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Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 mg for Post Lobectomy Analgesia (pain)

Primary Purpose

Solitary Mass, Lung Diseases

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
spinal morphine 0.3 mg
spinal morphine 0.2 mg
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solitary Mass focused on measuring thoracotomy, postoperative pain, spinal morphine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 year and < 70 year
  • Patient ASA physical status I-III.
  • Scheduled for thoracotomy with lobectomy.
  • Can operate a patient-controlled analgesia (PCA) device.

Exclusion Criteria:

  • Known hypersensitivity to morphine or pethidine
  • History of bleeding tendency.
  • Known case of infection at the back
  • Patient refuse for spinal anesthesia
  • History of cerebrovascular disease.
  • Scheduled for video-assisted thoracoscopic lobectomy.
  • Need mechanical ventilatory support during postoperative period

Sites / Locations

  • Faculty of Medicine, Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

spinal morphine 0.2 mg

spinal morphine 0.3 mg

Arm Description

spinal morphine 0.2 mg

spinal morphine 0.3 mg

Outcomes

Primary Outcome Measures

pethidine requirement
Total pethidine requirement during 48 hours postoperative

Secondary Outcome Measures

Full Information

First Posted
November 5, 2010
Last Updated
March 11, 2012
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01236495
Brief Title
Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 mg for Post Lobectomy Analgesia
Acronym
pain
Official Title
Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 Milligram for Post Lobectomy (Lung) Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

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
The purpose of the study is to evaluate the amount of total pethidine requirement during the 48 hour postoperative period after receiving spinal morphine 0.2 and 0.3 mg.
Detailed Description
Thoracotomy causes severe pain to the patients. Continuous thoracic epidural is a gold standard for postoperative pain. However, it needs skill. There are many alternatives such as spinal morphine, intercostal nerve block, cryoalangesia or interpleural block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solitary Mass, Lung Diseases
Keywords
thoracotomy, postoperative pain, spinal morphine

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
spinal morphine 0.2 mg
Arm Type
Experimental
Arm Description
spinal morphine 0.2 mg
Arm Title
spinal morphine 0.3 mg
Arm Type
Active Comparator
Arm Description
spinal morphine 0.3 mg
Intervention Type
Drug
Intervention Name(s)
spinal morphine 0.3 mg
Other Intervention Name(s)
morphine
Intervention Description
spinal morphine 0.3 mg
Intervention Type
Drug
Intervention Name(s)
spinal morphine 0.2 mg
Other Intervention Name(s)
morphine
Intervention Description
spinal morphine 0.2 mg
Primary Outcome Measure Information:
Title
pethidine requirement
Description
Total pethidine requirement during 48 hours postoperative
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 year and < 70 year Patient ASA physical status I-III. Scheduled for thoracotomy with lobectomy. Can operate a patient-controlled analgesia (PCA) device. Exclusion Criteria: Known hypersensitivity to morphine or pethidine History of bleeding tendency. Known case of infection at the back Patient refuse for spinal anesthesia History of cerebrovascular disease. Scheduled for video-assisted thoracoscopic lobectomy. Need mechanical ventilatory support during postoperative period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sirilak Suksompong, M.D.
Organizational Affiliation
Deaprt ment of Anesthesiology ,Faculty of Medicine, Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 mg for Post Lobectomy Analgesia

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