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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01236495
First Posted: November 8, 2010
Last Update Posted: March 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sirilak Suksompong, Mahidol University
  Purpose
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.

Condition Intervention Phase
Solitary Mass Lung Diseases Drug: spinal morphine 0.3 mg Drug: spinal morphine 0.2 mg Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 Milligram for Post Lobectomy (Lung) Analgesia

Resource links provided by NLM:


Further study details as provided by Sirilak Suksompong, Mahidol University:

Primary Outcome Measures:
  • pethidine requirement [ Time Frame: 48 hours ]
    Total pethidine requirement during 48 hours postoperative


Enrollment: 40
Study Start Date: November 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: spinal morphine 0.2 mg
spinal morphine 0.2 mg
Drug: spinal morphine 0.2 mg
spinal morphine 0.2 mg
Other Name: morphine
Active Comparator: spinal morphine 0.3 mg
spinal morphine 0.3 mg
Drug: spinal morphine 0.3 mg
spinal morphine 0.3 mg
Other Name: morphine

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236495


Locations
Thailand
Faculty of Medicine, Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Sirilak Suksompong, M.D. Deaprt ment of Anesthesiology ,Faculty of Medicine, Siriraj Hospital
  More Information

Responsible Party: Sirilak Suksompong, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01236495     History of Changes
Other Study ID Numbers: si578/2010
First Submitted: November 5, 2010
First Posted: November 8, 2010
Last Update Posted: March 13, 2012
Last Verified: March 2012

Keywords provided by Sirilak Suksompong, Mahidol University:
thoracotomy
postoperative pain
spinal morphine

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Morphine
Meperidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia