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NCT Number: NCT06982625

Supra Inguinal Fascia Iliaca Block as Rescue Analgesia Following Total Hip Arthroplasty

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.

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Key information

Conditions

Hip Arthroplasty, Total Nerve Block Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain, Acute Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Mutualiste Montsouris

Paris, 75014, France

Location status: Recruiting

Location contact

Abderrahmen Bargaoui, Dr

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient scheduled for a primary total hip arthroplasty under general anesthesia,
  • written informed consent.

Non inclusion criteria:

  • contra indication to ropivacaine
  • vulnerable person

Exclusion criteria

  • per-operative complication making wheight-bearing and walking contra-indicated.
  • patient without significant pain post-operatively.

Treatment and study plan

Ultrasound guided supra inguinal fascia iliaca block

Procedure

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 injection

Procedure

Five milliliters of saline are injected subcutaneously under ultrasound guidance

Surgical and anesthetic protocol

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Morphine consumption

    Time frame: 24 hours post operatively

    oral morphine equivalent needings

  2. Pain evaluation

    Time frame: 6, 12 and 24 hours post operatively

    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.

  3. Length of hospital stay

    Time frame: An average of 2 to 3 days up to 1 week

    Number of in-hospital post operative nights

  4. Patient satisfaction

    Time frame: Day 1

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Chahrazad Bey Boumezrag

CONTACT

[email protected]

+33 156616983

Sponsors and collaborators

Lead sponsor

Institut Mutualiste Montsouris

Other

Registry information

Acronym: SOSBIFSI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 21, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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