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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:
Information provided by (Responsible Party):
Sirilak Suksompong, Mahidol University
ClinicalTrials.gov Identifier:
NCT01236495
First received: November 5, 2010
Last updated: March 11, 2012
Last verified: March 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • pethidine requirement [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sirilak Suksompong, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01236495     History of Changes
Other Study ID Numbers: si578/2010
Study First Received: November 5, 2010
Last Updated: March 11, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
thoracotomy
postoperative pain
spinal morphine

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

ClinicalTrials.gov processed this record on May 21, 2013