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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Acute Pain; Neuropathic Pain
• Intervention / Treatment: Drug: Ketamine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Wiesbaden, Hessen, Germany, 65199
      • Dr. Horst Schmidt Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ketamine; The patients in this Group underwent General anaesthesia with total intravenous anaesthesia containing remifentanil (0,02-0,04 mg/kg ideal Body weight), propofol (4-6 mg/kg ideal Body weight) and atracurium. Ketamine 0,2 mg/kg ideal Body weight per hour for 24 hours.	Drug: Ketamine; 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.
PLACEBO_COMPARATOR: Placebo; The patients in this Group underwent General anaesthesia with total intravenous anaesthesia containing remifentanil (0,02-0,04 mg/kg ideal Body weight), propofol (4-6 mg/kg ideal Body weight) and atracurium. Placebo (normal Saline) for 24 hours.	Drug: Placebo; Normal saline applied by bolus before operation started, followed by a continuous application of normal saline for 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perioperative opioid consumption	The patients consumption of opioids is recorded once a day for a period of 7 days after operation.	seven days after operation
Change in acute pain	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.	7 days after Operation
acute neuropathic pain	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	7 days after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in chronic Pain	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.	one and three month after operation
Chronic Neuropathic pain	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	one month after operation
Chronic Neuropathic Pain	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	three month after operation
recovery time	Time between stopping intravenous anaesthesia and first eye opening of the Patient in minutes	eye opening after stopping anesthesia in minutes

Collaborators and Investigators

• Sponsor: Dr. Horst Schmidt Klinik GmbH

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: August 12, 2016
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (ACTUAL): April 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Chronic Pain; Neuropathic Pain; Posterolateral thoracotomy
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Chronic Pain; Neuralgia; Acute Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: HSK007