Subsartorial Nerve Block and Femoral Nerve Block in Total Knee Arthroplasty

Joint Diseases Clinical Trial

Official title:

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074744
• Other study ID #: SSNB2023
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Luzerner Kantonsspital
• Contact: Judith Bering, Dr. med.
• Phone: +41 41 205 18 91
• Email: judith.bering[@]luks.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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 information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Joint Diseases
• Joint Pain

Intervention

Other:
• SSNB + IPACK
already included in arm/group description
• FNB + IPACK
already included in arm/group description

Locations

Country	Name	City	State
Switzerland	Luzerner Kantonsspital	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

References & Publications (44)

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient satisfaction 1	Questionnaire (Oxford Knee Score) 12-60 points (lower values better)	preoperative, 6 weeks, 12 weeks, 1 year after surgery
Secondary	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