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

NCT04196439 | Unknown

• 1 other identifier: supra-inguinal fascia iliaca
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• postoperative analgesia after THA surgery

  visual analogue scale (VAS) scores for pain assessment at rest and movements and morphine consumption

  36 hours

Secondary Outcomes (2)

• radiological pattern of local anaesthetic distribution in S-FICB group

  30 minutes after local anaesthetic injection

• success of rehabilitation

  36 hours

Study Arms (2)

continuous epidural analgesia

ACTIVE COMPARATOR

continuous lumbar epidural catheter inserted preoperatively before induction of general anaesthesia

Procedure: continuous epidural analgesia

continuous supra-inguinal fascia iliaca compartment block

ACTIVE COMPARATOR

ultrasound guided supra-inguinal FICB with insertion of catheter for continuous infusion before induction of general anaesthesia.

Procedure: supra-inguinal fascia iliaca compartment block

Interventions

continuous epidural analgesia PROCEDURE

injection of local anaesthetic into epidural space

Also known as: continuous epidural anaesthesia

continuous epidural analgesia

supra-inguinal fascia iliaca compartment block PROCEDURE

ultrasound guided injection of local anaesthetic into fascia iliaca compartment

Also known as: Supra-inguinal FICB

continuous supra-inguinal fascia iliaca compartment block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of neurological/neuromuscular, psychiatric disease, dementia preventing proper comprehension.
• 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).
• Contraindications to continuous fascia iliaca compartment block (e.g., infection overlying the injection site or previous femoro-popliteal bypass surgery).

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria faculty of medicine

Alexandria, 21131, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 30798268 BACKGROUND

• 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.

  PMID: 21401544 BACKGROUND

• 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.

  PMID: 30250982 BACKGROUND

• 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.

  PMID: 27943417 BACKGROUND

• 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.

  PMID: 27684871 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Emad A Abdelmonem, M.D.

  Alexandria faculty of medicine

  STUDY CHAIR

Central Study Contacts

ahmad S alabd, master

CONTACT

0020 1001643215; ahmadsam23@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of anaesthesiology, Master degree

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: December 12, 2019
• Study Start: November 2, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: December 12, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)