Acute PainNCT03105765
Acute and Chronic Pain, Especially Neuropathic Pain, After Thoracotomy and Continuous Application of Ketamine.
A study testing Ketamine in people with Acute Pain and Chronic Pain, run by Dr. Horst Schmidt Klinik GmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain, Chronic Pain, Neuropathic Pain
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- posterolateral thoracotomy for lung parenchyma resection
- informed consent
- ASA (American Society of Anesthesiologists) Status I-III
Who cannot join
- 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)
Show all 10Show fewer
- history of neurological or behavioral illness
- history of alcohol abuse
- history of chemotherapy or radiation
- opioid medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute Pain, Chronic Pain, Neuropathic Pain
- Being tested
- Placebo, Ketamine
- Keywords
- Neuropathic Pain, Chronic Pain, Posterolateral thoracotomy
- Medical subject headings
- Acute Pain, Chronic Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Normal saline applied by bolus before operation started, followed by a continuous application of normal saline for 24 hours.
KetamineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Active comparator | 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. Receives: Drug: Ketamine |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perioperative opioid consumption
The patients consumption of opioids is recorded once a day for a period of 7 days after operation.
Measured: 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.
Measured: 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
Measured: 7 days after operation
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: three month after operation
recovery time
Time between stopping intravenous anaesthesia and first eye opening of the Patient in minutes
Measured: eye opening after stopping anesthesia in minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study startJan 2011
- Primary completionAug 2014
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105765
- Sponsor's protocol ID
- HSK007
- Status last verified
- Apr 2017
- First submitted
- 12 Aug 2016
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ghezel-Ahmadi V, Beck G, Bolukbas S, Ghezel-Ahmadi D. Perioperative ketamine to reduce and prevent acute and chronic post-thoracotomy pain: a randomized, double-blind, placebo-controlled clinical trial. J Thorac Dis. 2024 Dec 31;16(12):8461-8471. doi: 10.21037/jtd-24-648. Epub 2024 Dec 28.
PubMed 39831260
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prophylactic Administration of Ketamine on Acute and Chronic Pain After Thoracotomy for Lung Cancer, a Double Blind Randomised Trial.
- ClinicalTrials.gov ID
- NCT03105765
- Acronym / sponsor ID
- HSK007
- Conditions
- Acute Pain, Chronic Pain, Neuropathic Pain
- Keywords
- Neuropathic Pain, Chronic Pain, Posterolateral thoracotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Active comparator | Drug: KetamineThe 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. |
| Placebo | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- posterolateral thoracotomy for lung parenchyma resection
- informed consent
- ASA (American Society of Anesthesiologists) Status I-III
Key exclusion criteria (10 listed)
- history of chronic pain
- history of neuropathic pain
- pregnancy or breastfeeding
- participation in another trial
- hypersensitivity for ketamine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboNormal saline applied by bolus before operation started, followed by a continuous application of normal saline for 24 hours. | Drug | Placebo |
| KetamineApplication 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. | Drug | Ketamine |
Primary outcome
Change in perioperative opioid consumption
Time frame: seven days after operation
The patients consumption of opioids is recorded once a day for a period of 7 days after operation.
Change in acute pain
Time frame: 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.
acute neuropathic pain
Time frame: 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
4 secondary outcomes
Change in chronic Pain
Time frame: one and three month after operation
Chronic Neuropathic pain
Time frame: one month after operation
Chronic Neuropathic Pain
Time frame: three month after operation
recovery time
Time frame: eye opening after stopping anesthesia in minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Derived from this study: PubMed 39831260Ghezel-Ahmadi V, Beck G, Bolukbas S, Ghezel-Ahmadi D. Perioperative ketamine to reduce and prevent acute and chronic post-thoracotomy pain: a randomized, double-blind, placebo-controlled clinical trial. J Thorac Dis. 2024 Dec 31;16(12):8461-8471. doi: 10.21037/jtd-24-648. Epub 2024 Dec 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine in people with Acute Pain and Chronic Pain, run by Dr. Horst Schmidt Klinik GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perioperative opioid consumption (time frame: seven days after operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03105765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.