Clinical trial • Not applicable • Gastroenterology
Ropivacaine hydrochloride for Inguinal hernia
Not applicable trial of Ropivacaine hydrochloride for Inguinal hernia.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Inguinal hernia
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 30-08-2024
- First CTIS Authorization Date
- 21-11-2024
Trial design
Randomised, ropivacaine fresenius kabi 7,5 mg/1 ml solution injectable (test; active substance: ropivacaine hydrochloride; route: injection; product maxdailydose 113 mg, maxtotaldose 800 mg) versus nacl 0,9 % b. braun, oplossing voor injectie (placebo; active substance: sodium chloride; route: injection; maxtotaldose 40 ml).-controlled Not applicable trial across 2 sites in Belgium.
- Randomised
- Yes
- Comparator
- Ropivacaine Fresenius Kabi 7,5 mg/1 ml Solution injectable (test; active substance: ropivacaine hydrochloride; route: injection; product maxDailyDose 113 mg, maxTotalDose 800 mg) versus NaCl 0,9 % B. Braun, oplossing voor injectie (placebo; active substance: sodium chloride; route: injection; maxTotalDose 40 ml).
- Target Sample Size
- 80
Eligibility
Recruits 80 Vulnerable population not selected. Participants must provide informed consent; exclusion includes "Patients who did not give their consent for participation in the study". Minors are excluded (inclusion requires age between 18 and 80), so no assent procedures. Subject information and informed consent forms are provided (documents available in French and Dutch)..
- Pregnancy Exclusion
- Patients who are pregnant
- Vulnerable Population
- Vulnerable population not selected. Participants must provide informed consent; exclusion includes "Patients who did not give their consent for participation in the study". Minors are excluded (inclusion requires age between 18 and 80), so no assent procedures. Subject information and informed consent forms are provided (documents available in French and Dutch).
Inclusion criteria
- {"criterion_text":"- ASA I to III patients"}
- {"criterion_text":"- Patients between 18 and 80 years old"}
- {"criterion_text":"- Patients undergoing a laparoscopic inguinal hernia repair operation."}
Exclusion criteria
- {"criterion_text":"- Patients with a BMI > 35 kg/m2"}
- {"criterion_text":"- Redo operations"}
- {"criterion_text":"- Patients with hemodynamic instability, such as “hypovolemia”"}
- {"criterion_text":"- Patients who are pregnant"}
- {"criterion_text":"- Patients labeled with ASA IV"}
- {"criterion_text":"- Patients who have demonstrated hypersensitivity/allergic reaction to “other local anesthetic of the amide type”"}
- {"criterion_text":"- Patients known with a chronic pain syndrome"}
- {"criterion_text":"- Patients known with a polyneuropathy"}
- {"criterion_text":"- Patients taking daily opioids"}
- {"criterion_text":"- Patients younger than 18 years old and older than 80 years old"}
- {"criterion_text":"- Patients who did not give their consent for participation in the study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint was the Numeric Rating Scale (NRS) pain score assessed at multiple post-operative time points.","definition_or_measurement_approach":"Numeric Rating Scale (NRS) pain score assessed at multiple post-operative time points (NRS pain score measurement)."}
Secondary endpoints
- {"endpoint_text":"- The secondary objective is to compare the amount of dipidolor, expressed in milligrams, given in the PACU and the amount of analgesics used at home","definition_or_measurement_approach":"Comparison of amount of dipidolor (expressed in milligrams) administered in the PACU and the amount of analgesics used at home."}
Recruitment
- Planned Sample Size
- 80
- Recruitment Window Months
- 23
- Consent Approach
- Informed consent is required from participants (adults aged 18–80). Exclusion includes lack of consent. Subject information and informed consent forms are available in French and Dutch (documents present: ICF_FR and ICF_NL). No assent procedures (minors excluded).
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 80
Belgium
- Earliest CTIS Part Ii Submission Date
- 28-10-2024
- Latest Decision Or Authorization Date
- 21-11-2024
- Processing Time Days
- 24
- Number Of Sites
- 2
- Number Of Participants
- 80
Sites
- Site Name
- AZ Rivierenland
- Department Name
- Anesthesiology
- Principal Investigator Name
- Sander Maes
- Principal Investigator Email
- info@azr.be
- Contact Person Name
- Sander Maes
- Contact Person Email
- info@azr.be
- Site Name
- UZ Brussel
- Department Name
- Anesthesiology
- Principal Investigator Name
- Domien Vanhonacker
- Principal Investigator Email
- domien.vanhonacker@uzbrussel.be
- Contact Person Name
- Domien Vanhonacker
- Contact Person Email
- domien.vanhonacker@uzbrussel.be
Sponsor
Primary sponsor
- Full Name
- Universitair Ziekenhuis Brussel
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- Ropivacaine Fresenius Kabi 7,5 mg/1 ml Solution injectable
- Active Substance
- Ropivacaine hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- Injection
- Route
- Injection
- Authorisation Status
- Authorised (marketing authorisation number 2010120043, country LU)
- Maximum Dose
- 800 mg
- Investigational Product Name
- NaCl 0,9 % B. Braun, oplossing voor injectie
- Active Substance
- Sodium chloride
- Modality
- Small molecule
- Routes Of Administration
- Injection
- Route
- Injection
- Authorisation Status
- Authorised (marketing authorisation number BE128125, country BE)
- Maximum Dose
- 40 ml
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