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

NCT06982625 | Recruiting DMC

• 2 other identifiers: ANESTH-03-20242024-A02290-47
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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.

  2 hours post operatively

Secondary Outcomes (4)

• Morphine consumption

  24 hours post operatively

• Pain evaluation

  6, 12 and 24 hours post operatively

• Length of hospital stay

  An average of 2 to 3 days up to 1 week

• Patient satisfaction

  Day 1

Study Arms (2)

SIFIB group

EXPERIMENTAL

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.

Procedure: Ultrasound guided supra inguinal fascia iliaca block; Procedure: Surgical and anesthetic protocol

Placebo group

SHAM COMPARATOR

Five milliliters of saline are injected subcutaneously under ultrasound guidance

Procedure: Placebo Injection; Procedure: Surgical and anesthetic protocol

Interventions

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.

SIFIB group

Placebo Injection PROCEDURE

Five milliliters of saline are injected subcutaneously under ultrasound guidance

Placebo group

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.

Placebo group; SIFIB group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient scheduled for a primary total hip arthroplasty under general anesthesia,
• written informed consent.
• contra indication to ropivacaine
• vulnerable person

You may not qualify if:

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

Sponsors & Collaborators

• Institut Mutualiste Montsouris: lead

Study Sites (1)

Institut Mutualiste Montsouris

Paris, 75014, France

RECRUITING

Related Publications (7)

• 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.

  PMID: 28059869 BACKGROUND

• 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.

  PMID: 30683117 BACKGROUND

• Changjun C, Xin Z, Yue L, Liyile C, Pengde K. Key Elements of Enhanced Recovery after Total Joint Arthroplasty: A Reanalysis of the Enhanced Recovery after Surgery Guidelines. Orthop Surg. 2023 Mar;15(3):671-678. doi: 10.1111/os.13623. Epub 2023 Jan 3.

  PMID: 36597677 BACKGROUND

• Bloc S, Alfonsi P, Belbachir A, Beaussier M, Bouvet L, Campard S, Campion S, Cazenave L, Diemunsch P, Di Maria S, Dufour G, Fabri S, Fletcher D, Garnier M, Godier A, Grillo P, Huet O, Joosten A, Lasocki S, Le Guen M, Le Sache F, Macquer I, Marquis C, de Montblanc J, Maurice-Szamburski A, Nguyen YL, Ruscio L, Zieleskiewicz L, Caillard A, Weiss E. Guidelines on perioperative optimization protocol for the adult patient 2023. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101264. doi: 10.1016/j.accpm.2023.101264. Epub 2023 Jun 7.

  PMID: 37295649 BACKGROUND

• 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.

  PMID: 34015859 BACKGROUND

• Memtsoudis SG, Cozowicz C, Bekeris J, Bekere D, Liu J, Soffin EM, Mariano ER, Johnson RL, Go G, Hargett MJ, Lee BH, Wendel P, Brouillette M, Kim SJ, Baaklini L, Wetmore DS, Hong G, Goto R, Jivanelli B, Athanassoglou V, Argyra E, Barrington MJ, Borgeat A, De Andres J, El-Boghdadly K, Elkassabany NM, Gautier P, Gerner P, Gonzalez Della Valle A, Goytizolo E, Guo Z, Hogg R, Kehlet H, Kessler P, Kopp S, Lavand'homme P, Macfarlane A, MacLean C, Mantilla C, McIsaac D, McLawhorn A, Neal JM, Parks M, Parvizi J, Peng P, Pichler L, Poeran J, Poultsides L, Schwenk ES, Sites BD, Stundner O, Sun EC, Viscusi E, Votta-Velis EG, Wu CL, YaDeau J, Sharrock NE. Peripheral nerve block anesthesia/analgesia for patients undergoing primary hip and knee arthroplasty: recommendations from the International Consensus on Anesthesia-Related Outcomes after Surgery (ICAROS) group based on a systematic review and meta-analysis of current literature. Reg Anesth Pain Med. 2021 Nov;46(11):971-985. doi: 10.1136/rapm-2021-102750. Epub 2021 Aug 25.

  PMID: 34433647 BACKGROUND

• Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

  PMID: 23392233 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Abderrahmen BARGAOUI, MD

  Institut Mutualiste Montsouris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chahrazad Bey Boumezrag

CONTACT

+33 156616983; chahrazad.beyboumezrag@imm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, assessor and patient blinded, placebo controlled

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 21, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): September 22, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)