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CompletedNCT01917448Updated Apr 8, 2016

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

A Phase 4 interventional study of Morphine and control in Video-assisted Thoracoscopic Surgery, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-08.

Sponsored by Mahidol University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Video-assisted Thoracoscopic Surgery

Keywords

  • postoperative pain
  • spinal morphine
  • video-assisted thoracoscopic surgery
03

In context

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Sham comparator
    Control

    The skin will be injected with local anesthetic without spinal block

    Other: control

  • Active comparator
    Spinal morphine

    0.15 mg spinal morphine

    Drug: Morphine

Interventions

  • DrugMorphine

    spinal morphine 0.15 mg

  • Othercontrol

    Patient receive only local infiltration without spinal analgesia

06

What researchers measure

Primary outcomes

  1. Total post-operative morphine requirement.

    Time frame: 48 hours

Secondary outcomes

  1. Pain after surgery

    Time frame: 48 hour

07

Study locations

1 site
  • Faculty of Medicine, Siriraj Hospital, mahidol University
    Bangkok, 10700, Thailand
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01917448
Lead sponsor
Mahidol University
Responsible party
Sirilak Suksompong (Associate Professor, Mahidol University) — Principal investigator
First posted
Aug 6, 2013
Start date
Feb 2014
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Apr 8, 2016

Study contacts

Sirilak Suksompong, MD
principal investigator · Mahidol University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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