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

NCT01236495 | Completed Phase 4

• 1 other identifier: si578/2010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Solitary Mass; Lung Diseases

Keywords

thoracotomy; postoperative pain; spinal morphine

Outcome Measures

Primary Outcomes (1)

• pethidine requirement

  Total pethidine requirement during 48 hours postoperative

  48 hours

Study Arms (2)

spinal morphine 0.2 mg

EXPERIMENTAL

spinal morphine 0.2 mg

Drug: spinal morphine 0.2 mg

spinal morphine 0.3 mg

ACTIVE COMPARATOR

spinal morphine 0.3 mg

Drug: spinal morphine 0.3 mg

Interventions

spinal morphine 0.3 mg DRUG

spinal morphine 0.3 mg

Also known as: morphine

spinal morphine 0.3 mg

spinal morphine 0.2 mg DRUG

spinal morphine 0.2 mg

Also known as: morphine

spinal morphine 0.2 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine, Siriraj Hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Lung Diseases; Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Sirilak Suksompong, M.D.

  Deaprt ment of Anesthesiology ,Faculty of Medicine, Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 8, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 13, 2012

Record last verified: 2012-03

Locations

TH (1)