The Efficacy of Pain Control After Total Hip Replacement Between Ultrasound Guided Supra-inguinal Fascia Iliaca Block and Intrathecal Morphine

Not Applicable

• Conditions: Total Hip Replacement; Ultrasound Guided Supra-inguinal Fascia Iliaca Block; Intrathecal Morphine; Postoperative Pain
• Interventions: Drug: Intrathecal morphine; Drug: Ultrasound guided supra-inguinal fascia iliaca block

• Registration Number: NCT04104204
• Lead Sponsor: Mahidol University

Brief Summary

Total hip replacement is one of major orthopedic surgery which result in severe postoperative pain especially at first 24 hours. Ultrasound guided regional anesthesia has become a part of multimodal analgesia.Ultrasound guided supra-inguinal fascia iliaca block is a new technique which can consistently cover femoral and lateral femoral cutaneous nerve. And with large volume (40ml), it may cover obturator nerve. This technique already proved to be useful for acute pain control in hip fracture or postoperative control in dynamic hip screw or nail insertion operation. However, it has not been compared with intrathecal morphine for total hip replacement yet.

Detailed Description

By using combine ultrasound guided supra-inguinal fascia iliaca block with periarticular infiltration with mutimodal analgesic drugs will have longer duration time to first rescue analgesic drug compared with combine intrathecal morphine with periarticular infiltration with multimodal analgesic drugs.

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: 2019-09-24
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-26
• Study Start: 2019-12-03
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-27
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• elective surgery of primary total hip replacement, body weight ≥40kg and BMI ≤35 kg/m2, competence to consent

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Exclusion Criteria

• contraindication to regional anesthesia, allergy to study drugs, skin infection at supra-inguinal fascia iliaca injection point, neurological deficit affecting the lower extremities, inability to use patient-controlled analgesia, GFR <50 mL/min

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal morphine	Intrathecal morphine	Intrathecal morphine 0.1 mg, A sham subcutaneous injection of 0.5 ml normal saline at inguinal area
Ultrasound guided supra-inguinal fascia iliaca block	Ultrasound guided supra-inguinal fascia iliaca block	0.25% bupivacaine 40 ml

Primary Outcome Measures

Name	Time	Method
Time to first analgesic request (PCA fentanyl)	48 hours	Whether ultrasound guided supra-inguinal fascia iliaca block can increase pain free period of patients undergo total hip replacement under spinal block compare with intrathecal morphine or not

Secondary Outcome Measures

Name	Time	Method
Pain score	48 hours	Pain score at rest and on movement rating by numerical rating scale in 48-hr postoperative
Amount of rescue analgesic drugs	48 hours	Amount of PCA fentanyl

Trial Locations

Locations (1)

Siriraj hospital; 🇹🇭 Bangkok, Thailand