Low-dose Spinal Morphine for Post-Thoracotomy Pain After Video-Assisted Thoracoscopic Surgery

NCT ID: NCT01917448

Last Updated: 2016-04-08

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-01-31

Brief Summary

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One-thirds of patients underwent video-assisted thorascopic surgery still have severe pain. Therefore we want to demonstrate weather 0.15 mg spinal morphine would reduce 24 hour postoperative requirement comparing to control group.

Detailed Description

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Conditions

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Video-assisted Thoracoscopic Surgery

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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Control

The skin will be injected with local anesthetic without spinal block

Group Type SHAM_COMPARATOR

control

Intervention Type OTHER

Patient receive only local infiltration without spinal analgesia

Spinal morphine

0.15 mg spinal morphine

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

spinal morphine 0.15 mg

Interventions

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Morphine

spinal morphine 0.15 mg

Intervention Type DRUG

control

Patient receive only local infiltration without spinal analgesia

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ASA (American Society of Anesthesiologist) physical status I to III,
* Undergoing elective video-assisted thoracoscopic surgery at Siriraj and Thammasart Hospitals
* capable of using a patient-controlled analgesia (PCA) machine
* understanding the numeric rating scale (NRS) score for pain assessment.

Exclusion Criteria

* history of allergy to the study drugs
* bleeding disorder
* infection of the back
* refusing spinal anesthesia
* history of cerebrovascular disease
* using postoperative ventilator support were excluded
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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Faculty of Medicine, Siriraj Hospital, mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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2556

Identifier Type: -

Identifier Source: org_study_id

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