Clinical trial NCT05156476: GENIFEM Trial: Postoperative Pain After Total Knee Arthroplasty (TKA)
Official title: Genicular Nerve Block Versus Femoral Triangle Nerve Block Versus LIA for Postoperative Analgesia After Total Knee Arthroplasty: A Pilot Randomized Controlled Superiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Analgesia
Total Knee Arthroplasty
Keywords: Genicular block
iPACK
Local Infiltration Analgesia (LIA)
Femoral triangle nerve block
Postoperative analgesia
Total knee arthroplasty
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Motor-sparing analgesic interventions for patients undergoing total knee arthroplasty (TKA) are a key component of fast-track surgery.

The investigators want to estimate treatments effects, inclusion rate, and feasibility of conducting a future randomized controlled superiority trial and to assess whether the short-term postoperative analgesic effect and ambulation after a Genicular - Infiltration Between Popliteal Artery and Capsule of Knee (iPACK) block in patients undergoing unilateral primary TKA is superior to Femoral triangle - iPACK block and Local Infiltration Analgesia (LIA).

The study is a prospective, double-blind, triple-arm superiority pilot randomised controlled trial with a randomization rate 1:1:1.Group I will receive a Genicular - iPACK block, group II a Femoral Triangle - iPACK block and group III LIA.

The primary study outcome is the proportion of patients that are able to mobilise (defined as walk 10 meters with assistance) with a numerical rating scale (NRS) of equal or less than 4 without the use of opioids at 4-6 hours after TKA. Secondary outcomes are efficacy (measured in NRS, total morphine consumption, total morphine titrations), functionality (quadriceps strength, timed-up-and-go, 6-minute walk test, inpatient falls), frequency of opioid related adverse events, discharge readiness, patient satisfaction, health-related quality of life, length of stay (LOS), complications after TKA and adverse events related to the study interventions.

Detailed description: Total knee arthroplasty (TKA) is one of the most frequently performed orthopedic surgical procedures for the treatment of osteoarthritis of the knee. Fast-tract recovery protocols emphasize the importance of early mobilization and physiotherapy to improve functional recovery, reduce postoperative complications, and decrease the economic burden of TKA. As the patients having TKA typically have severe pain postoperatively, multimodal analgesic regimen in many institutions includes interventional analgesia modality, such as nerve blocks, to facilitate early mobilization. At this time however, no universal recommendation exists on what constitutes the optimal nerve block technique that provides favorable balance between motor sparing for ambulation and analgesia.

Various motor-sparing nerve blocks (e.g., femoral triangle block, adductor canal block, obturator nerve blocks, Infiltration Between Popliteal Artery and Capsule of Knee (iPACK), genicular nerve block and Local Infiltration Analgesia (LIA)) are viable options for interventional analgesia in patients undergoing TKA. By this study in patients having TKA, the investigators aim to compare the analgesia and ambulation between the genicular nerve block iPACK versus Femoral triangle nerve block + iPACK versus LIA.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age at screening
* Scheduled to undergo elective primary unilateral TKA
* American Society of Anaesthesiologists (ASA) physical status 1, 2 or 3
* Mentally competent to provide informed consent, to report pain intensity and to use patient-controlled analgesia
* Physically able to perform independently the baseline functionality tests

Exclusion Criteria:

* Obesity (BMI\>40)
* Previous open knee surgery
* Revision TKA or bilateral TKA
* Contraindication to the following study medication: ropivacaine, morphine, midazolam, ketorolac, propofol, remifentanil, clonidine, dexamethasone, acetaminophen
* Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
* Chronic widespread pain
* Radicular pain in index legClinical Study Protocol Version 1.0
* Preoperative strong opioid use within 3 days before surgery (with the exception of weak opioids: tramadol and codeine)
* Any chronic neuromuscular deficit affecting the peripheral nerves or muscles of the surgical extremity
* Impaired kidney function (Chronic kidney disease (CKD) G4-G5 according to Kidney Disease: Improving Global Outcomes (KDIGO) classification)
* Alcohol or drug abuse
* Pregnant, nursing or planning to become pregnant before treatment. Women of reproductive age will be tested on pregnancy prior to start of the study. Participants who get pregnant after the treatment during the follow-up period will not be excluded

Primary outcomes:
measure: Pain assessed by NRS at rest and movement: 4 -6 hours after TKA
timeFrame: 4 to 6 hours after TKA
Secondary outcomes:
measure: Pain assessed by NRS
timeFrame: 24 hours, 48 hours, 72 hours and 1 month
measure: Post-operative morphine consumption and titration
timeFrame: 4-6 hours, 24 hours, 48 hours and 72 hours after TKA
measure: Quadriceps strength pre-and post operative
timeFrame: baseline, 4-6 hours, 24 hours, and 48 hours after TKA
measure: 6-minute walking test pre-and post operative
timeFrame: baseline, 24 hours, 48 hours and 72 hours after TKA
measure: Timed up and go pre- and post operative
timeFrame: baseline, 24 hours, 48 hours and 72 hours after TKA
measure: Health status assessed by WOMAC: pre- and post-operative
timeFrame: baseline and 1 month after TKA
measure: The change in health-related quality of life assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) questionnaire
timeFrame: baseline and 1 month after TKA
measure: Assessment of anxiety and depression by the Hospital Anxiety and Depression Scale (HADS) questionnaire
timeFrame: baseline and 1 month after TKA
measure: Measurement of patient satisfaction by the patient satisfaction scale
timeFrame: 72 hours and 1 month after TKA
measure: Assessment of pain experience by the Pain Catastrophizing Scale (PCS)
timeFrame: baseline and 1 month after TKA
measure: Nerve block time
timeFrame: per-operative
measure: Number and type of complications of TKA
timeFrame: Through study completion, up to 1 month after randomisation and study intervention
measure: Discharge readiness
timeFrame: Through study completion, up to 1 month after randomisation
measure: Length of stay
timeFrame: Through study completion, up to 1 month after randomisation
measure: Number of hospital readmissions (due to knee related problems at 1 month)
timeFrame: 1 month after TKA
measure: Safety assessment by reporting adverse events
timeFrame: Through study completion, up to 1 month after randomisation
measure: Frequency of opioid related adverse event
timeFrame: 0 hours, 4-6 hours, 24 hours, 48 hours and 72 hours after TKA
measure: Attributable mortality during the trial
timeFrame: during hospitalisation, an average of 3 days
measure: Inpatient fall
timeFrame: during hospitalisation, an average of 3 days
Other outcomes:
measure: Success of blinding
timeFrame: 72 hours after TKA
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Thibaut Vanneste, MD
role: PRINCIPAL_INVESTIGATOR
References: