NCT01917448

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

1.9 years

First QC Date

August 2, 2013

Last Update Submit

April 6, 2016

Conditions

Video-assisted Thoracoscopic Surgery

Keywords

postoperative painspinal morphinevideo-assisted thoracoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Total post-operative morphine requirement.

    48 hours

Secondary Outcomes (1)

  • Pain after surgery

    48 hour

Study Arms (2)

Control

SHAM COMPARATOR

The skin will be injected with local anesthetic without spinal block

Other: control

Spinal morphine

ACTIVE COMPARATOR

0.15 mg spinal morphine

Drug: Morphine

Interventions

MorphineDRUG

spinal morphine 0.15 mg

Spinal morphine
controlOTHER

Patient receive only local infiltration without spinal analgesia

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Siriraj Hospital, mahidol University

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Sirilak Suksompong, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 6, 2013

Study Start

February 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 8, 2016

Record last verified: 2016-04

Locations

TH(1)