0.15 mg Spinal Morphine vs. no Treatment for Morphine Requirement After VATs.

NCT ID: NCT01979354

Last Updated: 2015-11-10

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

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-12-31

Brief Summary

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Postoperative pain after Video-assisted Thoracoscopic Surgery (VAT) is still debating. Therefore the investigators conduct a study comparing 0.15 mg spinal morphine and control group in term of analgesia.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Spinal morphine

0.15 mg spinal morphine

Group Type ACTIVE_COMPARATOR

Spinal morphine

Intervention Type DRUG

0.15 mg spinal morphine

Control

No spinal morphine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Spinal morphine

0.15 mg spinal morphine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18 year or over
* Patient ASA physical status I-III.
* Scheduled for video-assisted thoracoscopic lobectomy or blebectomy with pleurectomy or pleural abrasion
* Can operate a patient-controlled analgesia (PCA) device.

Exclusion Criteria

* Known hypersensitivity to morphine
* History of bleeding tendency.
* Known case of infection at the back
* Patient refuse for spinal anesthesia
* History of cerebrovascular disease.
* Need mechanical ventilatory support during postoperative period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Sirilak Suksompong

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sirilak Suksompong, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Mahidol University

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Facility Contacts

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Sirilak Suksompong, MD

Role: primary

6624113256

Other Identifiers

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552/2556(EC3)

Identifier Type: -

Identifier Source: org_study_id

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