Patients undergoing hemi-pelvectomy for pelvic tumours Cancer
Conditions
Interventions
Patients will be randomised to receive one of two possible post-operative catheter infusions for 5 days:
1. Bupivicaine 0.125% infusion at a fixed rate of 10ml/hr.
2. 0.9% Sodium Chloride infusion at
Sponsors
Royal Orthopaedic Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 and over 2. Known diagnosis of a pelvic malignancy (primary or secondary) 3. Undergoing a hemipelvectomy 4. Ability to provide informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Do not consent to participation in the trial 2. Pre-existing pain syndromes that may affect perception of pain 3. History of opioid dependence 4. Previous adverse reaction to local anaesthetic 5. Established hepatic or renal insufficiency (CKD Stage 3 or greater) 6. A pre-existing clinical diagnosis of dementia 7. Pregnancy Withdrawal criteria: 1. Failure to initiate therapy in line with the protocol 2. Unsuccessful insertion of paravertebral block catheter 3. Clinical evidence of wound or catheter infection 4. Adverse reaction to local anaesthetic 5. Respiratory support from invasive ventilation post-operatively
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain score – measured by Numeric Rating Scales (NRS) (0-10) 1.1. Worst pain score 1.2. Least pain score 1.3. Frequency of severe pain (NRS 0-100%) Pain will be measured at 4, 8, 12, 24 hours post-operatively using a validated questionnaire. It will be measured daily between 24 hours - 7 days and then weekly until discharge. A final questionnaire will be administered on the day of discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Interference with activities (measured by NRS 0-10) 1.1. Activities in bed (e.g. turning, sitting up, changing position) 1.2. Breathing deeply/coughing 1.3. Sleep quality 1.4. If out of bed: activities out of bed (e.g. sitting in chair, walking with aids) 2. Side effects of opioid analgesia (measured by NRS 0-10) 2.1. Nausea 2.2. Drowsiness 2.3. Itching 2.4. Dizziness 3. Emotions (measured by NRS 0-10) 3.1. Anxiousness 3.2. Helplessness 4. Satisfaction with analgesia 4.1. Would you have liked more pain relief (Y/N) 4.2. Apart from this study did you receive any information about pain treatment options? (Y/N) 4.3. How satisfied are you with your pain treatment? (measured by NRS 0-10) 4.4. Have you used non-medicinal forms of pain relief? 5. Urinary retention 5.1. Time to urinary catheter removal (days) 5.2. Re-catheterisation within 24 hours of catheter removal (Y/N) 6. Post-operative ileus 6.1. Bowels open? Y/N 6.2. Passed flatus? Y/N 7. Quantity of opioid use for first five days post-operation (mg) 8. Duration of epidural infusion (hours) 9. Duration of intravenous analgesia (hours) 10. Wound infection rates (defined by antibiotics started for wound infection) 11. Time to first ambulation out of bed (days) 12. Length of High Dependency Unit (HDU) Stay (hours) 13. Length of hospital stay (days) The subjective outcome measures will be assessed in the form of a previously validated questionnaire (please see Appendix). This questionnaire will be used in its entirety at 4 hours post-operation and again on the date of discharge. A minimally modified version will be utilised to investigate temporal changes in pain control between these time points. A Research Assistant (RA) will give the correct questionnaires to the patient who will complete them independently. Only in exceptional cases (e.g. patient unable to read, reading glasses not available, patient too weak to fill it in independently) will the researcher read the questions to the patient. The objective measu | — |
Countries
United Kingdom
Outcome results
None listed