ThoracotomyNCT00726258
Association of Intravenous Ketamine With Thoracic Epidural Analgesia: Effects on Pain and Respiratory Function Following Thoracotomy.
A study testing ketamine in people with Thoracotomy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Thoracotomy for lung resection is deemed painful. Ketamine is now a renewed interest in preventing acute postoperative pain. A previous study performed in the service testing the association ketamine/morphine versus morphine PCA, postoperative, for patients who do not benefit from postoperative epidural thoracic… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Thoracotomy
- What is being tested?
- ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to Dec 2010
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject between 18 and 85 years
- subject of both sexes
- subject operated in the service of thoracic surgery of a lobectomy by thoracotomie lateral or postlaterale subject
- subject operated in settled surgery
Who cannot join
- Against indication in the epidural insanity,
- confusionnel, patient psychotic
- treatment in the long price by medicine which can interfere on the pain (morphine, antidepressants, psychotropic treatment)
Trial locations and contacts
1 site in 1 country.
France1 site
Service de chirurgie Orthopédique-Traumatologie - Hopital Sainte Marguerite
Marseille, 13009
About this study
Thoracotomy for lung resection is deemed painful. Ketamine is now a renewed interest in preventing acute postoperative pain. A previous study performed in the service testing the association ketamine/morphine versus morphine PCA, postoperative, for patients who do not benefit from postoperative epidural thoracic surgery, has demonstrated a reduction of postoperative pain associated with a reduction of nocturnal arterial desaturation following surgery when ketamine was added to morphine.
Read the detailed description
In this prospective double blind randomized study, intravenous administration of an analgesic dose of ketamine was started since the induction of general anesthesia and continued during the first 48 postoperative hours in association with epidural analgesia.
- Conditions
- Thoracotomy
- Being tested
- ketamine, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
ketamine with various concentrations
placeboDrug
physiological serum
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Drip of physiological serum Receives: Drug: placebo |
| 2 | Active comparator | Drip of ketamine Receives: Drug: ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the immediate postoperative analgesic effect of the association ketamine IV-thoracic epidural with regard to the use of the only epidural
Measured: 24 months
Secondary outcomes (2)
To estimate the effect of the association ketamine IV thoracic epidural on the postoperative pain postponed in 1, 3 and 6 months
Measured: 24 months
To estimate the effect of the association ketamine IV thoracic epidural on the incidence of the urinary side effects and hémodynamiques of the epidural
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2010
- Study completionDec 2010
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 ThoracotomyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Françoise GAILLAT, MD, Principal investigator, Assistance Publique des Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726258
- Sponsor's protocol ID
- 2007-00336-20
- Other IDs
- 2007-04
- Status last verified
- Aug 2014
- First submitted
- 30 Jul 2008
- Last updated
- 28 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Joseph C, Gaillat F, Duponq R, Lieven R, Baumstarck K, Thomas P, Penot-Ragon C, Kerbaul F. Is there any benefit to adding intravenous ketamine to patient-controlled epidural analgesia after thoracic surgery? A randomized double-blind study. Eur J Cardiothorac Surg. 2012 Oct;42(4):e58-65. doi: 10.1093/ejcts/ezs398. Epub 2012 Jul 12.
PubMed 22790008
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Intravenous Ketamine With Thoracic Epidural Analgesia: Effects on Pain and Respiratory Function Following Thoracotomy.
- ClinicalTrials.gov ID
- NCT00726258
- Acronym / sponsor ID
- 2007-00336-20
- Conditions
- Thoracotomy
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 31 Jul 2008 (estimated)
- 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.
Thoracotomy for lung resection is deemed painful. Ketamine is now a renewed interest in preventing acute postoperative pain. A previous study performed in the service testing the association ketamine/morphine versus morphine PCA, postoperative, for patients who do not benefit from postoperative epidural thoracic surgery, has demonstrated a reduction of postoperative pain associated with a reduction of nocturnal arterial desaturation following surgery when ketamine was added to morphine.
Detailed description
In this prospective double blind randomized study, intravenous administration of an analgesic dose of ketamine was started since the induction of general anesthesia and continued during the first 48 postoperative hours in association with epidural analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placeboDrip of physiological serum |
| 2 | Active comparator | Drug: ketamineDrip of ketamine |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject between 18 and 85 years
- subject of both sexes
- subject operated in the service of thoracic surgery of a lobectomy by thoracotomie lateral or postlaterale subject
- subject operated in settled surgery
Key exclusion criteria (3 listed)
- Against indication in the epidural insanity,
- confusionnel, patient psychotic
- treatment in the long price by medicine which can interfere on the pain (morphine, antidepressants, psychotropic treatment)
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 |
|---|---|---|
| ketamineketamine with various concentrations | Drug | 2 |
| placebophysiological serum | Drug | 1 |
Primary outcome
To estimate the immediate postoperative analgesic effect of the association ketamine IV-thoracic epidural with regard to the use of the only epidural
Time frame: 24 months
2 secondary outcomes
To estimate the effect of the association ketamine IV thoracic epidural on the postoperative pain postponed in 1, 3 and 6 months
Time frame: 24 months
To estimate the effect of the association ketamine IV thoracic epidural on the incidence of the urinary side effects and hémodynamiques of the epidural
Time frame: 24 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2014.
- Derived from this study: PubMed 22790008Joseph C, Gaillat F, Duponq R, Lieven R, Baumstarck K, Thomas P, Penot-Ragon C, Kerbaul F. Is there any benefit to adding intravenous ketamine to patient-controlled epidural analgesia after thoracic surgery? A randomized double-blind study. Eur J Cardiothorac Surg. 2012 Oct;42(4):e58-65. doi: 10.1093/ejcts/ezs398. Epub 2012 Jul 12.
Related trials for Thoracotomy
RecruitingPhase 2/3
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Pain, Postoperative
Not yet recruitingObservational study
Preoperative Nutritional Status and Postoperative Outcomes in Geriatric Lung Resection
Thoracotomy, Toracosurgery
RecruitingObservational study
Continuous Erector Spinae Block Versus Thoracic Epidural Analgesia for the Prevention of Chronic Pain Following Thoracotomy: a Retrospective Study
Thoracic Surgery
Not yet recruiting
The Clinical Impact of Serratus Anterior VS. Erector Spinae Plane Block on Pain Management of Tube Thoracostomy in Emergency Department Patients.
Thoracostomy Pain Management, Pain Management
Active, not recruiting
Postoperative Opioid Consumption of Serratus Posterior Superior Intercostal Plane Block Versus Thoracic Paravertebral Block
Opioid Consumption, Postoperative
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.
Françoise GAILLAT, MD principal investigator
Assistance Publique des Hôpitaux de Marseille
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 Thoracotomy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 28 Aug 2014. 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 France. 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 was stopped early. Results are not available in the source record.
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?
To estimate the immediate postoperative analgesic effect of the association ketamine IV-thoracic epidural with regard to the use of the only epidural (time frame: 24 months). 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 NCT00726258, 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 28 Aug 2014.