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Completed

NCT Number: NCT03280017

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

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.

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Key information

Conditions

Pain, Acute Acute Pain Chronic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pain, Chronic Pain, Neuropathic Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Siriraj Hospital

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

intravenous ketamine 0.2 mg/kg/hr (concentration 1 mg/ml)

normal saline

Drug

normal saline infusion

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Low Dose Intraoperative Intravenous Ketamine in Combination With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain: a Randomized Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2017
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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