Pain, PostoperativePhase 2/3KETALIDONCT02969733
The Interest of the Xylocaine® and Ketamine on the Management of Acute and Chronic Ain After Colectomy by Laparoscopy
A Phase 2/3 study testing Xylocaine, Ketamine and isotonic saline serum intravenous administration in people with Pain, Postoperative, run by University Hospital, Lille at 1 site in France.
Trial summary
Recent clinical studies in abdominal surgery have shown that the use of Xylocaine® parenterally intraoperative at plasma concentrations below the toxic threshold of 5 .mu.g / ml, had an analgesic effect and decreased postoperative morphine consumption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Xylocaine, Ketamine and isotonic saline serum intravenous administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Sep 2017
- Phase
- Phase 2/3
- 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
- Surgery: segmental or total colectomy performed by laparoscopy
- Anesthesia state 1 and 3
Who cannot join
- Patients classified Anesthesia state 4 or 5
- Allergy or intolerance to any of the products used in the protocol
- Creatinine clearance calculated by the Cockcroft formula below 50 ml / min
- Hepatocellular insufficiency
- Severe heart failure
- Peptic ulcer
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- Chronic inflammatory bowel disease (IBD)
- Previous history of epilepsy or seizures
- Surgery emergency, palliative surgery, revision surgery
- Chronic pain requiring regular intake of analgesics include opioids
- Patients treated with lidocaine patch
- Psychic Disorder
- Additive Conduct vis-à-vis alcohol or mind-altering substances
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Interest of the Xylocaine® and Ketamine on the Per and Postoperative Management of Acute and Chronic Postoperative Pain After Colectomy by Laparoscopy
Recent clinical studies in abdominal surgery have shown that the use of Xylocaine® parenterally intraoperative at plasma concentrations below the toxic threshold of 5 .mu.g / ml, had an analgesic effect and decreased postoperative morphine consumption.
This study aims to evaluate the activity of Xylocaine® and ketamine separately administered parenterally, in terms of postoperative morphine consumption and decrease incidences of postoperative chronic pain at 3 and 6 months after laparoscopic colectomy compared the placebo group.
The evaluation of the intensity of postoperative pain, hyperalgesia perished skin surface scarring) and pain perception threshold by Pain Matcher® confirm or not the predictive nature of these criteria in the occurrence of chronic pain.
- Conditions
- Pain, Postoperative
- Being tested
- Xylocaine, Ketamine, isotonic saline serum intravenous administration
- Keywords
- postoperative analgesia, PainMatcher
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XylocaineDrug
Xylocaine is administered at a dose of 1.5 mg / kg for induction and then relay by syringe pump at a dose of 1.33 mg / kg / hour will be administered throughout the duration of the intervention and for 24 hours after the end of thereof, to obtain deemed effective plasma concentrations of the order of 0.5 to 5 mcg / mL.
KetamineDrug
Ketamine will be administered at a dose of 0.5 mg / kg and then relay by syringe pump at a dose of 0.05 mg / kg / hour for the duration of surgery and 24 hours after the end thereof.
isotonic saline serum intravenous administrationDrug
| Study group | Role | What they receive |
|---|---|---|
| Xylocaine | Experimental | intravenous administration Receives: Drug: Xylocaine |
| Ketamine | Experimental | intravenous administration Receives: Drug: Ketamine |
| isotonic saline serum | Placebo comparator | isotonic saline serum intravenous administration Receives: Drug: isotonic saline serum intravenous administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Measured: During the first 24 postoperative hours.
Secondary outcomes (8)
Morphine consumption
Measured: All 6 hours during the 48 postoperative hours.
Numeric rating scale score
Measured: All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.
Electric nociception threshold measured by PainMatcher
Measured: All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.
Hyperalgesia of peri-scar (in cm²) with a von Frey filament (pressure of 10 grams
Measured: At 2 days after postoperative
Questionnaire Douleur de Saint-Antoine (QDSA) ,
evaluation with validated scores for chronic and neuropathic pains
Measured: at 3 months, at 6 months
Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),
evaluation with validated scores for chronic and neuropathic pains
Measured: at 3 months, at 6 months
Time physiological function recovery
Ability to drink, to eat, to urinate, to walk
Measured: During the first 24 postoperative hours
Duration of hospital stay
Measured: At 5 days after postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startJan 2011
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Lebuffe, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969733
- Sponsor's protocol ID
- 2009_05/0943
- Other IDs
- 2009-017682-33, 2009
- Acronym
- KETALIDO
- Status last verified
- Sep 2017
- First submitted
- 14 Nov 2016
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interest of the Xylocaine® and Ketamine on the Per and Postoperative Management of Acute and Chronic Postoperative Pain After Colectomy by Laparoscopy
- ClinicalTrials.gov ID
- NCT02969733
- Acronym / sponsor ID
- KETALIDO / 2009_05/0943
- Conditions
- Pain, Postoperative
- Keywords
- postoperative analgesia, PainMatcher
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 21 Nov 2016 (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.
Recent clinical studies in abdominal surgery have shown that the use of Xylocaine® parenterally intraoperative at plasma concentrations below the toxic threshold of 5 .mu.g / ml, had an analgesic effect and decreased postoperative morphine consumption.
This study aims to evaluate the activity of Xylocaine® and ketamine separately administered parenterally, in terms of postoperative morphine consumption and decrease incidences of postoperative chronic pain at 3 and 6 months after laparoscopic colectomy compared the placebo group.
The evaluation of the intensity of postoperative pain, hyperalgesia perished skin surface scarring) and pain perception threshold by Pain Matcher® confirm or not the predictive nature of these criteria in the occurrence of chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Xylocaine | Experimental | Drug: Xylocaineintravenous administration |
| Ketamine | Experimental | Drug: Ketamineintravenous administration |
| isotonic saline serum | Placebo comparator | Drug: isotonic saline serum intravenous administrationisotonic saline serum intravenous administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgery: segmental or total colectomy performed by laparoscopy
- Anesthesia state 1 and 3
Key exclusion criteria (14 listed)
- Patients classified Anesthesia state 4 or 5
- Allergy or intolerance to any of the products used in the protocol
- Creatinine clearance calculated by the Cockcroft formula below 50 ml / min
- Hepatocellular insufficiency
- Severe heart failure
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 |
|---|---|---|
| XylocaineXylocaine is administered at a dose of 1.5 mg / kg for induction and then relay by syringe pump at a dose of 1.33 mg / kg / hour will be administered throughout the duration of the intervention and for 24 hours after the end of thereof, to obtain deemed effective plasma concentrations of the order of 0.5 to 5 mcg / mL. | Drug | Xylocaine |
| KetamineKetamine will be administered at a dose of 0.5 mg / kg and then relay by syringe pump at a dose of 0.05 mg / kg / hour for the duration of surgery and 24 hours after the end thereof. | Drug | Ketamine |
| isotonic saline serum intravenous administration | Drug | isotonic saline serum |
Primary outcome
Morphine consumption
Time frame: During the first 24 postoperative hours.
8 secondary outcomes
Morphine consumption
Time frame: All 6 hours during the 48 postoperative hours.
Numeric rating scale score
Time frame: All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.
Electric nociception threshold measured by PainMatcher
Time frame: All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.
Hyperalgesia of peri-scar (in cm²) with a von Frey filament (pressure of 10 grams
Time frame: At 2 days after postoperative
Questionnaire Douleur de Saint-Antoine (QDSA) ,
Time frame: at 3 months, at 6 months
Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),
Time frame: at 3 months, at 6 months
Time physiological function recovery
Time frame: During the first 24 postoperative hours
Duration of hospital stay
Time frame: At 5 days after postoperative
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 12 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Gilles Lebuffe, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Xylocaine, Ketamine and isotonic saline serum intravenous administration in people with Pain, Postoperative, run by University Hospital, Lille 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 2 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: finished, as of the sponsor's last update on 12 Sep 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 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Morphine consumption (time frame: During the first 24 postoperative hours.). 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 12 Sep 2017.