Primary Total Knee ArthroplastyQuITONCT04499716
Quadriblock Versus "IPACK + Femoral Triangle Block + Obturator Nerve Block" in Total Knee Arthroplasty
A study testing IPACK, Femoral triangle block and Obturator nerve block in people with Primary Total Knee Arthroplasty, run by Clinique Medipole Garonne at 1 site in France.
Trial summary
Total knee arthroplasty (TKA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery. Postoperative pain management requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Total Knee Arthroplasty
- What is being tested?
- IPACK, Femoral triangle block and Obturator nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2020to 7 May 2021
- 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 older,
- Primary total knee arthroplasty
- Consent for participation,
- Affiliation to a social security system
Who cannot join
- Preoperative morphine use
- Chronic pain syndrome
- Contraindication to any drugs used in the protocol (paracetamol, ketoprofen, oxynorm, propofol, ketamine, ropivacaine)
- Valgus > 9°
- Pregnant or breastfeeding women
- Patients under protection of the adults (guardianship, curators or safeguard of justice)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quadriblock Versus "IPACK + Femoral Triangle Block + Obturator Nerve Block" in Total Knee Arthroplasty: a Randomized Controlled Clinical Trial
Total knee arthroplasty (TKA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery.
Postoperative pain management requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). For optimal pain management, several peripheral nerve blocks should be associated. Thus, a recent study shows that the combination of IPACK, femoral triangle and obturator nerve blocks (ITO blocks) provides an effective pain control after TKA.
Read more
The hypothesis of this study is that a quadruple nerve block combining femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks (quadri-block) could improve analgesia after TKA.
The main objective of this monocenter, prospective, randomized, open-label, controlled trial is to assess the effect of quadri-block on morphine consumption after TKA compared to ITO blocks.
Read the detailed description
In the pre-anaesthesia room, after the implementation of classical monitoring with an oxygen mask and a peripheral venous catheter, all patients will receive an antibioprophylaxis according to SFAR (French Society of Anesthesia \& Intensive Care Medecine) recommendations and injection of 10 mg of IV dexamethasone.
The patients will be then randomized in 2 groups:
- ITO group (usual technique): IPACK combined to femoral triangle and obturator nerve blocks
- Quadriblock group (experimental technique): femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks.
An experienced anesthetist will perform ultrasound-guided blocks 30 minutes before surgery with ropivacaine 0.3%, total volume of 70 ml.
In the operating room, general anesthesia will be induced by intravenous ketamine (0.4 mg/kg) and propofol (3 mg/kg). Anesthesia will be maintained with propofol.
Postoperative analgesia protocol :
- Multimodal analgesia will be instituted from the end of the surgery by the administration of paracetamol (1 g) and ketoprofen (100 mg).
- In post-anesthesia care unit (PACU): oxynorm titration if VRS (pain score) >3 according to the centre's usual care.
- In ward: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen (400 mg, 3 times a day); oxynorm (10 mg, lockout interval: 4 h) if VRS (pain score) >3.
- Conditions
- Primary Total Knee Arthroplasty
- Being tested
- IPACK, Femoral triangle block, Obturator nerve block, Femoral nerve block, Sciatic nerve block
- Keywords
- Knee arthroplasty, Regional anesthesia, Ropivacaine, Postoperative analgesia, Pain management, Opioids
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPACKProcedure or surgery
25 milliliters of ropivacaine 0.3% will be injected between popliteal artery and femur.
Femoral triangle blockProcedure or surgery
25 milliliters of ropivacaine 0.3% will be injected on the lateral side of the femoral artery at the distal part of the femoral triangle.
Obturator nerve blockProcedure or surgery
20 milliliters of ropivacaine 0.3% will be injected between the adductor magnus and adductor brevis muscles and between the adductor brevis muscle the pectineus.
Femoral nerve blockProcedure or surgery
20 milliliters of ropivacaine 0.3% will be injected in supine position under the fascia iliaca lateral to the femoral artery.
Sciatic nerve blockProcedure or surgery
25 milliliters of ropivacaine 0.3% will be injected in prone position in the subgluteal space by lateral approach.
Lateral femoral cutaneous nerve blockProcedure or surgery
5 milliliters of ropivacaine 0.3% will be injected laterally to the sartorius muscle.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: ITO group | Active comparator | Arm 1: IPACK combined with femoral triangle and obturator nerve blocks Receives: Procedure: IPACK; Procedure: Femoral triangle block; Procedure: Obturator nerve block |
| Arm 2 : Quadri-block group | Experimental | Arm 2 : Femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks Receives: Procedure: Obturator nerve block; Procedure: Femoral nerve block; Procedure: Sciatic nerve block; Procedure: Lateral femoral cutaneous nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia, defined by the morphine consumption in the first 48 hours post-surgery.
Total amount of oxynorm (mg) administered during the first 48 hours post-surgery.
Measured: 48 hours
Secondary outcomes (6)
Postoperative pain: Verbal Rating Scale (VRS)
Pain will be assessed every 6 hours using a Verbal Rating Scale (VRS) ranging from 0 to 10 (0=no pain, 10=worst possible pain).
Measured: 48 hours
Oxynorm consumption in the first 24 hours post-surgery
Total amount of oxynorm (mg) administered during the first 24 hours post-surgery.
Measured: 24 hours
Ability to walk
0: unable to get up; 1: able to get up but not to walk; 2: walk <50 m; 3: walk > 50 m
Measured: 48 hours
Quadricep mobilization
0: paralysis; 1: paresis, 2: normal contraction
Measured: 48 hours
Foot elevator muscle mobilization
0: paralysis; 1: paresis; 2: normal contraction
Measured: 48 hours
Side effects of opioids
Collect side effects associated with oxynorm : nausea or vomiting, drowsiness, constipation, urinary retention, itching, disorientation.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start8 Dec 2020
- Primary completion7 May 2021
- Study completion7 May 2021
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 Primary Total Knee ArthroplastyStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Medipole Garonne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499716
- Sponsor's protocol ID
- 2020/04
- Acronym
- QuITO
- Status last verified
- Jul 2020
- First submitted
- 31 Jul 2020
- Last updated
- 7 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marty P, Chassery C, Rontes O, Vuillaume C, Basset B, Merouani M, Marquis C, De Lussy A, Ferre F, Naudin C, Joshi GP, Delbos A. Combined proximal or distal nerve blocks for postoperative analgesia after total knee arthroplasty: a randomised controlled trial. Br J Anaesth. 2022 Sep;129(3):427-434. doi: 10.1016/j.bja.2022.05.024. Epub 2022 Jun 28.
PubMed 35773028
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadriblock Versus "IPACK + Femoral Triangle Block + Obturator Nerve Block" in Total Knee Arthroplasty: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04499716
- Acronym / sponsor ID
- QuITO / 2020/04
- Conditions
- Primary Total Knee Arthroplasty
- Keywords
- Knee arthroplasty, Regional anesthesia, Ropivacaine, Postoperative analgesia, Pain management, Opioids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Clinique Medipole GaronneUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 5 Aug 2020 (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 arthroplasty (TKA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery.
Postoperative pain management requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). For optimal pain management, several peripheral nerve blocks should be associated. Thus, a recent study shows that the combination of IPACK, femoral triangle and obturator nerve blocks (ITO blocks) provides an effective pain control after TKA.
The hypothesis of this study is that a quadruple nerve block combining femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks (quadri-block) could improve analgesia after TKA.
The main objective of this monocenter, prospective, randomized, open-label, controlled trial is to assess the effect of quadri-block on morphine consumption after TKA compared to ITO blocks.
Detailed description
In the pre-anaesthesia room, after the implementation of classical monitoring with an oxygen mask and a peripheral venous catheter, all patients will receive an antibioprophylaxis according to SFAR (French Society of Anesthesia \& Intensive Care Medecine) recommendations and injection of 10 mg of IV dexamethasone.
The patients will be then randomized in 2 groups:
- ITO group (usual technique): IPACK combined to femoral triangle and obturator nerve blocks
- Quadriblock group (experimental technique): femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks.
An experienced anesthetist will perform ultrasound-guided blocks 30 minutes before surgery with ropivacaine 0.3%, total volume of 70 ml.
In the operating room, general anesthesia will be induced by intravenous ketamine (0.4 mg/kg) and propofol (3 mg/kg). Anesthesia will be maintained with propofol.
Postoperative analgesia protocol :
- Multimodal analgesia will be instituted from the end of the surgery by the administration of paracetamol (1 g) and ketoprofen (100 mg).
- In post-anesthesia care unit (PACU): oxynorm titration if VRS (pain score) >3 according to the centre's usual care.
- In ward: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen (400 mg, 3 times a day); oxynorm (10 mg, lockout interval: 4 h) if VRS (pain score) >3.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: ITO group | Active comparator | Procedure: IPACK, Procedure: Femoral triangle block, Procedure: Obturator nerve blockArm 1: IPACK combined with femoral triangle and obturator nerve blocks |
| Arm 2 : Quadri-block group | Experimental | Procedure: Obturator nerve block, Procedure: Femoral nerve block, Procedure: Sciatic nerve block, Procedure: Lateral femoral cutaneous nerve blockArm 2 : Femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older,
- Primary total knee arthroplasty
- Consent for participation,
- Affiliation to a social security system
Key exclusion criteria (6 listed)
- Preoperative morphine use
- Chronic pain syndrome
- Contraindication to any drugs used in the protocol (paracetamol, ketoprofen, oxynorm, propofol, ketamine, ropivacaine)
- Valgus > 9°
- Pregnant or breastfeeding women
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 |
|---|---|---|
| IPACK25 milliliters of ropivacaine 0.3% will be injected between popliteal artery and femur. | Procedure or surgery | Arm 1: ITO group |
| Femoral triangle block25 milliliters of ropivacaine 0.3% will be injected on the lateral side of the femoral artery at the distal part of the femoral triangle. | Procedure or surgery | Arm 1: ITO group |
| Obturator nerve block20 milliliters of ropivacaine 0.3% will be injected between the adductor magnus and adductor brevis muscles and between the adductor brevis muscle the pectineus. | Procedure or surgery | Arm 1: ITO group, Arm 2 : Quadri-block group |
| Femoral nerve block20 milliliters of ropivacaine 0.3% will be injected in supine position under the fascia iliaca lateral to the femoral artery. | Procedure or surgery | Arm 2 : Quadri-block group |
| Sciatic nerve block25 milliliters of ropivacaine 0.3% will be injected in prone position in the subgluteal space by lateral approach. | Procedure or surgery | Arm 2 : Quadri-block group |
| Lateral femoral cutaneous nerve block5 milliliters of ropivacaine 0.3% will be injected laterally to the sartorius muscle. | Procedure or surgery | Arm 2 : Quadri-block group |
Primary outcome
Postoperative analgesia, defined by the morphine consumption in the first 48 hours post-surgery.
Time frame: 48 hours
Total amount of oxynorm (mg) administered during the first 48 hours post-surgery.
6 secondary outcomes
Postoperative pain: Verbal Rating Scale (VRS)
Time frame: 48 hours
Oxynorm consumption in the first 24 hours post-surgery
Time frame: 24 hours
Ability to walk
Time frame: 48 hours
Quadricep mobilization
Time frame: 48 hours
Foot elevator muscle mobilization
Time frame: 48 hours
Side effects of opioids
Time frame: 48 hours
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 7 Jun 2021.
- Derived from this study: PubMed 35773028Marty P, Chassery C, Rontes O, Vuillaume C, Basset B, Merouani M, Marquis C, De Lussy A, Ferre F, Naudin C, Joshi GP, Delbos A. Combined proximal or distal nerve blocks for postoperative analgesia after total knee arthroplasty: a randomised controlled trial. Br J Anaesth. 2022 Sep;129(3):427-434. doi: 10.1016/j.bja.2022.05.024. Epub 2022 Jun 28.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPACK, Femoral triangle block and Obturator nerve block in people with Primary Total Knee Arthroplasty, run by Clinique Medipole Garonne at 1 site in France.
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 4 inclusion and 6 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 7 Jun 2021. 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 France. 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?
Postoperative analgesia, defined by the morphine consumption in the first 48 hours post-surgery. (time frame: 48 hours). 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 NCT04499716, 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 7 Jun 2021.