Clinical trial NCT04196439: Continuous Epidural Analgesia Versus Continuous Supra-Inguinal Fascia Iliaca Block in Total Hip Replacement Surgery
Official title: Comparison Of Continuous Epidural Analgesia And Ultrasound Guided Continuous Supra-Inguinal Fascia Iliaca Compartment Block After Total Hip Replacement Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: postoperative analgesia after THA surgery
timeFrame: 36 hours
Secondary outcomes:
measure: radiological pattern of local anaesthetic distribution in S-FICB group
timeFrame: 30 minutes after local anaesthetic injection
measure: success of rehabilitation
timeFrame: 36 hours
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria faculty of medicine
Study officials:
affiliation: Alexandria faculty of medicine
name: Emad A Abdelmonem, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.