Video-assisted Thoracoscopic Surgery Clinical Trial
Official title:
Low-dose Spinal Morphine for Post-Thoracotomy Pain After Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Double-Blind Controlled Trial
Verified date | April 2016 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ethical Committee |
Study type | Interventional |
One-thirds of patients underwent video-assisted thorascopic surgery still have severe pain. Therefore we want to demonstrate weather 0.15 mg spinal morphine would reduce 24 hour postoperative requirement comparing to control group.
Status | Completed |
Enrollment | 36 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - ASA (American Society of Anesthesiologist) physical status I to III, - Undergoing elective video-assisted thoracoscopic surgery at Siriraj and Thammasart Hospitals - capable of using a patient-controlled analgesia (PCA) machine - understanding the numeric rating scale (NRS) score for pain assessment. Exclusion Criteria: - history of allergy to the study drugs - bleeding disorder - infection of the back - refusing spinal anesthesia - history of cerebrovascular disease - using postoperative ventilator support were excluded |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Medicine, Siriraj Hospital, mahidol University | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total post-operative morphine requirement. | 48 hours | Yes | |
Secondary | Pain after surgery | 48 hour | Yes |
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