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

Primary Purpose

Analgesia, Total Knee Arthroplasty

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Genicular nerve block-iPACK group
Femoral triangle block-iPACK group
Local infiltration analgesia
Sponsored by
Ziekenhuis Oost-Limburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring Genicular block, iPACK, Local Infiltration Analgesia (LIA), Femoral triangle nerve block, Postoperative analgesia, Total knee arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuis Oost-Limburg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Genicular nerve block-iPACK group

Femoral triangle block-iPACK group

Local Infiltration Analgesia (LIA)

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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
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
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
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
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.
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
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
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).
Nerve block time
(time from first needle insertion to final needle exit)
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
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.
Length of stay
The length of stay will be compared between the three groups by counting the number of days in the hospital
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.
Safety assessment by reporting adverse events
Throughout the study, adverse events related to the intervention will be collected.
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
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)
Inpatient fall
The risk of inpatient fall will be assessed during hospital stay.

Full Information

First Posted
September 20, 2021
Last Updated
July 20, 2023
Sponsor
Ziekenhuis Oost-Limburg
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1. Study Identification

Unique Protocol Identification Number
NCT05156476
Brief Title
GENIFEM Trial: Postoperative Pain After Total Knee Arthroplasty (TKA)
Acronym
GENIFEM
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
May 25, 2023 (Actual)
Study Completion Date
May 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziekenhuis Oost-Limburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Total Knee Arthroplasty
Keywords
Genicular block, iPACK, Local Infiltration Analgesia (LIA), Femoral triangle nerve block, Postoperative analgesia, Total knee arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Genicular nerve block-iPACK group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Femoral triangle block-iPACK group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Local Infiltration Analgesia (LIA)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Genicular nerve block-iPACK group
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Femoral triangle block-iPACK group
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Local infiltration analgesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain assessed by NRS at rest and movement: 4 -6 hours after TKA
Description
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
Time Frame
4 to 6 hours after TKA
Secondary Outcome Measure Information:
Title
Pain assessed by NRS
Description
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.
Time Frame
24 hours, 48 hours, 72 hours and 1 month
Title
Post-operative morphine consumption and titration
Description
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
Time Frame
4-6 hours, 24 hours, 48 hours and 72 hours after TKA
Title
Quadriceps strength pre-and post operative
Description
quadriceps strength measured in maximum voluntary isometric contraction (MVIC) at baseline (pre-operative), 4-6 hours, 24 hours, 48 hours after TKA
Time Frame
baseline, 4-6 hours, 24 hours, and 48 hours after TKA
Title
6-minute walking test pre-and post operative
Description
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
Time Frame
baseline, 24 hours, 48 hours and 72 hours after TKA
Title
Timed up and go pre- and post operative
Description
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
Time Frame
baseline, 24 hours, 48 hours and 72 hours after TKA
Title
Health status assessed by WOMAC: pre- and post-operative
Description
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
Time Frame
baseline and 1 month after TKA
Title
The change in health-related quality of life assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) questionnaire
Description
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.
Time Frame
baseline and 1 month after TKA
Title
Assessment of anxiety and depression by the Hospital Anxiety and Depression Scale (HADS) questionnaire
Description
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
Time Frame
baseline and 1 month after TKA
Title
Measurement of patient satisfaction by the patient satisfaction scale
Description
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
Time Frame
72 hours and 1 month after TKA
Title
Assessment of pain experience by the Pain Catastrophizing Scale (PCS)
Description
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).
Time Frame
baseline and 1 month after TKA
Title
Nerve block time
Description
(time from first needle insertion to final needle exit)
Time Frame
per-operative
Title
Number and type of complications of TKA
Description
Complications of TKA (e.g., transfusions, prevalence of venous thrombo-embolic event, infection…) will be assessed per - and post-operative
Time Frame
Through study completion, up to 1 month after randomisation and study intervention
Title
Discharge readiness
Description
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.
Time Frame
Through study completion, up to 1 month after randomisation
Title
Length of stay
Description
The length of stay will be compared between the three groups by counting the number of days in the hospital
Time Frame
Through study completion, up to 1 month after randomisation
Title
Number of hospital readmissions (due to knee related problems at 1 month)
Description
The readmission status of patients will be compared between groups after 1 month of TKA.
Time Frame
1 month after TKA
Title
Safety assessment by reporting adverse events
Description
Throughout the study, adverse events related to the intervention will be collected.
Time Frame
Through study completion, up to 1 month after randomisation
Title
Frequency of opioid related adverse event
Description
The frequency of opioid related adverse event will be assessed from the start of surgery until 72 hours after TKA
Time Frame
0 hours, 4-6 hours, 24 hours, 48 hours and 72 hours after TKA
Title
Attributable mortality during the trial
Description
Mortality which is attributable to study interventions, surgical procedure, underlying condition or other relevant reasons will be investigated during the trial (perioperative, until discharge)
Time Frame
during hospitalisation, an average of 3 days
Title
Inpatient fall
Description
The risk of inpatient fall will be assessed during hospital stay.
Time Frame
during hospitalisation, an average of 3 days
Other Pre-specified Outcome Measures:
Title
Success of blinding
Description
Patients will be asked to guess their treatment allocation at 72 hours after TKA
Time Frame
72 hours after TKA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thibaut Vanneste, MD
Organizational Affiliation
Ziekenhuis Oost-Limburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium

12. IPD Sharing Statement

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

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