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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03105765
Enrollment
200
Registered
2017-04-10
Start date
2011-01-31
Completion date
2016-08-31
Last updated
2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Chronic Pain, Neuropathic Pain

Keywords

Neuropathic Pain, Chronic Pain, Posterolateral thoracotomy

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.

Interventions

DRUGPlacebo

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

DRUGKetamine

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.

Sponsors

Dr. Horst Schmidt Klinik GmbH
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in perioperative opioid consumptionseven days after operationThe patients consumption of opioids is recorded once a day for a period of 7 days after operation.
Change in acute pain7 days after OperationThe 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.
acute neuropathic pain7 days after operationThe 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

MeasureTime frameDescription
Change in chronic Painone and three month after operationThe 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.
recovery timeeye opening after stopping anesthesia in minutesTime between stopping intravenous anaesthesia and first eye opening of the Patient in minutes
Chronic Neuropathic painone month after operationThe incidence of neuropathic pain will be measured by using the LANSS Pain Scale (Leeds assessment of neuropathic symptoms and signs) one month after operation
Chronic Neuropathic Painthree month after operationThe incidence of neuropathic pain will be measured by using the LANSS Pain Scale (Leeds assessment of neuropathic symptoms and signs) three month after operation

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026