Thoracic SurgeryPhase 4NCT01320475
Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine
A Phase 4 study testing Sufentanil and Ketamine in people with Thoracic Surgery, run by Hopital Foch at 1 site in France.
Trial summary
Thoracic epidural analgesia is often proposed to thoracotomized patients. A local anesthetic and an opioid are generally associated to produce an epidural analgesia. However, opioid epidural administration is frequently associated with adverse effects as nausea, vomiting, urinary retention, ... Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Sufentanil and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Jul 2011
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 75 yrs
- class ASA I, II or III
- lung surgery
Who cannot join
- Contra-indication to the achievement of epidural analgesia
- Preoperative chronic pain,
- Contra-indication to ketamine
- Hypersensitivity to ketamine or any excipients
- Uncontrolled hypertension,
- Stroke
Show all 14Show fewer
- Heart failure
- Hepatic porphyria
- Contra-indication to sufentanil
- Hypersensitivity to sufentanil, opioids or any excipients
- Treatment with an opioid agonist-antagonist,
- Contra-indication to levobupivacaine
- Hypersensitivity to levobupivacaine, local anesthetics of the amide or any excipients
- Hypotension, shock
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thoracic Epidural Analgesia: Epidural Levobupivacaine and Sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine
Thoracic epidural analgesia is often proposed to thoracotomized patients. A local anesthetic and an opioid are generally associated to produce an epidural analgesia. However, opioid epidural administration is frequently associated with adverse effects as nausea, vomiting, urinary retention, ... On the other hand, iv ketamine has been demonstrated to be an effective analgesic.
The purpose of the study is to compare the epidural administration of levobupivacaine and sufentanil or the epidural administration of levobupivacaine associated with the iv administration of ketamine.
- Conditions
- Thoracic Surgery
- Being tested
- Sufentanil, Ketamine
- Keywords
- thoracic epidural analgesia, epidural opioid, ketamine, adverse effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
Epidural infusion of levobupivacaine (1,25 mg/ml) and sufentanil(1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of saline (placebo for ketamine)
KetamineDrug
Epidural infusion of levobupivacaine (1,25 mg/ml) and saline (1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of ketamine (2 µg/kg/minute) Up to the third postoperative day (6 PM)
| Study group | Role | What they receive |
|---|---|---|
| iv Ketamine | Experimental | Epidural infusion of levobupivacaine and saline (placebo for sufentanil)and iv infusion of ketamine Up to the third postoperative day (6 PM) Receives: Drug: Ketamine |
| Sufentanil | Active comparator | Epidural infusion of levobupivacaine (1,25 mg/ml) and sufentanil(1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of saline (placebo for ketamine) Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of an adverse event due to the analgesic protocol
Measured: one week
Efficacy of the analgesic regimen
Measured: third postoperative day
Secondary outcomes (5)
postoperative rehabilitation
Measured: two weeks
postoperative complications (pulmonary, others)
Measured: one month
length of stay
Measured: one month
patient's satisfaction
Measured: sortie de l'hopital
Occurence of a chronic pain
Measured: end the first postoperative year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startSep 2010
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Difficulty of Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320475
- Sponsor's protocol ID
- 2009/04
- Status last verified
- Sep 2016
- First submitted
- 19 Mar 2011
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Epidural Analgesia: Epidural Levobupivacaine and Sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine
- ClinicalTrials.gov ID
- NCT01320475
- Acronym / sponsor ID
- 2009/04
- Conditions
- Thoracic Surgery
- Keywords
- thoracic epidural analgesia, epidural opioid, ketamine, adverse effect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty of Recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 22 Mar 2011 (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.
Thoracic epidural analgesia is often proposed to thoracotomized patients. A local anesthetic and an opioid are generally associated to produce an epidural analgesia. However, opioid epidural administration is frequently associated with adverse effects as nausea, vomiting, urinary retention, ... On the other hand, iv ketamine has been demonstrated to be an effective analgesic.
The purpose of the study is to compare the epidural administration of levobupivacaine and sufentanil or the epidural administration of levobupivacaine associated with the iv administration of ketamine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iv Ketamine | Experimental | Drug: KetamineEpidural infusion of levobupivacaine and saline (placebo for sufentanil)and iv infusion of ketamine Up to the third postoperative day (6 PM) |
| Sufentanil | Active comparator | Drug: SufentanilEpidural infusion of levobupivacaine (1,25 mg/ml) and sufentanil(1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of saline (placebo for ketamine) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 18 and 75 yrs
- class ASA I, II or III
- lung surgery
Key exclusion criteria (14 listed)
- Contra-indication to the achievement of epidural analgesia
- Preoperative chronic pain,
- Contra-indication to ketamine
- Hypersensitivity to ketamine or any excipients
- Uncontrolled hypertension,
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 |
|---|---|---|
| SufentanilEpidural infusion of levobupivacaine (1,25 mg/ml) and sufentanil(1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of saline (placebo for ketamine) | Drug | Sufentanil |
| KetamineEpidural infusion of levobupivacaine (1,25 mg/ml) and saline (1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of ketamine (2 µg/kg/minute) Up to the third postoperative day (6 PM) | Drug | iv Ketamine |
Primary outcome
Occurrence of an adverse event due to the analgesic protocol
Time frame: one week
Efficacy of the analgesic regimen
Time frame: third postoperative day
5 secondary outcomes
postoperative rehabilitation
Time frame: two weeks
postoperative complications (pulmonary, others)
Time frame: one month
length of stay
Time frame: one month
patient's satisfaction
Time frame: sortie de l'hopital
Occurence of a chronic pain
Time frame: end the first postoperative year
Results and safety
The study was stopped early (reason given: Difficulty of Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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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 Phase 4 study testing Sufentanil and Ketamine in people with Thoracic Surgery, run by Hopital Foch 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 3 inclusion and 14 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 23 Sep 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty of Recruitment). 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?
Occurrence of an adverse event due to the analgesic protocol (time frame: one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2016.