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Completed

NCT Number: NCT03105765

Acute and Chronic Pain, Especially Neuropathic Pain, After Thoracotomy and Continuous Application of Ketamine.

Chronic Pain, especially neuropathic pain, are adverse events after posterolateral thoracotomy for lung resection. The continuous application of ketamine may have a prophylactic effect and helps to prevent chronic pain. The investigators record the incidence and severity of acute pain and neuropathic pain during a seven day period after thoracotomy as well as the incidence of chronic pain and neuropathic pain after one and three month period. Parallel Group design, comparing one Group with a continuous application (24 hours) of ketamine against a Placebo Group.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Horst Schmidt Klinik

Wiesbaden, Hesse, 65199, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • posterolateral thoracotomy for lung parenchyma resection
  • informed consent
  • ASA (American Society of Anesthesiologists) Status I-III

Exclusion criteria

  • history of chronic pain
  • history of neuropathic pain
  • pregnancy or breastfeeding
  • participation in another trial
  • hypersensitivity for ketamine
  • medication with can influence neuropathic pain (gabapentin, clonazepam)
  • history of neurological or behavioral illness
  • history of alcohol abuse
  • history of chemotherapy or radiation
  • opioid medication

Treatment and study plan

Placebo

Drug

Normal saline applied by bolus before operation started, followed by a continuous application of normal saline for 24 hours.

ketamine

Drug

Application of Ketamine 0,2mg/kg ideal Body weight by Bolus before the Operation started, followed by application of 0,2 mg/kg ideal Body weight for 24 hours.

Primary outcomes

  1. Change in perioperative opioid consumption

    Time frame: seven days after operation

    The patients consumption of opioids is recorded once a day for a period of 7 days after operation.

  2. Change in acute pain

    Time frame: 7 days after Operation

    The incidence and severity of pain will be measured using a numeric analog scale (NAS) once a day for a period of seven days after Operation.

  3. acute neuropathic pain

    Time frame: 7 days after operation

    The incidence of neuropathic pain will be measured using the LANSS Pain Scale (Leeds assessment of neuropathic symptoms and signs) three and seven days after operation

Secondary outcomes

  1. Change in chronic Pain

    Time frame: one and three month after operation

    The incidence and severity of pain will be measured using a numeric analog scale (NAS). Pain scale is requested by phone one and three month after Operation.

  2. Chronic Neuropathic pain

    Time frame: one month after operation

    The incidence of neuropathic pain will be measured by using the LANSS Pain Scale (Leeds assessment of neuropathic symptoms and signs) one month after operation

  3. Chronic Neuropathic Pain

    Time frame: three month after operation

    The incidence of neuropathic pain will be measured by using the LANSS Pain Scale (Leeds assessment of neuropathic symptoms and signs) three month after operation

  4. recovery time

    Time frame: eye opening after stopping anesthesia in minutes

    Time between stopping intravenous anaesthesia and first eye opening of the Patient in minutes

Sponsors and collaborators

Lead sponsor

Dr. Horst Schmidt Klinik GmbH

Industry

Registry information

Official study title

Effects of Prophylactic Administration of Ketamine on Acute and Chronic Pain After Thoracotomy for Lung Cancer, a Double Blind Randomised Trial.

Important dates

Study start
2011
Primary completion
2014
Study completion
2016
First posted
Apr 10, 2017
Registry last updated
Apr 10, 2017

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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