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Intrathecal Morphine and Fentanyl for Knee Arthroplasty

NCT ID: NCT03365115

Last Updated: 2017-12-07

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

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-02-01

Brief Summary

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This study is planned to investigate the efficacy of combined infusion of intrathecal morphine and fentanyl in patients undergoing total knee arthroplasty.

Detailed Description

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Conditions

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Knee Arthroplasty

Keywords

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spinal anesthesia morphine fentanyl pain knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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intrathecal fentanyl

Group Type ACTIVE_COMPARATOR

Intrathecal fentanyl

Intervention Type DRUG

Intrathecal fentanyl 25 mcg will be injected.

intrathecal morphine

Group Type ACTIVE_COMPARATOR

Intrathecal morphine

Intervention Type DRUG

Intrathecal morphine 100 mcg will be injected.

intrathecal morphine and fentantyl

Group Type EXPERIMENTAL

Intrathecal morphine

Intervention Type DRUG

Intrathecal morphine 100 mcg will be injected.

Intrathecal fentanyl

Intervention Type DRUG

Intrathecal fentanyl 25 mcg will be injected.

Interventions

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Intrathecal morphine

Intrathecal morphine 100 mcg will be injected.

Intervention Type DRUG

Intrathecal fentanyl

Intrathecal fentanyl 25 mcg will be injected.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled total knee replacement under spinal anesthesia
* ASA I-III

Exclusion Criteria

* Coagulopathy
* Heart disease
* Liver disease
* Kidney disease
* Infection
* Psychological disorder
* Allergy to bupivacaine
* Allergy to morphine
* Allergy to fentanyl
* Inability to use patient-controlled analgesic device
* Opioids due to chronic pain
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hyun-Chang Kim

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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201712001

Identifier Type: -

Identifier Source: org_study_id