Continuous Epidural Analgesia Versus Continuous Supra-Inguinal Fascia Iliaca Block in Total Hip Replacement Surgery

Overview

comparison of continuous epidural analgesia and ultrasound guided continuous supra-inguinal fascia iliaca compartment block after total hip replacement surgery

Full Title of Study: “Comparison Of Continuous Epidural Analgesia And Ultrasound Guided Continuous Supra-Inguinal Fascia Iliaca Compartment Block After Total Hip Replacement Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2020

Detailed Description

supra-inguinal FICB is a promising safe approach for lumbar plexus that may be useful for analgesia in hip surgeries.In this study the investigators are comparing continuous S-FICB with continuous epidural analgesia after total hip arthroplasty surgeries with the primary aim to assess efficacy of post-operative analgesia, and secondary aim to assess rehabilitation indices, side effects and radiological pattern of local anaesthetic distribution after S-FICB.

Interventions

  • Procedure: continuous epidural analgesia
    • injection of local anaesthetic into epidural space
  • Procedure: supra-inguinal fascia iliaca compartment block
    • ultrasound guided injection of local anaesthetic into fascia iliaca compartment

Arms, Groups and Cohorts

  • Active Comparator: continuous epidural analgesia
    • continuous lumbar epidural catheter inserted preoperatively before induction of general anaesthesia
  • Active Comparator: continuous supra-inguinal fascia iliaca compartment block
    • ultrasound guided supra-inguinal FICB with insertion of catheter for continuous infusion before induction of general anaesthesia.

Clinical Trial Outcome Measures

Primary Measures

  • postoperative analgesia after THA surgery
    • Time Frame: 36 hours
    • visual analogue scale (VAS) scores for pain assessment at rest and movements and morphine consumption

Secondary Measures

  • radiological pattern of local anaesthetic distribution in S-FICB group
    • Time Frame: 30 minutes after local anaesthetic injection
    • imaging of pelvis using x-rays c arm machine
  • success of rehabilitation
    • Time Frame: 36 hours
    • rehabilitation indices achievement after THA

Participating in This Clinical Trial

Inclusion Criteria

  • orthopaedic patients, American Society of Anesthesiologists (ASA) physical status I-III, scheduled to undergo unilateral total hip replacement surgery via lateral approach Exclusion Criteria:

  • 1- History of neurological/neuromuscular, psychiatric disease, dementia preventing proper comprehension. 2- Patients younger than 18 years or older than 80 years. 3- Patients with Body Mass Index (BMI) <18.5 or >30 kg/m2. 4- Coagulation disturbances (INR>1.4, platelet count<100 000). 5- History of opioid dependence (opioid use within the last 4 weeks). 6- History of allergies to study medications. 7- Other contraindications to neuraxial blockade (e.g., patient refusal, local/systemic sepsis, low fixed cardiac output). 8- Contraindications to continuous fascia iliaca compartment block (e.g., infection overlying the injection site or previous femoro-popliteal bypass surgery).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alexandria University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmad Samir Alabd, assistant lecturer of anaesthesiology, Master degree – Alexandria University
  • Overall Official(s)
    • Emad A Abdelmonem, M.D., Study Chair, Alexandria faculty of medicine
  • Overall Contact(s)
    • ahmad S alabd, master, 0020 1001643215, ahmadsam23@gmail.com

References

Vermeylen K, Desmet M, Leunen I, Soetens F, Neyrinck A, Carens D, Caerts B, Seynaeve P, Hadzic A, Van de Velde M. Supra-inguinal injection for fascia iliaca compartment block results in more consistent spread towards the lumbar plexus than an infra-inguinal injection: a volunteer study. Reg Anesth Pain Med. 2019 Feb 22:rapm-2018-100092. doi: 10.1136/rapm-2018-100092. Online ahead of print.

Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.

Vermeylen K, Soetens F, Leunen I, Hadzic A, Van Boxtael S, Pomes J, Prats-Galino A, Van de Velde M, Neyrinck A, Sala-Blanch X. The effect of the volume of supra-inguinal injected solution on the spread of the injectate under the fascia iliaca: a preliminary study. J Anesth. 2018 Dec;32(6):908-913. doi: 10.1007/s00540-018-2558-9. Epub 2018 Sep 24.

Bullock WM, Yalamuri SM, Gregory SH, Auyong DB, Grant SA. Ultrasound-Guided Suprainguinal Fascia Iliaca Technique Provides Benefit as an Analgesic Adjunct for Patients Undergoing Total Hip Arthroplasty. J Ultrasound Med. 2017 Feb;36(2):433-438. doi: 10.7863/ultra.16.03012. Epub 2016 Dec 10.

Bang S, Chung J, Jeong J, Bak H, Kim D. Efficacy of ultrasound-guided fascia iliaca compartment block after hip hemiarthroplasty: A prospective, randomized trial. Medicine (Baltimore). 2016 Sep;95(39):e5018. doi: 10.1097/MD.0000000000005018.

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