Post-operative PainNCT06038851
Evaluation of the Analgesic Benefit of Adding the Blocks of the Intermediate and Medial Femoral Cutaneous Nerves in Addition to the Femoral Triangle Block for Postoperative Analgesia After a Knee Replacement Surgery
A study testing Para-Sartorial Compartments (PACS) Block, Femoral Triangle Block (FTB) and Infiltration between popliteal artery and capsule of the knee (IPACK) block in people with Post-operative Pain and Anesthesia, Local, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Total knee replacement surgery can be associated with a significant postoperative pain burden and an inability to mobilize adequately, which can lead to the failure of the ambulatory course. Indeed, early mobilization is beneficial in this context in order to prevent complications related to immobility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Pain, Anesthesia, Local
- What is being tested?
- Para-Sartorial Compartments (PACS) Block, Femoral Triangle Block (FTB) and Infiltration between popliteal artery and capsule of the knee (IPACK) block
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteCanada
- Study dates
- 2 Oct 2023to 31 Mar 2025
- Phase
- Interventional
- 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 and over, requiring a primary total knee arthroplasty
- 'American Society of Anesthesiologists' classification 1 to 3
Who cannot join
- Refusal or unable to consent
- Contraindications to a peripheral nerve block;
- Inability to communicate with the healthcare team or the research team;
- Inability to understand follow-up instructions or questionnaires;
- Chronic pain requiring the intake of the equivalent of more than 60 mg of morphine daily;
- Pregnancy;
- Patients weighing less than 50 kg (to limit the risk of intoxication with local anesthetics).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
About this study
Official title: Evaluation of the Analgesic Benefit of Adding the Blocks of the Intermediate and Medial Femoral Cutaneous Nerves in Addition to the Femoral Triangle Block for Postoperative Analgesia After a Knee Replacement Surgery: A Randomized Controlled Clinical Trial
Total knee replacement surgery can be associated with a significant postoperative pain burden and an inability to mobilize adequately, which can lead to the failure of the ambulatory course.
Indeed, early mobilization is beneficial in this context in order to prevent complications related to immobility.
Read more
The optimization of postoperative analgesia is therefore a key issue for the success of this intervention in an outpatient setting or during a short-term hospitalization since an adequate pain relief facilitate the earlier mobilization of the operated joint. Modern postoperative analgesia protocols recommend a multimodal approach, including the use of acetaminophen, anti-inflammatories, opioids and others as well as the use of nerve blocks.
Some nerve blocks used for total knee replacement surgery, such as the femoral nerve block, do not preserve the motor skills of the operated limb, which may alter the clinical trajectory due to delayed mobilization due to weakening of the quadriceps, one of the extensor muscles of the knee. Currently, one of the blocks used to spare the motor functions is the block of the femoral triangle.
Unfortunately, this block of the femoral triangle does not fully cover the skin component of the surgical incision used for a total knee arthroplasty. A solution to obtain a better quality of pain relief at the level of the cutaneous incision would be to add a block of the para-sartorial compartment, which makes it possible to cover the nerve territories not covered by the femoral triangle block.
The hypothesis of this study is that the addition of the para-sartorial compartments (PACS) block, which aims to block the intermediate cutaneous femoral nerve, will improve the postoperative analgesia after total knee replacement surgery, compared to the classical isolated approach of the femoral triangle block (FTB).
Read the detailed description
Despite many advances, the postoperative analgesia offered by the present techniques remains imperfect, the femoral triangle block does not make it possible to completely cover the cutaneous component of the classic midline incision used for a total knee arthroplasty. This incision would fall more under the anterior cutaneous femoral nerves, more specifically the intermediate and medial cutaneous femoral nerves. A recently described approach offers the prospect of better covering this skin incision, by specifically blocking these nerves using the same needle path as for the femoral triangle block. Although the feasibility of this approach has been studied in healthy volunteers and in a few clinical cases, no randomized controlled study has been conducted to determine whether the addition of cutaneous femoral nerve blocks offers an analgesic benefit in the population undergoing total knee replacement surgery. This is therefore necessary in order to assess whether this approach improves the clinical trajectory of patients receiving a total knee arthroplasty.
- Conditions
- Post-operative Pain, Anesthesia, Local
- Being tested
- Para-Sartorial Compartments (PACS) Block, Femoral Triangle Block (FTB), Infiltration between popliteal artery and capsule of the knee (IPACK) block
- Keywords
- total knee replacement surgery, para-sartorial compartments block, femoral triangle block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Para-Sartorial Compartments (PACS) BlockProcedure or surgery
This intervention was selected because it has the potential to optimize analgesia by skin coverage of the upper third of the surgical incision. The intervention will be performed as follows:
- The intermediate femoral cutaneous nerve will be visualized at the supralateral level of the sartorius muscle, in a duplicature of the fascia lata.
- The needle will be inserted at the same puncture site as for the femoral triangle block, with a latero-medial orientation in the plane (intracanalar compartment).
- In addition to the injection performed in the femoral triangle, two injections of 5 mL of 0.5% ropivacaine + epi 1:400 000 will be performed in addition, below the sartorius muscle (subsartorial compartment) and above the sartorius muscle (suprasartorial compartment).
Femoral Triangle Block (FTB)Procedure or surgery
- The high frequency linear ultrasound probe will be positioned midway between the superior edge of the patella and the anterosuperior iliac spine. It will then be moved to visualize the apex of the femoral triangle, confirmed by visualization of the sartorius muscle laterally and the long adductor medially.
- The needle will be inserted with a latero-medial orientation in the plane.
- The initial injection will be a single injection of 15 ml of 0.5% ropivacaine + epi 1:400 000 under the sartorius muscle, lateral to the femoral artery, at the level of the apex of the femoral triangle.
Infiltration between popliteal artery and capsule of the knee (IPACK) blockProcedure or surgery
It will be performed in order to block the sensory branches of the innervation posterior to the knee with 15 ml of ropivacaine 0.3% + epi 1:400 000.
| Study group | Role | What they receive |
|---|---|---|
| Para-Sartorial Compartment (PACS) Block + Femoral Triangle Block (FTB) + IPACK block | Experimental | In addition to the injection performed in the femoral triangle, two injections of 5 mL of 0.5% ropivacaine + epi 1:400 000 will be performed below the sartorius muscle (subsartorial compartment) and above the sartorius muscle (suprasartorial compartment).
For all patients, an infiltration between popliteal artery and capsule of the knee block (IPACK) will be performed concomitantly, in order to block the sensory branches of the innervation posterior to the knee with 15 ml of ropivacaine 0.3% + epi 1:400 000. Receives: Procedure: Para-Sartorial Compartments (PACS) Block; Procedure: Femoral Triangle Block (FTB); Procedure: Infiltration between popliteal artery and capsule of the knee (IPACK) block |
| Femoral Triangle Block (FTB) + IPACK block | Active comparator | This block is currently the most used in practice and is considered a standard of care. It consists of a single injection of 15 ml of 0.5% ropivacaine + epi 1:400 000 under the sartorius muscle, lateral to the femoral artery, at the level of the apex of the femoral triangle
For all patients, an infiltration between popliteal artery and capsule of the knee block (IPACK) will be performed concomitantly, in order to block the sensory branches of the innervation posterior to the knee with 15 ml of ropivacaine 0.3% + epi 1:400 000. Receives: Procedure: Femoral Triangle Block (FTB); Procedure: Infiltration between popliteal artery and capsule of the knee (IPACK) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of the postoperative pain
The Pain Intensity short form questionnaire (PROMIS) is universal rather than disease-specific. The first two items in the Pain Intensity item bank assess pain intensity utilizing a 24-hour recall period (items include the phrase "the past 24 hours") while the last item asks patient to rate their pain intensity "right now."
Measured: 24 hours after the surgery
Secondary outcomes (8)
Intensity of the postoperative pain
The Pain Intensity short form questionnaire (PROMIS) is universal rather than disease-specific. The first two items in the Pain Intensity item bank assess pain intensity utilizing a 7-day recall period (items include the phrase "the past 7 days") while the last item asks patient to rate their pain intensity "right now."
Measured: 7 days after the surgery
Total morphine consumption
Measured: 24 hours after the surgery
Time between the end of surgery and the first opioid dose
Measured: 24 hours after the surgery
Pain levels
Postoperative pain levels will be assessed every 6 hours for the first 24 hours after the surgery using a numerical scale where 0 = no pain and 10 = worst pain imaginable
Measured: 6 hours, 12 hours, 18 hours and 24 hours after the surgery
Complications
The rate of complications or adverse effects during the first 24 hours will be assessed, such as local anesthetic toxicity, nausea, vomiting, pruritus and acute urinary retention.
Measured: 24 hours after the surgery
Quality of sleep
The quality of sleep of the patient will be evaluated, rated on a scale where 0 = insomnia and 10 = excellent quality sleep.
Measured: 24 hours after the surgery
Quality of postoperative recovery
QoR15 is a valid questionnaire to measure the quality of recovery after surgery and anaesthesia, which includes 15 questions. Each of the 15 items are scored by the patient from 0 (worst score) to 10 (optimal score), giving a lowest possible score of 0 (worst outcome), and a highest possible score of 150 (optimal outcome).
Measured: Change between baseline (day 0) and 7 days after the surgery
Patient's satisfaction
The satisfaction of the patient will be evaluated, rated on a scale where 0 = completely dissatisfied and 10 = fully satisfied.
Measured: 24 hours and 7 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start2 Oct 2023
- Primary completion24 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, prospective superiority study, randomized controlled, triple blind
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxim Roy, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038851
- Sponsor's protocol ID
- 23.116
- Status last verified
- Jul 2025
- First submitted
- 29 Aug 2023
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Benefit of Adding the Blocks of the Intermediate and Medial Femoral Cutaneous Nerves in Addition to the Femoral Triangle Block for Postoperative Analgesia After a Knee Replacement Surgery: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06038851
- Acronym / sponsor ID
- 23.116
- Conditions
- Post-operative Pain, Anesthesia, Local
- Keywords
- total knee replacement surgery, para-sartorial compartments block, femoral triangle block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 15 Sep 2023 (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.
Total knee replacement surgery can be associated with a significant postoperative pain burden and an inability to mobilize adequately, which can lead to the failure of the ambulatory course.
Indeed, early mobilization is beneficial in this context in order to prevent complications related to immobility.
The optimization of postoperative analgesia is therefore a key issue for the success of this intervention in an outpatient setting or during a short-term hospitalization since an adequate pain relief facilitate the earlier mobilization of the operated joint. Modern postoperative analgesia protocols recommend a multimodal approach, including the use of acetaminophen, anti-inflammatories, opioids and others as well as the use of nerve blocks.
Some nerve blocks used for total knee replacement surgery, such as the femoral nerve block, do not preserve the motor skills of the operated limb, which may alter the clinical trajectory due to delayed mobilization due to weakening of the quadriceps, one of the extensor muscles of the knee. Currently, one of the blocks used to spare the motor functions is the block of the femoral triangle.
Unfortunately, this block of the femoral triangle does not fully cover the skin component of the surgical incision used for a total knee arthroplasty. A solution to obtain a better quality of pain relief at the level of the cutaneous incision would be to add a block of the para-sartorial compartment, which makes it possible to cover the nerve territories not covered by the femoral triangle block.
The hypothesis of this study is that the addition of the para-sartorial compartments (PACS) block, which aims to block the intermediate cutaneous femoral nerve, will improve the postoperative analgesia after total knee replacement surgery, compared to the classical isolated approach of the femoral triangle block (FTB).
Detailed description
Despite many advances, the postoperative analgesia offered by the present techniques remains imperfect, the femoral triangle block does not make it possible to completely cover the cutaneous component of the classic midline incision used for a total knee arthroplasty. This incision would fall more under the anterior cutaneous femoral nerves, more specifically the intermediate and medial cutaneous femoral nerves. A recently described approach offers the prospect of better covering this skin incision, by specifically blocking these nerves using the same needle path as for the femoral triangle block. Although the feasibility of this approach has been studied in healthy volunteers and in a few clinical cases, no randomized controlled study has been conducted to determine whether the addition of cutaneous femoral nerve blocks offers an analgesic benefit in the population undergoing total knee replacement surgery. This is therefore necessary in order to assess whether this approach improves the clinical trajectory of patients receiving a total knee arthroplasty.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, prospective superiority study, randomized controlled, triple blind
| Arm | Type | Receives |
|---|---|---|
| Para-Sartorial Compartment (PACS) Block + Femoral Triangle Block (FTB) + IPACK block | Experimental | Procedure: Para-Sartorial Compartments (PACS) Block, Procedure: Femoral Triangle Block (FTB), Procedure: Infiltration between popliteal artery and capsule of the knee (IPACK) blockIn addition to the injection performed in the femoral triangle, two injections of 5 mL of 0.5% ropivacaine + epi 1:400 000 will be performed below the sartorius muscle (subsartorial compartment) and above the sartorius muscle (suprasartorial compartment). For all patients, an infiltration between popliteal artery and capsule of the knee block (IPACK) will be performed concomitantly, in order to block the sensory branches of the innervation posterior to the knee with 15 ml of ropivacaine 0.3% + epi 1:400 000. |
| Femoral Triangle Block (FTB) + IPACK block | Active comparator | Procedure: Femoral Triangle Block (FTB), Procedure: Infiltration between popliteal artery and capsule of the knee (IPACK) blockThis block is currently the most used in practice and is considered a standard of care. It consists of a single injection of 15 ml of 0.5% ropivacaine + epi 1:400 000 under the sartorius muscle, lateral to the femoral artery, at the level of the apex of the femoral triangle For all patients, an infiltration between popliteal artery and capsule of the knee block (IPACK) will be performed concomitantly, in order to block the sensory branches of the innervation posterior to the knee with 15 ml of ropivacaine 0.3% + epi 1:400 000. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and over, requiring a primary total knee arthroplasty
- 'American Society of Anesthesiologists' classification 1 to 3
Key exclusion criteria (7 listed)
- Refusal or unable to consent
- Contraindications to a peripheral nerve block;
- Inability to communicate with the healthcare team or the research team;
- Inability to understand follow-up instructions or questionnaires;
- Chronic pain requiring the intake of the equivalent of more than 60 mg of morphine daily;
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 |
|---|---|---|
| Para-Sartorial Compartments (PACS) BlockThis intervention was selected because it has the potential to optimize analgesia by skin coverage of the upper third of the surgical incision. The intervention will be performed as follows: * The intermediate femoral cutaneous nerve will be visualized at the supralateral level of the sartorius muscle, in a duplicature of the fascia lata. * The needle will be inserted at the same puncture site as for the femoral triangle block, with a latero-medial orientation in the plane (intracanalar compartment). * In addition to the injection performed in the femoral triangle, two injections of 5 mL of 0.5% ropivacaine + epi 1:400 000 will be performed in addition, below the sartorius muscle (subsartorial compartment) and above the sartorius muscle (suprasartorial compartment). | Procedure or surgery | Para-Sartorial Compartment (PACS) Block + Femoral Triangle Block (FTB) + IPACK block |
| Femoral Triangle Block (FTB)* The high frequency linear ultrasound probe will be positioned midway between the superior edge of the patella and the anterosuperior iliac spine. It will then be moved to visualize the apex of the femoral triangle, confirmed by visualization of the sartorius muscle laterally and the long adductor medially. * The needle will be inserted with a latero-medial orientation in the plane. * The initial injection will be a single injection of 15 ml of 0.5% ropivacaine + epi 1:400 000 under the sartorius muscle, lateral to the femoral artery, at the level of the apex of the femoral triangle. | Procedure or surgery | Femoral Triangle Block (FTB) + IPACK block, Para-Sartorial Compartment (PACS) Block + Femoral Triangle Block (FTB) + IPACK block |
| Infiltration between popliteal artery and capsule of the knee (IPACK) blockIt will be performed in order to block the sensory branches of the innervation posterior to the knee with 15 ml of ropivacaine 0.3% + epi 1:400 000. | Procedure or surgery | Femoral Triangle Block (FTB) + IPACK block, Para-Sartorial Compartment (PACS) Block + Femoral Triangle Block (FTB) + IPACK block |
Primary outcome
Intensity of the postoperative pain
Time frame: 24 hours after the surgery
The Pain Intensity short form questionnaire (PROMIS) is universal rather than disease-specific. The first two items in the Pain Intensity item bank assess pain intensity utilizing a 24-hour recall period (items include the phrase "the past 24 hours") while the last item asks patient to rate their pain intensity "right now."
8 secondary outcomes
Intensity of the postoperative pain
Time frame: 7 days after the surgery
Total morphine consumption
Time frame: 24 hours after the surgery
Time between the end of surgery and the first opioid dose
Time frame: 24 hours after the surgery
Pain levels
Time frame: 6 hours, 12 hours, 18 hours and 24 hours after the surgery
Complications
Time frame: 24 hours after the surgery
Quality of sleep
Time frame: 24 hours after the surgery
Quality of postoperative recovery
Time frame: Change between baseline (day 0) and 7 days after the surgery
Patient's satisfaction
Time frame: 24 hours and 7 days after the surgery
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 3 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Maxim Roy, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Para-Sartorial Compartments (PACS) Block, Femoral Triangle Block (FTB) and Infiltration between popliteal artery and capsule of the knee (IPACK) block in people with Post-operative Pain and Anesthesia, Local, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 2 inclusion and 7 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 3 Jul 2025. 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 Canada. 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.
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?
Intensity of the postoperative pain (time frame: 24 hours after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2025.