GENIFEM Trial: Postoperative Pain After Total Knee Arthroplasty (TKA)

NCT05156476 | Completed Phase 3

• 1 other identifier: Z-2021085
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Total Knee Arthroplasty

Keywords

Genicular block; iPACK; Local Infiltration Analgesia (LIA); Femoral triangle nerve block; Postoperative analgesia; Total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Pain assessed by NRS at rest and movement: 4 -6 hours after TKA

  The main study outcome is the proportion of patients that have a numeral rating scale (NRS) \<4 during mobilization without morphine at 4-6 hours after TKA. Mobilisation will be defined as walking 10 meters with walking aids or an assistant. NRS is a unidimensional, subjective measurement of pain intensity, expressed by the patient as a number between 0 and 10. It is a 11 point scale in which 0 equals no pain and 10 maximal pain. NRS at rest will also be determined

  4 to 6 hours after TKA

Secondary Outcomes (19)

• Pain assessed by NRS

  24 hours, 48 hours, 72 hours and 1 month

• Post-operative morphine consumption and titration

  4-6 hours, 24 hours, 48 hours and 72 hours after TKA

• Quadriceps strength pre-and post operative

  baseline, 4-6 hours, 24 hours, and 48 hours after TKA

• 6-minute walking test pre-and post operative

  baseline, 24 hours, 48 hours and 72 hours after TKA

• Timed up and go pre- and post operative

  baseline, 24 hours, 48 hours and 72 hours after TKA

Other Outcomes (1)

• Success of blinding

  72 hours after TKA

Study Arms (3)

Genicular nerve block-iPACK group

ACTIVE COMPARATOR

Genicular nerve block-iPACK group (performed by anaesthesiologist) Method: Ultrasound and nerve stimulation guided injection Genicular nerve block will be performed on the the superomedial, the superolateral, the inferomedial and inferolateral genicular nerve. Drug: a total of 30 ml of ropivacaine 0.5% (150 mg) will be used for this treatment arm.

Procedure: Genicular nerve block-iPACK group

Femoral triangle block-iPACK group

ACTIVE COMPARATOR

Femoral triangle block-iPACK group (performed by anaesthesiologist) Method: Ultrasound and nerve stimulation guided injection Drug: a total of 30 ml of ropivacaine 0.5% (150 mg) will be used for this treatment arm

Procedure: Femoral triangle block-iPACK group

Local Infiltration Analgesia (LIA)

ACTIVE COMPARATOR

LIA (performed by surgeon) Method: Blind injection Drug: a total of 200 ml of 0.2% ropivacaine will be used (400 mg). Of this, 150 ml of ropivacaine 0.2% will be mixed with 1 mg of adrenaline.

Procedure: Local infiltration analgesia

Interventions

Genicular nerve block-iPACK group PROCEDURE

Group 1: Genicular nerve block-iPACK group (performed by anaesthesiologist) Method: Ultrasound and nerve stimulation guided injection Drug: a total of 30 ml of ropivacaine 0,5% (150 mg) will be used

Genicular nerve block-iPACK group

Femoral triangle block-iPACK group PROCEDURE

Group 2: Femoral triangle block-iPACK group (performed by anaesthesiologist) Method: Ultrasound and nerve stimulation guided injection Drug: a total of 30 ml of ropivacaine 0,5% (150 mg) will be used

Femoral triangle block-iPACK group

Local infiltration analgesia PROCEDURE

Group 3: LIA (performed by surgeon) Method: Blind injection Drug: a total of 200ml of 0.2% ropivacaine will be used (400mg). Of this, 150ml of ropivacaine 0.2% will be mixed with 1mg of adrenaline.

Local Infiltration Analgesia (LIA)

Eligibility Criteria

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

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3500, Belgium

Location

Related Publications (1)

• Belba A, Peene L, Mesotten D, Vanlommel L, Van Zundert J, Vanneste T; Collaborators. The GENIFEM Pilot Randomized Trial: Genicular Nerve Block vs Femoral Triangle Block vs Local Infiltration Analgesia for Total Knee Arthroplasty. Anesth Analg. 2026 Jan 1;142(1):186-189. doi: 10.1213/ANE.0000000000007622. Epub 2025 Jul 3. No abstract available.

  PMID: 40608549 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thibaut Vanneste, MD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: December 14, 2021
• Study Start: February 7, 2022
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

BE (1)