0.15 mg Spinal Morphine vs. no Treatment for Morphine Requirement After VATs.

Postoperative Pain Clinical Trial

Official title:

The Comparison of 0.15 Milligram Spinal Morphine vs.no Treatment for Morphine Requirement After Video-assisted Thoracoscopic Surgery. A Pilot Randomized Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01979354
• Other study ID #: 552/2556(EC3)
• Status: Recruiting
• Phase: Phase 4
• First received: November 2, 2013
• Last updated: November 9, 2015
• Start date: February 2014
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Postoperative pain after Video-assisted Thoracoscopic Surgery (VAT) is still debating. Therefore the investigators conduct a study comparing 0.15 mg spinal morphine and control group in term of analgesia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 year or over

• Patient ASA physical status I-III.

• Scheduled for video-assisted thoracoscopic lobectomy or blebectomy with pleurectomy or pleural abrasion

• Can operate a patient-controlled analgesia (PCA) device.

Exclusion Criteria:

• Known hypersensitivity to morphine

• History of bleeding tendency.

• Known case of infection at the back

• Patient refuse for spinal anesthesia

• History of cerebrovascular disease.

• Need mechanical ventilatory support during postoperative period

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Spinal morphine
0.15 mg spinal morphine

Locations

Country	Name	City	State
Thailand	Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine requirement in 48 hours		48 hours	Yes
Secondary	Pain		48 hours	Yes