Subsartorial Nerve Block and Femoral Nerve Block in Total Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SSNB + IPACK, FNB + IPACK.
- Who it may be relevant to
- Registry conditions: Joint Diseases, Joint Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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?
Overview
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
- Other SSNB + IPACK
already included in arm/group description - Other FNB + IPACK
already included in arm/group description
Primary outcome measures
- Functional muscle power output of the leg [Time frame: preoperative, 6 weeks, 12 weeks, 1 year after surgery]
Secondary outcome measures (9)
- Muscle strength [Time frame: 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]
- Clinical results [Time frame: 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)]
- 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]
- Opioid consumption [Time frame: 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]
- Patient satisfaction 1 [Time frame: preoperative, 6 weeks, 12 weeks, 1 year after surgery]
- Patient satisfaction 2 [Time frame: preoperative, 6 weeks, 12 weeks, 1 year after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Luzerner Kantonsspital — Lucerne
Publications
- Declaration of Helsinki, Version October 2013
- International Conference on Harmonization (ICH) E6(R2) Guideline for Good Clinical Practice
- International Conference on Harmonization (ICH, 1997) E8 Guideline: General Considerations for Clinical Trials
- Implantatregister SIRIS Hüfte und Knie: Kurzfassung - SIRIS Report 2022
- Bundesamt für Statistik, Schweiz
- Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1744-58. doi: 10.1007/s00167-013-2750-2. Epub 2013 Nov 8. PMID 24201900
- Burket LW, Greenberg MS, Glick M. Burkett's Textbook of Oral Medicine. 10th ed. Philadelphia, PA: Lippincott
- Winnie AP, Ramamurthy S, Durrani Z. The inguinal paravascular technic of lumbar plexus anesthesia: the "3-in-1 block". Anesth Analg. 1973 Nov-Dec;52(6):989-96. No abstract available. PMID 4796576
Identifiers
NCT: NCT06074744 · SSNB2023