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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy of Pain Control After Total Hip Replacement Between Ultrasound Guide Supra-inguinal Fascia Iliaca Block and Intrathecal Morphine: A Randomized Controlled Trial

Conditions
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Total Hip Replacement, Ultrasound Guided Supra-inguinal Fascia Iliaca Block, Intrathecal Morphine, Postoperative Pain

Intervention / Treatment
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* Drug: Intrathecal morphine
* Drug: Ultrasound guided supra-inguinal fascia iliaca block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective surgery of primary total hip replacement, body weight ≥40kg and BMI ≤35 kg/m2, competence to consent 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Intrathecal morphine<br>Intrathecal morphine 0.1 mg, A sham subcutaneous injection of 0.5 ml normal saline at inguinal area | Drug: Intrathecal morphine<br>* 0.5% Iso/Hyperbaric bupivacaine 2-3 ml add morphine 0.1 mg for spinal anesthesia<br>|
| Experimental: Ultrasound guided supra-inguinal fascia iliaca block<br>0.25% bupivacaine 40 ml | Drug: Ultrasound guided supra-inguinal fascia iliaca block<br>* Ultrasound guided supra-inguinal fascia iliaca block with 0.25% bupivacaine 40 ml and 0.5% Iso/Hyperbaric bupivacaine 2-3 ml without spinal morphine for spinal anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first analgesic request (PCA fentanyl) | 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 | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain score at rest and on movement rating by numerical rating scale in 48-hr postoperative | 48 hours | 
| Amount of rescue analgesic drugs | Amount of PCA fentanyl | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total hip replacement, Ultrasound guided supra-inguinal fascia iliaca block, Intrathecal morphine, postoperative pain