Clinical trial NCT06982625: Supra Inguinal Fascia Iliaca Block as Rescue Analgesia Following Total Hip Arthroplasty
Official title: Supra Inguinal Fascia Iliaca Block as Rescue Analgesia Following Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Arthroplasty, Total
Post Operative Pain, Acute
Nerve Block
Keywords: Total hip arthroplasty
Regional anesthesia
Nerve blocks
Supra-inguinal fascia iliaca block
Enhanced recovery after surgery
Acute post-operative pain
Rescue analgesia
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, assessor and patient blinded, placebo controlled
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Composite outcome
timeFrame: 2 hours post operatively
Secondary outcomes:
measure: Morphine consumption
timeFrame: 24 hours post operatively
measure: Pain evaluation
timeFrame: 6, 12 and 24 hours post operatively
measure: Length of hospital stay
timeFrame: An average of 2 to 3 days up to 1 week
measure: Patient satisfaction
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Institut Mutualiste Montsouris
name: Abderrahmen BARGAOUI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.
citation: Zhang XY, Ma JB. The efficacy of fascia iliaca compartment block for pain control after total hip arthroplasty: a meta-analysis. J Orthop Surg Res. 2019 Jan 25;14(1):33. doi: 10.1186/s13018-018-1053-1.
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citation: Anger M, Valovska T, Beloeil H, Lirk P, Joshi GP, Van de Velde M, Raeder J; PROSPECT Working Group* and the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guideline for total hip arthroplasty: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Aug;76(8):1082-1097. doi: 10.1111/anae.15498. Epub 2021 May 20.
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