: SSNB2023
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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?

Conditions

Joint Diseases; Joint Pain

Keywords

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

Outcome Measures

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)

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

Secondary Outcomes (9)

• Muscle strength

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

• Mobility

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

• Clinical results

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

• Radiological results

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

• 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

Study Arms (2)

Intervention group: SSNB + IPACK (group 1)

ACTIVE COMPARATOR

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

Control group: FNB + IPACK (group 2)

ACTIVE COMPARATOR

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

Interventions

SSNB + IPACK OTHER

already included in arm/group description

Also known as: Subsartorial Nerve Block

Intervention group: SSNB + IPACK (group 1)

FNB + IPACK OTHER

already included in arm/group description

Also known as: Femoral Nerve Block

Control group: FNB + IPACK (group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

RECRUITING

Related Publications (44)

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MeSH Terms

Conditions

Joint Diseases; Arthralgia

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Judith Bering, Dr. med.

  Luzerner Kantonsspital Luzern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith Bering, Dr. med.

CONTACT

+41 41 205 18 91; judith.bering@luks.ch

Laura V Buchmann, Dr. med.

CONTACT

0041-41-2057855; laura.buchmann@luks.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: randomization by sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: October 10, 2023
• Study Start: November 30, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)