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

M

Mahidol University

Status and phase

Completed
Phase 4

Conditions

Lung Diseases
Solitary Mass

Treatments

Drug: spinal morphine 0.3 mg
Drug: spinal morphine 0.2 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT01236495
si578/2010

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups

spinal morphine 0.2 mg
Experimental group
Description:
spinal morphine 0.2 mg
Treatment:
Drug: spinal morphine 0.2 mg
spinal morphine 0.3 mg
Active Comparator group
Description:
spinal morphine 0.3 mg
Treatment:
Drug: spinal morphine 0.3 mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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