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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01979354
Other study ID # 552/2556(EC3)
Secondary ID
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


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
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