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Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain

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ClinicalTrials.gov Identifier: NCT03280017
Recruitment Status : Unknown
Verified October 2018 by Sirilak Suksompong, Mahidol University.
Recruitment status was:  Recruiting
First Posted : September 12, 2017
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Sirilak Suksompong, Mahidol University

Tracking Information
First Submitted Date  ICMJE September 10, 2017
First Posted Date  ICMJE September 12, 2017
Last Update Posted Date October 5, 2018
Actual Study Start Date  ICMJE September 25, 2017
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2017)
Postoperative morphine consumption [ Time Frame: 24 hours postoperatively ]
Amount of morphine (in milligrams) which is dispensed from a patient-controlled analgesia device (PCA)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2017)
  • Time to first analgesia [ Time Frame: 24 hours postoperatively ]
    Time period (in minutes) after the end of surgery until the time of first morphine solution is dispensed from PCA device
  • Peak flow rates (day 1) [ Time Frame: 1 days ]
    The value of peak flow velocity obtained from the first postoperative day will be compare with the value at the preoperative period
  • Peak flow rates (day 2) [ Time Frame: 2 days ]
    The value of peak flow velocity obtained from the first postoperative day will be compare with the value at the preoperative period
  • Chronic post-surgical pain [ Time Frame: 1 month ]
    The score of the Thai version of PainDetect questionnaire will be obtained at 1 month postoperatively
  • Chronic post-surgical pain [ Time Frame: 3 months ]
    The score of the Thai version of PainDetect questionnaire will be obtained at 3 months postoperatively
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain
Official Title  ICMJE Low Dose Intraoperative Intravenous Ketamine in Combination With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain: a Randomized Study
Brief Summary

Postoperative pain after thoracic surgery is associated with adverse outcomes. The current strategy to prevent postoperative pain is the use of regional anesthesia and analgesic agents. In video-assisted thoracic surgery (VATS), thoracic paravertebral block has become the standard analgesic regimen which results in decreased postoperative pain and opioid consumption.

The investigator would like to study the analgesic efficacy of low dose intravenous ketamine infusion during surgery in combination with thoracic paravertebral block on postoperative pain after VATS in a randomized study.

Detailed Description

Inadequate pain control after thoracic surgery is associated with adverse events such as postoperative pulmonary complications (PPC), and chronic post surgical pain.

Although the less invasive video-assisted thoracic surgery (VATS) has been used extensively as it produces optimal surgical outcomes and possible less postoperative pain, there are reports of inadequate pain control.

Thoracic paravertebral block (TPVB) has been introduced as an effective method in postoperative pain management after VATS. It is associated with improved pain control and the reduction of opioid analgesic consumption in several studies.

The use of intravenous low dose ketamine infusion during and after surgery has been shown to produce superior postoperative pain control in upper abdominal surgery and thoracotomy.

The aim of the present study is to study the efficacy of intravenous low dose ketamine infusion during surgery on acute and chronic pain after VATS.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain, Acute
  • Pain, Chronic
  • Pain, Neuropathic
Intervention  ICMJE
  • Drug: Ketamine
    intravenous ketamine 0.2 mg/kg/hr (concentration 1 mg/ml)
  • Drug: Normal saline
    normal saline infusion
Study Arms  ICMJE
  • Experimental: Ketamine
    Participant allocated to this arm will receive intravenous ketamine infusion starting after the induction of anesthesia until the end of the surgery at the beginning of skin closure Participant will receive an ultrasound-guide thoracic paravertebral block using 0.5% plain bupivacaine prior to the induction of anesthesia
    Intervention: Drug: Ketamine
  • Placebo Comparator: Normal saline
    Participant allocated to this arm will receive intravenous normal saline solution infusion starting after the induction of anesthesia until the end of the surgery at the beginning of skin closure Participant will receive an ultrasound-guide thoracic paravertebral block using 0.5% plain bupivacaine prior to the induction of anesthesia
    Intervention: Drug: Normal saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 10, 2017)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • American Society of Anesthesiologist physical status 1-3
  • Scheduled for elective video-assisted thoracic surgery
  • Able to operate a patient-controlled analgesia device (PCA)

Exclusion Criteria:

  • History of morphine allergy
  • History of bupivacaine allergy
  • Contraindication for ketamine infusion
  • Contraindication for thoracic paravertebral block
  • Anticipated postoperative positive pressure ventilation
  • Body mass index more than 35
  • Any known psychiatric disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03280017
Other Study ID Numbers  ICMJE 297/2560(EC1)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sirilak Suksompong, Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sirilak Suksompong Mahidol University
PRS Account Mahidol University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP