Pain, PostoperativePhase 3CATCHNCT01077752
Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia
A Phase 3 study testing continuous ropivacaine preperitoneal infusion, intravenous lidocaine infusion and parenteral analgesia combining acetaminophen and morphine in people with Pain, Postoperative, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In this multicenter, randomised, placebo-controlled, double-blind trial, hyperalgesia area around the scarce following colorectal laparoscopic surgery (piece removal) will be assessed in 3 groups of patients : group 1: continuous ropivacaine preperitoneal infusion, group 2 : intravenous lidocaine infusion, or group 3… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- continuous ropivacaine preperitoneal infusion, intravenous lidocaine infusion and parenteral analgesia combining acetaminophen and morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Feb 2013
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80
- ASA status 1 - 3
- Colorectal laparoscopic surgery with piece removal
- French speaking
- Written informed consent
Who cannot join
- laparoscopy without colorectal extraction
- chronic pain
- analgesic consumption during the 24 hours previous to the surgery
- morphine and LA intolerance
- drug addiction
- inflammatory bowel disease
Show all 13Show fewer
- general inflammatory disease
- sepsis
- anemia < 10 gr/dl
- liver or renal or cardiac insufficiency
- uncontrolled diabetes
- preoperative consumption of opiate/corticosteroid/beta-blockers, and anti-arrhythmic drugs, MAOIs, neuroleptics.
- preoperative consumption of NSAIDs excluding aspirin referred cardiology
Trial locations and contacts
1 site in 1 country.
France1 site
Departement d'Anesthesie-Reanimation, Hopital Saint-Antoine
Paris, 75012
About this study
Official title: Effect of Local Anesthetic Continuous Preperitoneal Wound Infiltration on Incisional Hyperalgesia Following Colorectal Laparoscopic Surgery
In this multicenter, randomised, placebo-controlled, double-blind trial, hyperalgesia area around the scarce following colorectal laparoscopic surgery (piece removal) will be assessed in 3 groups of patients : group 1: continuous ropivacaine preperitoneal infusion, group 2 : intravenous lidocaine infusion, or group 3 : control group without local anesthetics. All patients will receive parenteral analgesia combining acetaminophen and morphine.
Read the detailed description
Besides hyperalgesia assessment, immediate postoperative and long-term pain, morphine consumption, and endocrin-metabolic response will be evaluated in this study.
- Conditions
- Pain, Postoperative
- Being tested
- continuous ropivacaine preperitoneal infusion, intravenous lidocaine infusion, parenteral analgesia combining acetaminophen and morphine, NaCl
- Keywords
- Pain, postoperative, Local infiltration, Hyperalgesia, postoperative, Local anesthetic, ropivacaine, lidocaine, Colorectal laparoscopic surgery, Pain management after colorectal laparoscopic surgery
- Medical subject headings
- Pain, Postoperative, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous ropivacaine preperitoneal infusionDrug
Bolus of 20 mg after the surgery then 20 mg per hour during 48 hours
intravenous lidocaine infusionDrug
Bolus of 60 mg after the surgery then 60 mg per hour during 48 hours
parenteral analgesia combining acetaminophen and morphineDrug
parenteral analgesia combining acetaminophen and morphine
NaClDrug
NaCl
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients with continuous ropivacaine preperitoneal infusion Receives: Drug: continuous ropivacaine preperitoneal infusion; Drug: parenteral analgesia combining acetaminophen and morphine |
| 2 | Active comparator | Patients with intravenous lidocaine infusion Receives: Drug: intravenous lidocaine infusion; Drug: parenteral analgesia combining acetaminophen and morphine |
| 3 | Placebo comparator | Patients without local anesthetics Receives: Drug: parenteral analgesia combining acetaminophen and morphine; Drug: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pericicatricial hyperalgesia area
Measured: 72 hours after surgery
Secondary outcomes (2)
Pain intensity (rest/mobilization and long-term)
Measured: 72 hours, 3 months and 6 months after surgery
Morphine consumption
Measured: During 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2012
- Study completionFeb 2013
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 Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Beaussier, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077752
- Sponsor's protocol ID
- AOR 08028
- Acronym
- CATCH
- Status last verified
- Jan 2014
- First submitted
- 26 Feb 2010
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Anesthetic Continuous Preperitoneal Wound Infiltration on Incisional Hyperalgesia Following Colorectal Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01077752
- Acronym / sponsor ID
- CATCH / AOR 08028
- Conditions
- Pain, Postoperative
- Keywords
- Pain, postoperative, Local infiltration, Hyperalgesia, postoperative, Local anesthetic, ropivacaine, lidocaine, Colorectal laparoscopic surgery, Pain management after colorectal laparoscopic surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 1 Mar 2010 (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.
In this multicenter, randomised, placebo-controlled, double-blind trial, hyperalgesia area around the scarce following colorectal laparoscopic surgery (piece removal) will be assessed in 3 groups of patients : group 1: continuous ropivacaine preperitoneal infusion, group 2 : intravenous lidocaine infusion, or group 3 : control group without local anesthetics. All patients will receive parenteral analgesia combining acetaminophen and morphine.
Detailed description
Besides hyperalgesia assessment, immediate postoperative and long-term pain, morphine consumption, and endocrin-metabolic response will be evaluated in this study.
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 |
|---|---|---|
| 1 | Experimental | Drug: continuous ropivacaine preperitoneal infusion, Drug: parenteral analgesia combining acetaminophen and morphinePatients with continuous ropivacaine preperitoneal infusion |
| 2 | Active comparator | Drug: intravenous lidocaine infusion, Drug: parenteral analgesia combining acetaminophen and morphinePatients with intravenous lidocaine infusion |
| 3 | Placebo comparator | Drug: parenteral analgesia combining acetaminophen and morphine, Drug: NaClPatients without local anesthetics |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 80
- ASA status 1 - 3
- Colorectal laparoscopic surgery with piece removal
- French speaking
- Written informed consent
Key exclusion criteria (13 listed)
- laparoscopy without colorectal extraction
- chronic pain
- analgesic consumption during the 24 hours previous to the surgery
- morphine and LA intolerance
- drug addiction
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 |
|---|---|---|
| continuous ropivacaine preperitoneal infusionBolus of 20 mg after the surgery then 20 mg per hour during 48 hours | Drug | 1 |
| intravenous lidocaine infusionBolus of 60 mg after the surgery then 60 mg per hour during 48 hours | Drug | 2 |
| parenteral analgesia combining acetaminophen and morphineparenteral analgesia combining acetaminophen and morphine | Drug | 1, 2, 3 |
| NaClNaCl | Drug | 3 |
Primary outcome
Pericicatricial hyperalgesia area
Time frame: 72 hours after surgery
2 secondary outcomes
Pain intensity (rest/mobilization and long-term)
Time frame: 72 hours, 3 months and 6 months after surgery
Morphine consumption
Time frame: During 5 days after surgery
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 22 Jan 2014.
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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.
Marc Beaussier, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing continuous ropivacaine preperitoneal infusion, intravenous lidocaine infusion and parenteral analgesia combining acetaminophen and morphine in people with Pain, Postoperative, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 13 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 22 Jan 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.
What does this phase mean?
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?
Pericicatricial hyperalgesia area (time frame: 72 hours after surgery). 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 22 Jan 2014.