Subsartorial Nerve Block and Femoral Nerve Block in Total Knee Arthroplasty

March 7, 2024 updated by: Judith Bering, Luzerner Kantonsspital

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?

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Luzern, Switzerland, 6000
        • Recruiting
        • Luzerner Kantonsspital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Judith Bering, Dr. med.
        • Sub-Investigator:
          • Urs W Müller, Prof. PH
        • Sub-Investigator:
          • Flavio Cagienard, Dr. med.
        • Sub-Investigator:
          • Laura V Buchmann, Dr. med.
        • Sub-Investigator:
          • Tobias Ulmer, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group: SSNB + IPACK (group 1)

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
already included in arm/group description
Other Names:
  • Subsartorial Nerve Block
Active Comparator: Control group: FNB + IPACK (group 2)

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
already included in arm/group description
Other Names:
  • Femoral Nerve Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional muscle power output of the leg
Time Frame: 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)
preoperative, 6 weeks, 12 weeks, 1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: 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)
preoperative, 48 hours after surgery, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery
Mobility
Time Frame: 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)
preoperative, 48 hours after surgery, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks1 year after surgery
Clinical results
Time Frame: 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
preoperative, day of discharge (7+/- 2 days postoperative), 6, 12 weeks, 1 year after surgery
Radiological results
Time Frame: 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)
preoperative(1-3), day 1 after surgery(1), 6 weeks(1-2), 1 year after surgery(1-3)
Pain control
Time Frame: 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)
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
Opioid consumption
Time Frame: 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
before surgery, during hospital stay, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery
Length of hospital stay
Time Frame: 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
before surgery, during hospital stay, day of discharge (7+/- 2 days postoperative), 6 weeks, 12 weeks, 1 year after surgery
Patient satisfaction 1
Time Frame: preoperative, 6 weeks, 12 weeks, 1 year after surgery
Questionnaire (Oxford Knee Score) 12-60 points (lower values better)
preoperative, 6 weeks, 12 weeks, 1 year after surgery
Patient satisfaction 2
Time Frame: 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)
preoperative, 6 weeks, 12 weeks, 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luzerner Kantonsspital

Investigators

  • Principal Investigator: Judith Bering, Dr. med., Luzerner Kantonsspital Luzern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSNB2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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