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

ConditionsHip Arthroplasty, TotalPost Operative Pain, AcuteNerve Block
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Mutualiste Montsouris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patient scheduled for a primary total hip arthroplasty under general anesthesia,

written informed consent.

contra indication to ropivacaine

vulnerable person

Disqualifiers

per-operative complication making wheight-bearing and walking contra-indicated.

patient without significant pain post-operatively.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound guided supra inguinal fascia iliaca block

    Procedure/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 Injection

    Procedure/Surgery

    Five milliliters of saline are injected subcutaneously under ultrasound guidance

  • Surgical and anesthetic protocol

    Procedure/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.

Treatment groups

310 Participants
are divided into 2 treatment groups
Group A: SIFIB groupExperimental treatment 2 interventions
Group B: Placebo groupSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Morphine consumption

oral morphine equivalent needings

Time frame
24 hours post operatively
2

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
3

Length of hospital stay

Number of in-hospital post operative nights

Time frame
An average of 2 to 3 days up to 1 week
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Mutualiste Montsouris

Lead sponsor

Source ClinicalTrials.gov
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