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

April 6, 2016 updated by: Sirilak Suksompong, Mahidol University

Low-dose Spinal Morphine for Post-Thoracotomy Pain After Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Double-Blind Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of medicine, Siriraj hospital, Mahidol university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control
The skin will be injected with local anesthetic without spinal block
Other: control
Patient receive only local infiltration without spinal analgesia
Active Comparator: Spinal morphine
0.15 mg spinal morphine
Drug: Morphine
spinal morphine 0.15 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total post-operative morphine requirement.
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain after surgery
Time Frame: 48 hour
48 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

August 4, 2013

First Posted (Estimate)

August 6, 2013

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

April 6, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2556

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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