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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Pain, Chronic Pain, Neuropathic Pain

Intervention / Treatment
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* Drug: Placebo
* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo<br>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<br>* Normal saline applied by bolus before operation started, followed by a continuous application of normal saline for 24 hours.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic Pain, Chronic Pain, Posterolateral thoracotomy