Pain, AcuteNCT05173090
Influence of Intra-abdominal Ropivacaine 0.5% Spray on Postoperative Analgesia in Laparoscopic Surgery.
A study testing Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery in people with Pain, Acute, run by University of Liege.
Trial summary
Assessing postoperative pain after ropivacin 0.5% spray in the abdominal cavity during laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2022to 30 Jul 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Appendectomy or cholecystectomy surgery
Who cannot join
- Allergy to local anesthetics
- Intolerance to tramadol HCl
- Patient with peritonitis
- Pregnant women
- Surgery without laparoscopy
- Chronic pain before the operation
Trial locations and contacts
No sites are listed yet.
About this study
Assessing postoperative pain after ropivacin 0.5% spray in the abdominal cavity during laparoscopic surgery.
- Conditions
- Pain, Acute
- Being tested
- Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaïne 0,5% for appendectomy or cholecystectomy surgeryDrug
Visual analog scale 15 min after arrival in the recovery room, then H+4, H+6, H+12, H+24 and one week after the operation
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaïne 0,5% | Active comparator | 3 mg/kg of ropivacaine 0.5% sprayed into the abdominal cavity Receives: Drug: Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery |
| NaCl 0,9% | Placebo comparator | NaCl 0,9% sprayed into the abdominal cavity Receives: Drug: Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's pain
The patient's satisfaction was assessed by visual analog scale, ranging from one (worse outcome )to four (better outcome
Measured: During appendectomy and cholecystectomy surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start15 Jan 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Javillier, MD, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173090
- Sponsor's protocol ID
- Ropicoelio
- Status last verified
- Nov 2021
- First submitted
- 29 Nov 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Intra-abdominal Ropivacaine 0.5% Spray on Postoperative Analgesia in Laparoscopic Surgery.
- ClinicalTrials.gov ID
- NCT05173090
- Acronym / sponsor ID
- Ropicoelio
- Conditions
- Pain, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 15 Jan 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 29 Dec 2021 (actual)
- 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.
Assessing postoperative pain after ropivacin 0.5% spray in the abdominal cavity during laparoscopic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaïne 0,5% | Active comparator | Drug: Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery3 mg/kg of ropivacaine 0.5% sprayed into the abdominal cavity |
| NaCl 0,9% | Placebo comparator | Drug: Ropivacaïne 0,5% for appendectomy or cholecystectomy surgeryNaCl 0,9% sprayed into the abdominal cavity |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Appendectomy or cholecystectomy surgery
Key exclusion criteria (6 listed)
- Allergy to local anesthetics
- Intolerance to tramadol HCl
- Patient with peritonitis
- Pregnant women
- Surgery without laparoscopy
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 |
|---|---|---|
| Ropivacaïne 0,5% for appendectomy or cholecystectomy surgeryVisual analog scale 15 min after arrival in the recovery room, then H+4, H+6, H+12, H+24 and one week after the operation | Drug | NaCl 0,9%, Ropivacaïne 0,5% |
Primary outcome
Patient's pain
Time frame: During appendectomy and cholecystectomy surgery
The patient's satisfaction was assessed by visual analog scale, ranging from one (worse outcome )to four (better outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaïne 0,5% for appendectomy or cholecystectomy surgery in people with Pain, Acute, run by University of Liege.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Javillier, MD (+32498573882, javillier.benjamin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's pain (time frame: During appendectomy and cholecystectomy 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 29 Dec 2021.