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

Not Applicable

• Conditions: Postoperative Pain
• Interventions: Procedure: supra-inguinal fascia iliaca compartment block; Procedure: continuous epidural analgesia

• Registration Number: NCT04196439
• Lead Sponsor: Alexandria University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-01
• Study Start: 2019-11-02
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-10
• Last Update Submitted: 2019-12-10
• Study First Posted: 2019-12-12
• Last Update Posted: 2019-12-12
• Primary Completion: 2020-02
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
continuous supra-inguinal fascia iliaca compartment block	supra-inguinal fascia iliaca compartment block	ultrasound guided supra-inguinal FICB with insertion of catheter for continuous infusion before induction of general anaesthesia.
continuous epidural analgesia	continuous epidural analgesia	continuous lumbar epidural catheter inserted preoperatively before induction of general anaesthesia

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Alexandria faculty of medicine; 🇪🇬 Alexandria, Egypt