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

Not Applicable

Not yet recruiting

• Conditions: Hip Arthroplasty, Total; Post Operative Pain, Acute; Nerve Block

• Registration Number: NCT06982625
• Lead Sponsor: Institut Mutualiste Montsouris

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-29
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-18
• Last Update Submitted: 2025-05-18
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2025-07-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite outcome	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 Outcome Measures

Name	Time	Method
Pain evaluation	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.
Morphine consumption	24 hours post operatively	oral morphine equivalent needings
Length of hospital stay	An average of 2 to 3 days up to 1 week	Number of in-hospital post operative nights
Patient satisfaction	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)