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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Spinal morphine
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring spinal morphine, VATs lobectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Spinal morphine

Control

Arm Description

0.15 mg spinal morphine

No spinal morphine

Outcomes

Primary Outcome Measures

Total morphine requirement in 48 hours

Secondary Outcome Measures

Pain

Full Information

First Posted
November 2, 2013
Last Updated
November 9, 2015
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01979354
Brief Title
0.15 mg Spinal Morphine vs. no Treatment for Morphine Requirement After VATs.
Official Title
The Comparison of 0.15 Milligram Spinal Morphine vs.no Treatment for Morphine Requirement After Video-assisted Thoracoscopic Surgery. A Pilot Randomized Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
spinal morphine, VATs lobectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal morphine
Arm Type
Active Comparator
Arm Description
0.15 mg spinal morphine
Arm Title
Control
Arm Type
No Intervention
Arm Description
No spinal morphine
Intervention Type
Drug
Intervention Name(s)
Spinal morphine
Intervention Description
0.15 mg spinal morphine
Primary Outcome Measure Information:
Title
Total morphine requirement in 48 hours
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Pain
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sirilak Suksompong, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sirilak Suksompong, MD
Phone
6624113256
Email
sirilak.suk@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Sirilak Suksompong, MD

12. IPD Sharing Statement

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

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