SurgeryPhase 3VSDNCT02819544
Evaluation of the Interest of the Instillation of Saline Intraperitoneally (INSI ) Versus Instillation of Naropin the Surgical Site Versus Lung Recruitment Maneuvers ( PVM ) in the Management of Pain After Laparoscopic Cholecystectomy in Ambulatory Care
A Phase 3 study testing Sodium chloride administration and Ropivacaine administration in people with Surgery and Pain, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
Trial summary
Known to reduce analgesics and length of hospitalization in conventional surgery, laparoscopy is characterized by frequent post-operative pain and can decrease the patient's quality of immediate postoperative life and sometimes the results of decision ambulatory care. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Sodium chloride administration and Ropivacaine administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2016to 10 May 2017
- 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
- Patient aged 18 to 80 years
- Patients with biliary pathology requiring cholecystectomy
- Patients with signed consent
- Patient eligible to outpatient care
- No allergy to Naropin
- Support by laparoscopy
- Patients affiliated to a social security s
Who cannot join
- Contraindications for laparoscopy
- Contraindications to outpatient surgery
- Patients with an allergy to paracetamol or tramadol
- Patient with an addiction to painkillers and / or alcohol
- Patient with a disease causing chronic pain
- Patient using analgesics bearing 1 , 2 or 3 chronically
Show all 10Show fewer
- Pregnant or breastfeeding women , of reproductive age without effective contraception
- Minor Patient,
- Contraindication to surgery,
- Physical or psychological state does not allow the patient's participation in the study ,
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Prospective, Two-center , Randomized, ITT , Parallel Group Evaluating the Interest of the Instillation of Saline Intraperitoneally (INSI ) Versus Instillation of Naropin the Surgical Site Versus Lung Recruitment Maneuvers ( PVM ) in the Management of Pain After Laparoscopic Cholecystectomy in Ambulatory Care
Known to reduce analgesics and length of hospitalization in conventional surgery, laparoscopy is characterized by frequent post-operative pain and can decrease the patient's quality of immediate postoperative life and sometimes the results of decision ambulatory care.
In order to reduce these postoperative pain, various methods have been evaluated in numerous studies to determine their analgesic role.
Read more
As part of abdominal surgery, local anesthetics (Naropin (Ropivacaine)) are generally administered in the end of surgery to reduce postoperative pain and promote recovery of the patient. In addition, it is also possible to instill the anesthetic directly into the abdominal cavity reducing pain transmitted by nociceptor viscera.
In recent years, new methods have been proposed such as lung recruitment maneuvers and the instillation of saline solution to reduce postoperative pain.
However, no recommendation is on the use of intraperitoneal saline under the management of postoperative pain after laparoscopic cholecystectomy in ambulatory care.
- Being tested
- Sodium chloride administration, Ropivacaine administration
- Keywords
- Digestive System
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium chloride administrationDrug
Sodium chloride administration
Ropivacaine administrationDrug
Ropivacaine administration
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Active comparator | Ropivacaine 7.5 mg/mL administration Receives: Drug: Ropivacaine administration |
| Sodium chloride | Placebo comparator | NaCl 0.9% administration Receives: Drug: Sodium chloride administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured by visual analog scale (VAS)
Measured: between first postoperative day and 6th postoperative day
Secondary outcomes (4)
global pain measured by BPI (Brief Pain Inventory) scale
Measured: 30th postoperative day
analgesics use
Measured: 30th postoperative day
global morbidity
Measured: 30th postoperative day
specific complications for each treatment
Measured: 30th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startSep 2016
- Primary completion10 May 2017
- Study completion10 May 2017
Why it stopped: investigator choice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc REGIMBEAU, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819544
- Sponsor's protocol ID
- PI2015_843_0020
- Acronym
- VSD
- Status last verified
- Jul 2020
- First submitted
- 28 Jun 2016
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Two-center , Randomized, ITT , Parallel Group Evaluating the Interest of the Instillation of Saline Intraperitoneally (INSI ) Versus Instillation of Naropin the Surgical Site Versus Lung Recruitment Maneuvers ( PVM ) in the Management of Pain After Laparoscopic Cholecystectomy in Ambulatory Care
- ClinicalTrials.gov ID
- NCT02819544
- Acronym / sponsor ID
- VSD / PI2015_843_0020
- Keywords
- Digestive System
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: investigator choice
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 30 Jun 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.
Known to reduce analgesics and length of hospitalization in conventional surgery, laparoscopy is characterized by frequent post-operative pain and can decrease the patient's quality of immediate postoperative life and sometimes the results of decision ambulatory care.
In order to reduce these postoperative pain, various methods have been evaluated in numerous studies to determine their analgesic role.
As part of abdominal surgery, local anesthetics (Naropin (Ropivacaine)) are generally administered in the end of surgery to reduce postoperative pain and promote recovery of the patient. In addition, it is also possible to instill the anesthetic directly into the abdominal cavity reducing pain transmitted by nociceptor viscera.
In recent years, new methods have been proposed such as lung recruitment maneuvers and the instillation of saline solution to reduce postoperative pain.
However, no recommendation is on the use of intraperitoneal saline under the management of postoperative pain after laparoscopic cholecystectomy in ambulatory care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Active comparator | Drug: Ropivacaine administrationRopivacaine 7.5 mg/mL administration |
| Sodium chloride | Placebo comparator | Drug: Sodium chloride administrationNaCl 0.9% administration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient aged 18 to 80 years
- Patients with biliary pathology requiring cholecystectomy
- Patients with signed consent
- Patient eligible to outpatient care
- No allergy to Naropin
Key exclusion criteria (10 listed)
- Contraindications for laparoscopy
- Contraindications to outpatient surgery
- Patients with an allergy to paracetamol or tramadol
- Patient with an addiction to painkillers and / or alcohol
- Patient with a disease causing chronic pain
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 |
|---|---|---|
| Sodium chloride administrationSodium chloride administration | Drug | Sodium chloride |
| Ropivacaine administrationRopivacaine administration | Drug | Ropivacaine |
Primary outcome
Pain measured by visual analog scale (VAS)
Time frame: between first postoperative day and 6th postoperative day
4 secondary outcomes
global pain measured by BPI (Brief Pain Inventory) scale
Time frame: 30th postoperative day
analgesics use
Time frame: 30th postoperative day
global morbidity
Time frame: 30th postoperative day
specific complications for each treatment
Time frame: 30th postoperative day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
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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.
Jean-Marc REGIMBEAU, MD, PhD principal investigator
CHU Amiens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium chloride administration and Ropivacaine administration in people with Surgery and Pain, run by Centre Hospitalier Universitaire, Amiens at 2 sites 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 7 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: withdrawn, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Pain measured by visual analog scale (VAS) (time frame: between first postoperative day and 6th postoperative day). 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 17 Jul 2020.