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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03280017
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Sirilak Suksompong, Mahidol University

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.


Condition or disease Intervention/treatment Phase
Pain, Acute Pain, Chronic Pain, Neuropathic Drug: Ketamine Drug: Normal saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Dose Intraoperative Intravenous Ketamine in Combination With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain: a Randomized Study
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
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
Drug: Ketamine
intravenous ketamine 0.2 mg/kg/hr (concentration 1 mg/ml)

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
Drug: Normal saline
normal saline infusion




Primary Outcome Measures :
  1. Postoperative morphine consumption [ Time Frame: 24 hours postoperatively ]
    Amount of morphine (in milligrams) which is dispensed from a patient-controlled analgesia device (PCA)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Chronic post-surgical pain [ Time Frame: 1 month ]
    The score of the Thai version of PainDetect questionnaire will be obtained at 1 month postoperatively

  5. Chronic post-surgical pain [ Time Frame: 3 months ]
    The score of the Thai version of PainDetect questionnaire will be obtained at 3 months postoperatively



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280017


Contacts
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Contact: Sirilak Suksompong, MD +66891534806 ssuksompong5@gmail.com
Contact: Panop Limratana, MD +66879479898 panop89@gmail.com

Locations
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Thailand
Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Sirilak Suksompoong, MD       ssuksompong5@gmail.com   
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Sirilak Suksompong Mahidol University
Publications:

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Responsible Party: Sirilak Suksompong, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT03280017    
Other Study ID Numbers: 297/2560(EC1)
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sirilak Suksompong, Mahidol University:
anesthesia
thoracic surgery
thoracic paravertebral block
ketamine
Additional relevant MeSH terms:
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Neuralgia
Acute Pain
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action