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

Institut Mutualiste Montsouris

Status

Enrolling

Conditions

Hip Arthroplasty, Total

Nerve Block

Post Operative Pain, Acute

Treatments

Procedure: Ultrasound guided supra inguinal fascia iliaca block

Procedure: Surgical and anesthetic protocol

Procedure: Placebo Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT06982625

2024-A02290-47 (Other Identifier)

ANESTH-03-2024

Details and patient eligibility

About

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.

Enrollment

310 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

310 participants in 2 patient groups

SIFIB group

Experimental group

Description:

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.

Treatment:

Procedure: Surgical and anesthetic protocol

Procedure: Ultrasound guided supra inguinal fascia iliaca block

Placebo group

Sham Comparator group

Description:

Five milliliters of saline are injected subcutaneously under ultrasound guidance

Treatment:

Procedure: Placebo Injection

Procedure: Surgical and anesthetic protocol