AnalgesiaPhase 3GENIFEMNCT05156476
GENIFEM Trial: Postoperative Pain After Total Knee Arthroplasty (TKA)
A Phase 3 study testing Genicular nerve block-iPACK group, Femoral triangle block-iPACK group and Local infiltration analgesia in people with Analgesia and Total Knee Arthroplasty, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Total Knee Arthroplasty
- What is being tested?
- Genicular nerve block-iPACK group, Femoral triangle block-iPACK group and Local infiltration analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Feb 2022to 25 May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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.
Read the 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.
- Conditions
- Analgesia, Total Knee Arthroplasty
- Being tested
- Genicular nerve block-iPACK group, Femoral triangle block-iPACK group, Local infiltration analgesia
- Keywords
- Genicular block, iPACK, Local Infiltration Analgesia (LIA), Femoral triangle nerve block, Postoperative analgesia, Total knee arthroplasty
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genicular nerve block-iPACK groupProcedure or surgery
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
Femoral triangle block-iPACK groupProcedure or surgery
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
Local infiltration analgesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Procedure: Local infiltration analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 to 6 hours after TKA
Secondary outcomes (19)
Pain assessed by NRS
NRS is determined at rest and movement at 24 hours, 48 hours, 72 hours and 1 month after TKA. 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.
Measured: 24 hours, 48 hours, 72 hours and 1 month
Post-operative morphine consumption and titration
The amount of morphine that the patient demanded and that was given will be determined at 4-6 hours, 24 hours, 48 hours and 72 hours after TKA
Measured: 4-6 hours, 24 hours, 48 hours and 72 hours after TKA
Quadriceps strength pre-and post operative
quadriceps strength measured in maximum voluntary isometric contraction (MVIC) at baseline (pre-operative), 4-6 hours, 24 hours, 48 hours after TKA
Measured: baseline, 4-6 hours, 24 hours, and 48 hours after TKA
6-minute walking test pre-and post operative
The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The 6 minute walking test will be performed at baseline (pre-operative), 24 hours, 48 hours and 72 hours after TKA
Measured: baseline, 24 hours, 48 hours and 72 hours after TKA
Timed up and go pre- and post operative
In the timed up and go test, subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. The results are expressed in minutes or seconds. The timed up and go test will be performed at baseline (pre-operative), 24 hours, 48 hours and 72 hours after TKA
Measured: baseline, 24 hours, 48 hours and 72 hours after TKA
Health status assessed by WOMAC: pre- and post-operative
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with osteoarthritis of the knee.
The test questions are scored on a scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. The questionnaire will be performed at baseline (pre-operative) and 1 month after TKA
Measured: baseline and 1 month after TKA
The change in health-related quality of life assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) questionnaire
The EQ-5D-5L is a patient-reported generic measure of HRQoL comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Responses to the 5 items (one for each dimension) result in a patient's health state that can be transformed into a utility score ranging between 0 (death) and 1 (full health), representing the quality of life of the health state.
Measured: baseline and 1 month after TKA
Assessment of anxiety and depression by the Hospital Anxiety and Depression Scale (HADS) questionnaire
HADS is developed to detect anxiety and depression in patients with physical health problems. The questionnaire consists of 14 items: 7 items to measure anxiety and 7 items to measure depression
Measured: baseline and 1 month after TKA
Measurement of patient satisfaction by the patient satisfaction scale
The patient satisfaction scale is measured in a 5-point Likert scale with response categories consisting of very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, and very dissatisfied
Measured: 72 hours and 1 month after TKA
Assessment of pain experience by the Pain Catastrophizing Scale (PCS)
The PCS is often used in clinical settings to measure catastrophic thinking related to pain. The 13 item questionnaire consists of 3 subscales (magnification, rumination and helplessness) and asks patients to reflect on past painful experiences and to indicate the degree on which they experiences each of 13 thoughts of feelings on a 5- point scale (0 not at all and 4 all the time).
Measured: baseline and 1 month after TKA
Nerve block time
(time from first needle insertion to final needle exit)
Measured: per-operative
Number and type of complications of TKA
Complications of TKA (e.g., transfusions, prevalence of venous thrombo-embolic event, infection…) will be assessed per - and post-operative
Measured: Through study completion, up to 1 month after randomisation and study intervention
Discharge readiness
The discharge readiness will be compared between the three groups.
Discharge readiness is assessed by means of the following:
- Pain is under control (<4) with oral painkillers
- Wound is dry (not purulent)
- Knee flexion is possible over 70 degrees
- Patients are self-sustainable with crutches
The discharge readiness is described as yes or no.
Measured: Through study completion, up to 1 month after randomisation
Length of stay
The length of stay will be compared between the three groups by counting the number of days in the hospital
Measured: Through study completion, up to 1 month after randomisation
Number of hospital readmissions (due to knee related problems at 1 month)
The readmission status of patients will be compared between groups after 1 month of TKA.
Measured: 1 month after TKA
Safety assessment by reporting adverse events
Throughout the study, adverse events related to the intervention will be collected.
Measured: Through study completion, up to 1 month after randomisation
Frequency of opioid related adverse event
The frequency of opioid related adverse event will be assessed from the start of surgery until 72 hours after TKA
Measured: 0 hours, 4-6 hours, 24 hours, 48 hours and 72 hours after TKA
Attributable mortality during the trial
Mortality which is attributable to study interventions, surgical procedure, underlying condition or other relevant reasons will be investigated during the trial (perioperative, until discharge)
Measured: during hospitalisation, an average of 3 days
Inpatient fall
The risk of inpatient fall will be assessed during hospital stay.
Measured: during hospitalisation, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start7 Feb 2022
- Primary completion25 May 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thibaut Vanneste, Ziekenhuis Oost-Limburg
- Investigators
- Thibaut Vanneste, MD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156476
- Sponsor's protocol ID
- Z-2021085
- Acronym
- GENIFEM
- Status last verified
- Jul 2023
- First submitted
- 20 Sep 2021
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40608549
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05156476
- Acronym / sponsor ID
- GENIFEM / Z-2021085
- Conditions
- Analgesia, Total Knee Arthroplasty
- Keywords
- Genicular block, iPACK, Local Infiltration Analgesia (LIA), Femoral triangle nerve block, Postoperative analgesia, Total knee arthroplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Genicular nerve block-iPACK group | Active comparator | Procedure: Genicular nerve block-iPACK groupGenicular 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. |
| Femoral triangle block-iPACK group | Active comparator | Procedure: Femoral triangle block-iPACK groupFemoral 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 |
| Local Infiltration Analgesia (LIA) | Active comparator | Procedure: Local infiltration analgesiaLIA (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genicular nerve block-iPACK groupGroup 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 | Procedure or surgery | Genicular nerve block-iPACK group |
| Femoral triangle block-iPACK groupGroup 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 | Procedure or surgery | Femoral triangle block-iPACK group |
| Local infiltration analgesiaGroup 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. | Procedure or surgery | Local Infiltration Analgesia (LIA) |
Primary outcome
Pain assessed by NRS at rest and movement: 4 -6 hours after TKA
Time frame: 4 to 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
19 secondary outcomes
Pain assessed by NRS
Time frame: 24 hours, 48 hours, 72 hours and 1 month
Post-operative morphine consumption and titration
Time frame: 4-6 hours, 24 hours, 48 hours and 72 hours after TKA
Quadriceps strength pre-and post operative
Time frame: baseline, 4-6 hours, 24 hours, and 48 hours after TKA
6-minute walking test pre-and post operative
Time frame: baseline, 24 hours, 48 hours and 72 hours after TKA
Timed up and go pre- and post operative
Time frame: baseline, 24 hours, 48 hours and 72 hours after TKA
Health status assessed by WOMAC: pre- and post-operative
Time frame: baseline and 1 month after TKA
The change in health-related quality of life assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) questionnaire
Time frame: baseline and 1 month after TKA
Assessment of anxiety and depression by the Hospital Anxiety and Depression Scale (HADS) questionnaire
Time frame: baseline and 1 month after TKA
Measurement of patient satisfaction by the patient satisfaction scale
Time frame: 72 hours and 1 month after TKA
Assessment of pain experience by the Pain Catastrophizing Scale (PCS)
Time frame: baseline and 1 month after TKA
Nerve block time
Time frame: per-operative
Number and type of complications of TKA
Time frame: Through study completion, up to 1 month after randomisation and study intervention
Discharge readiness
Time frame: Through study completion, up to 1 month after randomisation
Length of stay
Time frame: Through study completion, up to 1 month after randomisation
Number of hospital readmissions (due to knee related problems at 1 month)
Time frame: 1 month after TKA
Safety assessment by reporting adverse events
Time frame: Through study completion, up to 1 month after randomisation
Frequency of opioid related adverse event
Time frame: 0 hours, 4-6 hours, 24 hours, 48 hours and 72 hours after TKA
Attributable mortality during the trial
Time frame: during hospitalisation, an average of 3 days
Inpatient fall
Time frame: during hospitalisation, an average of 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Derived from this study: PubMed 40608549Belba 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.
Related trials for Analgesia
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruiting
Comparing Long-Acting Local Pain Relief Methods in PLIF Surgery
Posterior Lumbar Interbody Fusion (PLIF), Postoperative Analgesia After Disc Surgery
RecruitingPhase 1
Evaluation of the Safety and Effects of Psychoactive Substances in People With Past Opioid Use
Opioid Use, Substance Use Disorders
RecruitingObservational study
Effect of Ketamine on Optic Nerve Sheath Diameter During Procedural Analgesia
Procedural Pain, Procedural Sedation and Analgesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thibaut Vanneste, MD principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Genicular nerve block-iPACK group, Femoral triangle block-iPACK group and Local infiltration analgesia in people with Analgesia and Total Knee Arthroplasty, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessed by NRS at rest and movement: 4 -6 hours after TKA (time frame: 4 to 6 hours after TKA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05156476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.