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

Not Applicable

Completed

• Conditions: Neuropathic Pain; Acute Pain; Chronic Pain
• Interventions: Drug: Placebo; Drug: Ketamine

• Registration Number: NCT03105765
• Lead Sponsor: Dr. Horst Schmidt Klinik GmbH

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2014-08
• Study Completion: 2016-08
• Study First Submitted: 2016-08-12
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-03
• Last Update Submitted: 2017-04-03
• Study First Posted: 2017-04-10
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Ketamine	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.

Primary Outcome Measures

Name	Time	Method
Change in acute pain	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.
Change in perioperative opioid consumption	seven days after operation	The patients consumption of opioids is recorded once a day for a period of 7 days after operation.
acute neuropathic pain	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 Outcome Measures

Name	Time	Method
Chronic Neuropathic pain	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
recovery time	eye opening after stopping anesthesia in minutes	Time between stopping intravenous anaesthesia and first eye opening of the Patient in minutes
Change in chronic Pain	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.
Chronic Neuropathic Pain	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

Trial Locations

Locations (1)

Dr. Horst Schmidt Klinik; 🇩🇪 Wiesbaden, Hessen, Germany