An interventional study of Ultrasound guided supra inguinal fascia iliaca block and Placebo Injection in Hip Arthroplasty, Total, Post Operative Pain, Acute and Nerve Block, sponsored by Institut Mutualiste Montsouris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Institut Mutualiste Montsouris · Not applicable, Interventional, and Treatment
Among 102 studies in Pain, Postoperative with a site in France — 18 open to participants now, 21 under way, 3 of them phase 3. Pain, Postoperative · France.
Among the 102 studies in Pain, Postoperative with a site in France, this one is the 14th largest by planned enrollment of the 83 interventional ones, is one of 4 that started in 2025, is one of 41 with no phase, reaches primary completion later than 12 of the 20 other live ones, and was the 89th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 310 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →18 of the 102 studies in Pain, Postoperative with a site in France are open now, in 1 country. Each count lists the studies.
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →102 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 4 started in 2025.
Median enrollment 140 across the 83 interventional studies, 135 across the 19 observational. Of the 71 that completed or were terminated, 5 (7%) have results posted.
8 of 102 have an industry lead sponsor. The 10 most frequent:
Institut Mutualiste Montsouris is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
Institut Mutualiste Montsouris has 1 study filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
10 of the studies in Pain, Postoperative with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06381063Phase 3Centre Hospitalier Universitaire, AmiensNon-steroidal Anti-inflammatory in Cardiac Surgery | 2027-03 |
| NCT04576078Hospices Civils de LyonPost-operative Analgesic Effect of Oral Nefopam | 2026-12-30 |
| NCT06555107Centre Hospitalier Universitaire, AmiensAcute Preoperative Pain and Chronic Post-surgical Pain in Emergency Surgery | 2027-01 |
| NCT04219956Nantes University HospitalStudy to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery | 2027-04 |
| NCT07603271Institute Arnault Tzanck, FranceEarly Screening of Chronic Post-sternotomy Pain Using the DN4-i Questionnaire | 2027-05-03 |
Among the 102 studies in Pain, Postoperative with a site in France, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Non inclusion criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Ultrasound guided supra inguinal fascia iliaca block · Procedure: Surgical and anesthetic protocol
Five milliliters of saline are injected subcutaneously under ultrasound guidance
Procedure: Placebo Injection · Procedure: Surgical and anesthetic protocol
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.
Five milliliters of saline are injected subcutaneously under ultrasound guidance
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.
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.
Time frame: 2 hours post operatively
Morphine consumption
oral morphine equivalent needings
Time frame: 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.
Time frame: 6, 12 and 24 hours post operatively
Length of hospital stay
Number of in-hospital post operative nights
Time frame: 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)
Time frame: Day 1
Plan to share: No
Started Sep 2025 (actual). Primary completion is estimated for Sep 2027, 24 months after the start.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 24 months is above that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
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Institut Mutualiste Montsouris