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

NCT ID: NCT04196439

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-02

Study Completion Date

2020-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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continuous epidural analgesia

continuous lumbar epidural catheter inserted preoperatively before induction of general anaesthesia

Group Type ACTIVE_COMPARATOR

continuous epidural analgesia

Intervention Type PROCEDURE

injection of local anaesthetic into epidural space

continuous supra-inguinal fascia iliaca compartment block

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

Group Type ACTIVE_COMPARATOR

supra-inguinal fascia iliaca compartment block

Intervention Type PROCEDURE

ultrasound guided injection of local anaesthetic into fascia iliaca compartment

Interventions

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continuous epidural analgesia

injection of local anaesthetic into epidural space

Intervention Type PROCEDURE

supra-inguinal fascia iliaca compartment block

ultrasound guided injection of local anaesthetic into fascia iliaca compartment

Intervention Type PROCEDURE

Other Intervention Names

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continuous epidural anaesthesia Supra-inguinal FICB

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Samir Alabd

assistant lecturer of anaesthesiology, Master degree

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emad A Abdelmonem, M.D.

Role: STUDY_CHAIR

Alexandria faculty of medicine

Locations

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Alexandria faculty of medicine

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ahmad S alabd, master

Role: CONTACT

Phone: 0020 1001643215

Email: [email protected]

Facility Contacts

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Emad A abdelmoem, M.D.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 30798268 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21401544 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30250982 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27943417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27684871 (View on PubMed)

Other Identifiers

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supra-inguinal fascia iliaca

Identifier Type: -

Identifier Source: org_study_id