NCT02570230

Brief Summary

Thoracotomy is one of the most painful operation. Continuous thoracic epidural or paravertebral analgesia are gold standard for postoperative pain. But both techniques require skills. Spinal morphine is alternative simple method with less efficacy. Adding low dose ketamine during intraoperative may be helpful in postoperative pain relief.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Oct 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
2 years until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

October 5, 2015

Last Update Submit

August 31, 2021

Conditions

PainPostoperative Period

Keywords

ThoracotomyPostoperative painKetamine

Outcome Measures

Primary Outcomes (1)

  • Time to first trigger of morphine

    Time to first trigger of morphine

    24 hours

Secondary Outcomes (3)

  • 24-hr morphine consumption

    24 hours

  • NRS score at 6, 24 hours

    24 hours

  • Incidence of nausea and vomiting

    24 hours

Study Arms (2)

Control

PLACEBO COMPARATOR

NSS infusion

Other: NSS

Ketamine

EXPERIMENTAL

Ketamine 0.2 mg/kg/hr intravenous infusion

Drug: Ketamine

Interventions

NSSOTHER

NSS infusion

Control
KetamineDRUG

Ketamine 0.2 mg/kg/hr intravenous infusion

Ketamine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status 1-3
  • elective thoracotomy
  • can operate patient-controlled analgesia (PCA) machine

You may not qualify if:

  • patient with history of
  • allergy to morphine or ketamine
  • contraindicate to ketamine
  • remain intubated in the postoperative period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

PainPain, Postoperative

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

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

October 5, 2015

First Posted

October 7, 2015

Study Start

October 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

September 8, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)