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

NCT ID: NCT04104204

Last Updated: 2020-02-27

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

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-03

Study Completion Date

2021-12-31

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intrathecal morphine

Intrathecal morphine 0.1 mg, A sham subcutaneous injection of 0.5 ml normal saline at inguinal area

Group Type SHAM_COMPARATOR

Intrathecal morphine

Intervention Type DRUG

0.5% Iso/Hyperbaric bupivacaine 2-3 ml add morphine 0.1 mg for spinal anesthesia

Ultrasound guided supra-inguinal fascia iliaca block

0.25% bupivacaine 40 ml

Group Type EXPERIMENTAL

Ultrasound guided supra-inguinal fascia iliaca block

Intervention Type DRUG

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

Interventions

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Intrathecal morphine

0.5% Iso/Hyperbaric bupivacaine 2-3 ml add morphine 0.1 mg for spinal anesthesia

Intervention Type DRUG

Ultrasound guided supra-inguinal fascia iliaca block

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pawinee Pangthipampai, M.D.

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Siriraj hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Pawinee Pangthipampai, M.D.

Role: CONTACT

+6686 400 1721

Facility Contacts

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Pawinee Pangthipampai, M.D.

Role: primary

66864001721

Other Identifiers

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Si 404/2019

Identifier Type: -

Identifier Source: org_study_id

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