ISRCTN10488559Recruiting未知
Pilot healthcare economics and observational study of the OneDose ReadyfusOR (a factory-filled infusion device delivering a continuous infusion of ropivacaine 2mg/ml for up to 48 hours), for the treatment of post-operative pain in patients who have undergone open intra-abdominal surgery (laparotomy)
BioQ Pharma0 sites20 target enrollmentStarted: November 6, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Participant is willing and able to give informed consent for participation in the study
- •2. Male or Female, aged 18 years or above
- •3. Adult patients = 18 years of age scheduled to undergo a laparotomy
- •4. Able (in the Investigators opinion) and willing to comply with all study requirements
- •5. Able to understand and provide signed informed consent, and to answer the study related questions
- •6. Normally active, and judged to be in stable health (ASA I-III: Healthy person; or mild or stable systemic disease) on the basis of routine pre-surgery assessment: medical history, physical examination and standard care investigations
- •7. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- •8. Participant has clinically acceptable laboratory and ECG findings
- •9. Willing to allow his or her General Practitioner (GP) and consultant, if appropriate, to be notified of participation in the study
Exclusion Criteria
- •1. Female participant who is pregnant, or lactating, during the course of the study
- •2. History of allergy to study related drugs, which would preclude all of the possible combinations, capable of providing usual care multimodal analgesia: other local anaesthetics, morphine, oxycodone, fentanyl, paracetamol
- •3. Significant renal or hepatic impairment
- •4. Clinically significant illness or surgery within 1 week prior to screening visit (including flu, flu like symptoms, diarrhea, vomiting, ongoing sepsis/bacterial infections)
- •5. Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 160 mmHg, diastolic blood pressure lower than 40 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- •6. Chronic pain, with or without long-term regular analgesic usage
- •7. History of substance abuse
- •8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study
- •9. Participants who have participated in another research study involving an investigational product in the past 12 weeks.
- •10. Current or recent (in the last 30 days) inclusion in another research study.
- •NOTE: If the patient has a history of allergy to ropivicaine, but is known to tolerate laevo-bupivicaine, then epidural analgesia remains a viable option, if deemed acceptable by the patient and anaesthetist. They will not be eligible for treatment with the RF, which contains ropivicaine.
Investigators
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