A study investigating a continuous local anaesthetic infusion for pain relief after pelvic tumour surgery

ISRCTN	ISRCTN60374925
DOI	https://doi.org/10.1186/ISRCTN60374925
Secondary identifying numbers	N/A

Submission date: 12/02/2015
Registration date: 23/02/2015
Last edited: 19/05/2016

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Lee Jeys
Scientific

Royal Orthopaedic Hospital NHS Foundation Trust
Bristol Road South
Birmingham
B31 2AP
United Kingdom

ORCID ID	0000-0002-4099-7381

Dr Chris Thorne
Scientific

Royal Orthopaedic Hospital NHS Foundation Trust
Birmingham
B31 2AP
United Kingdom

Study information

Study design	A prospective, randomised, triple-blind, placebo-controlled trial comparing the effects of continuous LA infusion with a placebo infusion of 0.9% sodium chloride following hemipelvectomy. This is a single centre study at the Royal Orthopedic Hospital, Birmingham.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A randomised, triple-blind, placebo controlled trial evaluating the analgesic efficacy of continuous paravertebral block (PVB) following hemipelvectomy for pelvic tumours.
Study objectives	Does a PVB block following hemipelvectomy provide better analgesia than the current treatment protocol?
Ethics approval(s)	South Birmingham Research Ethics Committee - submitted as of 20/02/2015
Health condition(s) or problem(s) studied	Patients undergoing hemi-pelvectomy for pelvic tumours
Intervention	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 a fixed rate of 10ml/hr. This will be in addition to standard post-operative analgesia which encompasses combined epidural and spinal anaesthetic, and patient controlled analgesia.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 outcome measures	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 measures will be obtained by review of the patients’ medical notes.
Overall study start date	01/08/2014
Completion date	01/08/2018
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	80
Key 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
Key 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
Date of first enrolment	01/04/2015
Date of final enrolment	01/04/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The Royal Orthopaedic Hospital NHS Foundation Trust

Bristol Road South
Birmingham
B31 2AP
United Kingdom

Sponsor information

Royal Orthopaedic Hospital NHS Foundation Trust
Hospital/treatment centre

Bristol Road South
Birmingham
B31 2AP
England
United Kingdom

"ROR"	https://ror.org/03dx46b94

Funders

Funder type

Hospital/treatment centre

Royal Orthopaedic Hospital NHS Foundation Trust

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan
IPD sharing plan

Editorial Notes

05/04/2016: This study has been stopped due to lack of funding.