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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03105765
• Other study ID #: HSK007
• Status: Completed
• Phase: N/A
• First received: August 12, 2016
• Last updated: April 3, 2017
• Start date: January 2011
• Est. completion date: August 2016

Study information

• Verified date: April 2017
• Source: Dr. Horst Schmidt Klinik GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2016
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Neuralgia
• Neuropathic Pain

Intervention

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

Locations

Country	Name	City	State
Germany	Dr. Horst Schmidt Klinik	Wiesbaden	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Horst Schmidt Klinik GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	recovery time	Time between stopping intravenous anaesthesia and first eye opening of the Patient in minutes	eye opening after stopping anesthesia in minutes