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CompletedNCT02570230Updated Sep 8, 2021

Ketamine Combination With Spinal Morphine for Post Thoracic Surgery Pain : A Randomized Control Study

A Phase 4 interventional study of NSS and Ketamine in Pain and Postoperative Period, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-09-08.

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

Phase
Phase 4
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pain
  • Postoperative Period

Keywords

  • Thoracotomy
  • Postoperative pain
  • Ketamine
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 to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

patient with history of

  • allergy to morphine or ketamine
  • contraindicate to ketamine
  • remain intubated in the postoperative period
05

Study design

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

Study arms

  • Placebo comparator
    Control

    NSS infusion

    Other: NSS

  • Experimental
    Ketamine

    Ketamine 0.2 mg/kg/hr intravenous infusion

    Drug: Ketamine

Interventions

  • OtherNSS

    NSS infusion

  • DrugKetamine

    Ketamine 0.2 mg/kg/hr intravenous infusion

06

What researchers measure

Primary outcomes

  1. Time to first trigger of morphine

    Time to first trigger of morphine

    Time frame: 24 hours

Secondary outcomes

  1. 24-hr morphine consumption

    24-hr morphine consumption

    Time frame: 24 hours

  2. NRS score at 6, 24 hours

    NRS score (0-10) was assessed at at 6, 24 hours postoperative

    Time frame: 24 hours

  3. Incidence of nausea and vomiting

    Incidence of nausea and vomiting

    Time frame: 24 hours

07

Study locations

1 site
  • Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University
    Bangkok, 10700, Thailand
08

References and documents

Individual participant data

Plan to share: No

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 Sep 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02570230
Lead sponsor
Mahidol University
Responsible party
Sirilak Suksompong (Associate Professor, Mahidol University) — Principal investigator
First posted
Oct 7, 2015
Start date
Oct 1, 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Sep 8, 2021

Study contacts

Sirilak Suksompong, MD
principal investigator · Mahidol University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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