Post-operative pain Surgery Post-operative Pain Management
Conditions
Interventions
The study interventions being compared, are:
1. Epidural analgesia as per the anaesthetist’s usual practice and as per hospital protocol. Post-operative infusion will be with one of th
0.1%+ fentanyl 2 mcg/ml
0.125% + fentanyl 4 mcg/ml) in routine use in TLC.
2. Wound infusion (ropivacaine 2mg/ml i.e. 0.2% at 5ml/hour) via a multi-hole catheter, using the ReadyfusOR. After wound closure at
Sponsors
BioQ Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient’s average daily and worst pain scores is measured using a NRS (0-10) at screening, 24 hours post-surgery, 48 hours post surgery, 7-9 days after surgery (5-7 days post treatment) 2. OneDose ReadyfusOR or epidural attributable or opioid related side-effects or complications recorded by staff. Measurements are recorded when complication occurs and is not limited to time intervals. The complications recorded include, but are not limited to analgesia trouble shooting, accidental disconnections, bag changes, adverse event recording (e.g. nausea, itching, hypotension, respiratory depression, constipation) and rescue drug requirements 3. Total dose in morphine equivalent dosage (MED) for opioid rescue analgesics. Comparisons will be made to documented opioid sparing effects when the OneDose ReadyfusOR is used for the treatment of post-operative pain, or to PCA only patients. Rescue medication is noted at all time intervals when medication was required. Measurements include rescue drug name, drug dose, frequency of medication, route of administration, start and stop date and time, additional equipment required for treatment, staff involved in intervention, and reported time taken to administer medication. 4. The patients’ evaluations of impact on mobility is measured using a patient satisfaction questionnaire with responses recorded based on numerical scale (0-10), where 0 indicates pain does not interfere or prevent the patient from performing specific activities, and 10 indicates that pain completely interferes at 24 hours post-surgery, 48 hours post surgery, 7-9 days after surgery (5-7 days post treatment) 5. Staff members’ evaluations of ease-of-use and impact on mobility is measured using a patient satisfaction questionnaire with responses recorded based on numerical scale (0-10) at 24 hours post-surgery, 48 hours post surgery, 7-9 days after surgery (5-7 days post treatment | — |
Countries
United Kingdom
Contacts
Public ContactJosh Kriesel
Outcome results
None listed