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NCT01917448 Clinical Trial

Low-dose Spinal Morphine for Post-Thoracotomy Pain After Video-Assisted Thoracoscopic Surgery

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01917448
Other study ID # 2556
Secondary ID
Status Completed
Phase Phase 4
First received August 2, 2013
Last updated April 6, 2016
Start date February 2014
Est. completion date January 2016

Study information
Verified date April 2016
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
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

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

  • Video-assisted Thoracoscopic Surgery

Intervention

Drug:
• Morphine
spinal morphine 0.15 mg
Other:
• control
Patient receive only local infiltration without spinal analgesia

Locations
Country Name City State
Thailand Faculty of Medicine, Siriraj Hospital, 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 post-operative morphine requirement. 48 hours Yes
Secondary Pain after surgery 48 hour Yes
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