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Efficacy of oral lidocaine in preventing gastrointestinal disturbance in patients after abdominal surgery
EU CTIS ID: 2022-503113-31-01
What this study is testing
To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD3.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient must be able to understand the requirements of the study and give written informed consent prior to study start.
- Female patients aged between 18 and 79 years (both inclusive).
- Gynecologic surgery performed completely by longitudinal laparotomy.
- Patient with ECOG Performance status up to 1.
- Patient is highly likely to comply with the protocol and complete the study.
- Patient agrees to be scheduled for peridural catheter (PDC).
You likely can't join if
- Patient has a history of gastrectomy, total colectomy, stoma creation, short bowel syndrome.
- Patient is taking opioid analgesics longer than two post-operative days, exceeding a dosing of 35 mg morphine equivalent per day.
- Chemotherapy treatment within 10 days after longitudinal surgery.
- Any contraindication as per summary of product characteristic for the usage of local anesthetics for PDC.
- History of uncontrolled (at the discretion of the Investigator) cardiovascular, renal, hepatic and/or liver failure.
- History of severe allergic or anaphylactic reactions, especially to local anesthetics.
See the full eligibility criteria
- Patient must be able to understand the requirements of the study and give written informed consent prior to study start.
- Female patients aged between 18 and 79 years (both inclusive).
- Gynecologic surgery performed completely by longitudinal laparotomy.
- Patient with ECOG Performance status up to 1.
- Patient is highly likely to comply with the protocol and complete the study.
- Patient agrees to be scheduled for peridural catheter (PDC).
- Patient has a history of gastrectomy, total colectomy, stoma creation, short bowel syndrome.
- Patient is taking opioid analgesics longer than two post-operative days, exceeding a dosing of 35 mg morphine equivalent per day.
- Chemotherapy treatment within 10 days after longitudinal surgery.
- Any contraindication as per summary of product characteristic for the usage of local anesthetics for PDC.
- History of uncontrolled (at the discretion of the Investigator) cardiovascular, renal, hepatic and/or liver failure.
- History of severe allergic or anaphylactic reactions, especially to local anesthetics.
- Clinically significant (at the discretion of the Investigator) deviation from the normal laboratory values.
- Clinically significant (at the discretion of the Investigator) abnormal ECG.
- Intake of any class 1B antiarrhythmic drugs if used for antiarrhythmic purpose (e.g., Lidocaine, Mexiletine, Phenytoin) and of any class 3 antiarrhythmic drugs - Kalium channel blockers (e.g., Amiodarone, Dronedarone, Sotalol, Ibutilide, Dofetilide, Bretylium).
- Significant (at the discretion of the Investigator) symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection (especially with need of antibiotic treatment) within the past 2 weeks prior to study medication administration.
- Experimental agent within 30 days or ten half-lives, whichever is longer, prior to study medication administration.
- Pregnancy or planning to become pregnant or nursing during the study.
- Any other condition, which in the opinion of the Investigator precludes the patient’s participation in the study.
- Patients with close affiliation with the Investigator or persons working at the respective study sites or patients who are an employee of the Sponsor.
- Patient has pre-operative ileus.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.