Hip Arthroplasty, TotalSOSBIFSINCT06982625
Supra Inguinal Fascia Iliaca Block as Rescue Analgesia Following Total Hip Arthroplasty
A study testing Ultrasound guided supra inguinal fascia iliaca block and Surgical and anesthetic protocol in people with Hip Arthroplasty, Total and Post Operative Pain, Acute, run by Institut Mutualiste Montsouris at 1 site in France.
Trial summary
Hip replacement surgery is one of the most commonly performed surgical procedures in France, with approximately 150,000 procedures per year. Postoperative recovery has significantly improved in recent years, enabling faster rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthroplasty, Total, Post Operative Pain, Acute, Nerve Block
- What is being tested?
- Ultrasound guided supra inguinal fascia iliaca block and Surgical and anesthetic protocol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- patient scheduled for a primary total hip arthroplasty under general anesthesia,
- written informed consent.
- Non inclusion criteria:
- contra indication to ropivacaine
- vulnerable person
Who cannot join
- per-operative complication making wheight-bearing and walking contra-indicated.
- patient without significant pain post-operatively.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Mutualiste Montsouris
Paris, 75014
Abderrahmen Bargaoui, Dr
About this study
Hip replacement surgery is one of the most commonly performed surgical procedures in France, with approximately 150,000 procedures per year. Postoperative recovery has significantly improved in recent years, enabling faster rehabilitation.
Although generally considered moderately painful, hip replacement surgery can, in some difficult-to-predict cases, lead to severe postoperative pain, requiring high doses of morphine, which may cause side effects and delay recovery.
Read more
In other surgical procedures, regional anesthesia (nerve blocks) has been successfully used for pain relief. However, its effectiveness after hip replacement surgery has not yet been fully proven.
A recent regional anesthesia technique-the Supra-Inguinal Fascia Iliaca Block (SIFIB)-which numbs a significant portion of the nerves around the hip, has recently been developed.
When performed in all patients undergoing hip arthroplasty, the benefit of this technique could not be demonstrated. In addition, this technique may lead to transcient muscle blockade, wich also can delay recovery.
In order to limit the use of nerve blocks to painful patients, we designed this study where the nerve block is performed only in patients experiencing significant paint after surgery.
In conclusion, this study aims to assess the benefits of performing a rescue SIFIB in the recovery room for patients who experience significant postoperative pain after hip replacement surgery. The evaluation will focus on pain relief and ability to walk.
No new treatment is being tested. The technique uses a commonly administered local anesthetic to numb the nerves.
- Being tested
- Ultrasound guided supra inguinal fascia iliaca block, Placebo Injection, Surgical and anesthetic protocol
- Keywords
- Total hip arthroplasty, Regional anesthesia, Nerve blocks, Supra-inguinal fascia iliaca block, Enhanced recovery after surgery, Acute post-operative pain, Rescue analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided supra inguinal fascia iliaca blockProcedure or surgery
The ultrasound probe is placed in a cephalo-caudal orientation, over the inguinal ligament, lateral to the femoral nerve. The iliacus muscle, which is covered caudally by the sartorius muscle and cephalically by the internal oblique muscle, is visualized in depth. Between these two muscles, an area is identified where the iliacus muscle is covered only by subcutaneous tissue. The needle is introduced in a cranio-caudal direction, and the injection is initiated in this area, beneath the fascia iliaca. The needle then advances through the space created by the injection, as far as possible in a cephalic direction, beneath the internal oblique muscle. An injection of 40 ml of 0.1% ropivacaine is administered.
Placebo InjectionProcedure or surgery
Five milliliters of saline are injected subcutaneously under ultrasound guidance
Surgical and anesthetic protocolProcedure or surgery
All patients receive standard general anesthesia:
- Induction of anesthesia by sufentanil, ketamine, propofol and tracrium if needed,
- Maintenance of anesthesia by sevoflurane and sufentanil if needed,
- Prevention of PONV by dexamethasone and droperidol,
- Post-operative analgesia by paracetamol, ketoprofene, nefopam, as indicated. Total hip arthroplasty is performed by anterior or postero-lateral approach, depending on surgeon preference.
In the post-anesthesia care unit, if numerical pain rating scale at rest is >=4, patients are randomized to receive experimental or placebo intervention.
| Study group | Role | What they receive |
|---|---|---|
| SIFIB group | Experimental | The ultrasound probe is placed in a cephalo-caudal orientation, over the inguinal ligament, lateral to the femoral nerve. The iliacus muscle, which is covered caudally by the sartorius muscle and cephalically by the internal oblique muscle, is visualized in depth. Between these two muscles, an area is identified where the iliacus muscle is covered only by subcutaneous tissue. The needle is introduced in a cranio-caudal direction, and the injection is initiated in this area, beneath the fascia iliaca. The needle then advances through the space created by the injection, as far as possible in a cephalic direction, beneath the internal oblique muscle. An injection of 40 ml of 0.1% ropivacaine is administered. Receives: Procedure: Ultrasound guided supra inguinal fascia iliaca block; Procedure: Surgical and anesthetic protocol |
| Placebo group | Sham comparator | Five milliliters of saline are injected subcutaneously under ultrasound guidance Receives: Procedure: Placebo Injection; Procedure: Surgical and anesthetic protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome
Composite outcome is validated if all of these 3 items are validated:
- numerical pain rating scale (from 0 to 10) at rest is < 4,
- and intravenous morphine < 0,1 mg/kg,
- and first mobilization successful. First mobilization is validated if patient can stand up, walk 5 meters then sit down in a wheelchair.
Measured: 2 hours post operatively
Secondary outcomes (4)
Morphine consumption
oral morphine equivalent needings
Measured: 24 hours post operatively
Pain evaluation
Numerical pain rating scale (0-10=) at rest Numerical rating scale for pain is described as a scale from a minimum of 0, associated with no pain, to a maximum of 10, associated with the worst possible pain.
Measured: 6, 12 and 24 hours post operatively
Length of hospital stay
Number of in-hospital post operative nights
Measured: An average of 2 to 3 days up to 1 week
Patient satisfaction
Patient satisfaction assessment on pain management, using a 5-degrees Likert scale.
(1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start22 Sep 2025
- Primary completion22 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hip Arthroplasty, TotalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, assessor and patient blinded, placebo controlled
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abderrahmen BARGAOUI, Institut Mutualiste Montsouris
- Investigators
- Abderrahmen BARGAOUI, MD, Principal investigator, Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982625
- Sponsor's protocol ID
- ANESTH-03-2024
- Other IDs
- 2024-A02290-47
- Acronym
- SOSBIFSI
- Status last verified
- Sep 2025
- First submitted
- 29 Apr 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.
PubMed 28059869Zhang XY, Ma JB. The efficacy of fascia iliaca compartment block for pain control after total hip arthroplasty: a meta-analysis. J Orthop Surg Res. 2019 Jan 25;14(1):33. doi: 10.1186/s13018-018-1053-1.
PubMed 30683117Changjun C, Xin Z, Yue L, Liyile C, Pengde K. Key Elements of Enhanced Recovery after Total Joint Arthroplasty: A Reanalysis of the Enhanced Recovery after Surgery Guidelines. Orthop Surg. 2023 Mar;15(3):671-678. doi: 10.1111/os.13623. Epub 2023 Jan 3.
PubMed 36597677Bloc S, Alfonsi P, Belbachir A, Beaussier M, Bouvet L, Campard S, Campion S, Cazenave L, Diemunsch P, Di Maria S, Dufour G, Fabri S, Fletcher D, Garnier M, Godier A, Grillo P, Huet O, Joosten A, Lasocki S, Le Guen M, Le Sache F, Macquer I, Marquis C, de Montblanc J, Maurice-Szamburski A, Nguyen YL, Ruscio L, Zieleskiewicz L, Caillard A, Weiss E. Guidelines on perioperative optimization protocol for the adult patient 2023. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101264. doi: 10.1016/j.accpm.2023.101264. Epub 2023 Jun 7.
PubMed 37295649Anger M, Valovska T, Beloeil H, Lirk P, Joshi GP, Van de Velde M, Raeder J; PROSPECT Working Group* and the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guideline for total hip arthroplasty: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Aug;76(8):1082-1097. doi: 10.1111/anae.15498. Epub 2021 May 20.
PubMed 34015859Memtsoudis SG, Cozowicz C, Bekeris J, Bekere D, Liu J, Soffin EM, Mariano ER, Johnson RL, Go G, Hargett MJ, Lee BH, Wendel P, Brouillette M, Kim SJ, Baaklini L, Wetmore DS, Hong G, Goto R, Jivanelli B, Athanassoglou V, Argyra E, Barrington MJ, Borgeat A, De Andres J, El-Boghdadly K, Elkassabany NM, Gautier P, Gerner P, Gonzalez Della Valle A, Goytizolo E, Guo Z, Hogg R, Kehlet H, Kessler P, Kopp S, Lavand'homme P, Macfarlane A, MacLean C, Mantilla C, McIsaac D, McLawhorn A, Neal JM, Parks M, Parvizi J, Peng P, Pichler L, Poeran J, Poultsides L, Schwenk ES, Sites BD, Stundner O, Sun EC, Viscusi E, Votta-Velis EG, Wu CL, YaDeau J, Sharrock NE. Peripheral nerve block anesthesia/analgesia for patients undergoing primary hip and knee arthroplasty: recommendations from the International Consensus on Anesthesia-Related Outcomes after Surgery (ICAROS) group based on a systematic review and meta-analysis of current literature. Reg Anesth Pain Med. 2021 Nov;46(11):971-985. doi: 10.1136/rapm-2021-102750. Epub 2021 Aug 25.
PubMed 34433647Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
PubMed 23392233
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supra Inguinal Fascia Iliaca Block as Rescue Analgesia Following Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06982625
- Acronym / sponsor ID
- SOSBIFSI / ANESTH-03-2024
- Keywords
- Total hip arthroplasty, Regional anesthesia, Nerve blocks, Supra-inguinal fascia iliaca block, Enhanced recovery after surgery, Acute post-operative pain, Rescue analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 22 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 May 2025 (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.
Hip replacement surgery is one of the most commonly performed surgical procedures in France, with approximately 150,000 procedures per year. Postoperative recovery has significantly improved in recent years, enabling faster rehabilitation.
Although generally considered moderately painful, hip replacement surgery can, in some difficult-to-predict cases, lead to severe postoperative pain, requiring high doses of morphine, which may cause side effects and delay recovery.
In other surgical procedures, regional anesthesia (nerve blocks) has been successfully used for pain relief. However, its effectiveness after hip replacement surgery has not yet been fully proven.
A recent regional anesthesia technique-the Supra-Inguinal Fascia Iliaca Block (SIFIB)-which numbs a significant portion of the nerves around the hip, has recently been developed.
When performed in all patients undergoing hip arthroplasty, the benefit of this technique could not be demonstrated. In addition, this technique may lead to transcient muscle blockade, wich also can delay recovery.
In order to limit the use of nerve blocks to painful patients, we designed this study where the nerve block is performed only in patients experiencing significant paint after surgery.
In conclusion, this study aims to assess the benefits of performing a rescue SIFIB in the recovery room for patients who experience significant postoperative pain after hip replacement surgery. The evaluation will focus on pain relief and ability to walk.
No new treatment is being tested. The technique uses a commonly administered local anesthetic to numb the nerves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, assessor and patient blinded, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| SIFIB group | Experimental | Procedure: Ultrasound guided supra inguinal fascia iliaca block, Procedure: Surgical and anesthetic protocolThe ultrasound probe is placed in a cephalo-caudal orientation, over the inguinal ligament, lateral to the femoral nerve. The iliacus muscle, which is covered caudally by the sartorius muscle and cephalically by the internal oblique muscle, is visualized in depth. Between these two muscles, an area is identified where the iliacus muscle is covered only by subcutaneous tissue. The needle is introduced in a cranio-caudal direction, and the injection is initiated in this area, beneath the fascia iliaca. The needle then advances through the space created by the injection, as far as possible in a cephalic direction, beneath the internal oblique muscle. An injection of 40 ml of 0.1% ropivacaine is administered. |
| Placebo group | Sham comparator | Procedure: Placebo Injection, Procedure: Surgical and anesthetic protocolFive milliliters of saline are injected subcutaneously under ultrasound guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient scheduled for a primary total hip arthroplasty under general anesthesia,
- written informed consent.
- contra indication to ropivacaine
- vulnerable person
Key exclusion criteria (2 listed)
- per-operative complication making wheight-bearing and walking contra-indicated.
- patient without significant pain post-operatively.
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 |
|---|---|---|
| Ultrasound guided supra inguinal fascia iliaca blockThe ultrasound probe is placed in a cephalo-caudal orientation, over the inguinal ligament, lateral to the femoral nerve. The iliacus muscle, which is covered caudally by the sartorius muscle and cephalically by the internal oblique muscle, is visualized in depth. Between these two muscles, an area is identified where the iliacus muscle is covered only by subcutaneous tissue. The needle is introduced in a cranio-caudal direction, and the injection is initiated in this area, beneath the fascia iliaca. The needle then advances through the space created by the injection, as far as possible in a cephalic direction, beneath the internal oblique muscle. An injection of 40 ml of 0.1% ropivacaine is administered. | Procedure or surgery | SIFIB group |
| Placebo InjectionFive milliliters of saline are injected subcutaneously under ultrasound guidance | Procedure or surgery | Placebo group |
| Surgical and anesthetic protocolAll patients receive standard general anesthesia: * Induction of anesthesia by sufentanil, ketamine, propofol and tracrium if needed, * Maintenance of anesthesia by sevoflurane and sufentanil if needed, * Prevention of PONV by dexamethasone and droperidol, * Post-operative analgesia by paracetamol, ketoprofene, nefopam, as indicated. Total hip arthroplasty is performed by anterior or postero-lateral approach, depending on surgeon preference. In the post-anesthesia care unit, if numerical pain rating scale at rest is >=4, patients are randomized to receive experimental or placebo intervention. | Procedure or surgery | Placebo group, SIFIB group |
Primary outcome
Composite outcome
Time frame: 2 hours post operatively
Composite outcome is validated if all of these 3 items are validated: * numerical pain rating scale (from 0 to 10) at rest is < 4, * and intravenous morphine < 0,1 mg/kg, * and first mobilization successful. First mobilization is validated if patient can stand up, walk 5 meters then sit down in a wheelchair.
4 secondary outcomes
Morphine consumption
Time frame: 24 hours post operatively
Pain evaluation
Time frame: 6, 12 and 24 hours post operatively
Length of hospital stay
Time frame: An average of 2 to 3 days up to 1 week
Patient satisfaction
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Background: PubMed 28059869Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.
- Background: PubMed 30683117Zhang XY, Ma JB. The efficacy of fascia iliaca compartment block for pain control after total hip arthroplasty: a meta-analysis. J Orthop Surg Res. 2019 Jan 25;14(1):33. doi: 10.1186/s13018-018-1053-1.
- Background: PubMed 36597677Changjun C, Xin Z, Yue L, Liyile C, Pengde K. Key Elements of Enhanced Recovery after Total Joint Arthroplasty: A Reanalysis of the Enhanced Recovery after Surgery Guidelines. Orthop Surg. 2023 Mar;15(3):671-678. doi: 10.1111/os.13623. Epub 2023 Jan 3.
- Background: PubMed 37295649Bloc S, Alfonsi P, Belbachir A, Beaussier M, Bouvet L, Campard S, Campion S, Cazenave L, Diemunsch P, Di Maria S, Dufour G, Fabri S, Fletcher D, Garnier M, Godier A, Grillo P, Huet O, Joosten A, Lasocki S, Le Guen M, Le Sache F, Macquer I, Marquis C, de Montblanc J, Maurice-Szamburski A, Nguyen YL, Ruscio L, Zieleskiewicz L, Caillard A, Weiss E. Guidelines on perioperative optimization protocol for the adult patient 2023. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101264. doi: 10.1016/j.accpm.2023.101264. Epub 2023 Jun 7.
- Background: PubMed 34015859Anger M, Valovska T, Beloeil H, Lirk P, Joshi GP, Van de Velde M, Raeder J; PROSPECT Working Group* and the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guideline for total hip arthroplasty: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Aug;76(8):1082-1097. doi: 10.1111/anae.15498. Epub 2021 May 20.
- Background: PubMed 34433647Memtsoudis SG, Cozowicz C, Bekeris J, Bekere D, Liu J, Soffin EM, Mariano ER, Johnson RL, Go G, Hargett MJ, Lee BH, Wendel P, Brouillette M, Kim SJ, Baaklini L, Wetmore DS, Hong G, Goto R, Jivanelli B, Athanassoglou V, Argyra E, Barrington MJ, Borgeat A, De Andres J, El-Boghdadly K, Elkassabany NM, Gautier P, Gerner P, Gonzalez Della Valle A, Goytizolo E, Guo Z, Hogg R, Kehlet H, Kessler P, Kopp S, Lavand'homme P, Macfarlane A, MacLean C, Mantilla C, McIsaac D, McLawhorn A, Neal JM, Parks M, Parvizi J, Peng P, Pichler L, Poeran J, Poultsides L, Schwenk ES, Sites BD, Stundner O, Sun EC, Viscusi E, Votta-Velis EG, Wu CL, YaDeau J, Sharrock NE. Peripheral nerve block anesthesia/analgesia for patients undergoing primary hip and knee arthroplasty: recommendations from the International Consensus on Anesthesia-Related Outcomes after Surgery (ICAROS) group based on a systematic review and meta-analysis of current literature. Reg Anesth Pain Med. 2021 Nov;46(11):971-985. doi: 10.1136/rapm-2021-102750. Epub 2021 Aug 25.
- Background: PubMed 23392233Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
- 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.
Abderrahmen BARGAOUI, MD principal investigator
Institut Mutualiste Montsouris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided supra inguinal fascia iliaca block and Surgical and anesthetic protocol in people with Hip Arthroplasty, Total and Post Operative Pain, Acute, run by Institut Mutualiste Montsouris 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 25 Sep 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 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chahrazad Bey Boumezrag (+33 156616983, chahrazad.beyboumezrag@imm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome (time frame: 2 hours post operatively). 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 NCT06982625, which also lists 7 linked publications.
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 25 Sep 2025.