Readyfusor health economics study

Not Applicable

Recruiting

• Conditions: Post-operative pain; Surgery; Post-operative Pain Management

• Registration Number: ISRCTN10488559
• Lead Sponsor: BioQ Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-06
• Last Update Posted: 29 April 2019
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Healthcare costs are measured using the health economics items starting with a standardised time for preparation of epidural or TAP block materials (based on timed simulations of each of the two preparations), followed by the real-time data collection commencing from the time of the patient’s arrival in the anaesthetic room.<br><br> The contributions associated with the pain relief method in relation to staff time and costs of materials and equipment will be collected during the study by recording and timing the members of staff involved in the preparation, before theatre and in-theatre; and catheter placement of post-operative pain relief in-theatre. In the 48hour period post-surgery, contributions in relation to staff time and cost, materials and equipment will be determined from the patient’s case notes. The staff time, materials and equipment will be logged in physical units and translated into costs using published unit costs.<br>