Phase
Condition
N/ATreatment
ORE001
Placebo
Clinical Study ID
Ages 18-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient must be able to understand the requirements of the study and give writteninformed consent prior to study start.
Female patients aged between 18 and 75 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).
Exclusion
Exclusion Criteria:
Patient has a history of gastrectomy, total colectomy, stoma creation, short bowelsyndrome.
Patient has pre-operative ileus.
Patient is taking opioid analgesics longer than two post-operative days, exceeding adosing of 35 mg morphine equivalent per day.
Chemotherapy treatment within 10 days after longitudinal surgery.
Smoking during the hospital stay.
Any contraindication as per summary of product characteristic for the usage of localanesthetics for PDC.
History of uncontrolled (at the discretion of the Investigator) cardiovascular,renal and/or hepatic failure.
History of severe allergic or anaphylactic reactions, especially to localanesthetics.
Clinically significant (at the discretion of the Investigator) deviation from thenormal 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 tostudy medication administration.
Experimental agent within 30 days or ten half-lives, whichever is longer, prior tostudy medication administration.
Pregnancy or planning to become pregnant during the study.
Any other condition, which in the opinion of the Investigator precludes thepatient's participation in the study.
Patients with close affiliation with the Investigator or persons working at therespective study sites or patients who are an employee of the Sponsor.
Study Design
Study Description
Connect with a study center
Universitätsklinikum Bonn (UKB).
Bonn,
GermanyActive - Recruiting
Kaiserswerther Diakonie Florence-Nightingale- Krankenhaus
Dusseldorf, 40489
GermanyActive - Recruiting
Klinikum Wolfsburg
Wolfsburg, 38440
GermanyActive - Recruiting
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