NCT01979354

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Feb 2014

Longer than P75 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

2.8 years

First QC Date

November 2, 2013

Last Update Submit

November 9, 2015

Conditions

Postoperative Pain

Keywords

spinal morphineVATs lobectomy

Outcome Measures

Primary Outcomes (1)

  • Total morphine requirement in 48 hours

    48 hours

Secondary Outcomes (1)

  • Pain

    48 hours

Study Arms (2)

Spinal morphine

ACTIVE COMPARATOR

0.15 mg spinal morphine

Drug: Spinal morphine

Control

NO INTERVENTION

No spinal morphine

Interventions

Spinal morphineDRUG

0.15 mg spinal morphine

Spinal morphine

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahidol University

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

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

November 2, 2013

First Posted

November 8, 2013

Study Start

February 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

TH(1)