Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mr Lee Jeys


Contact details

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



Additional contact

Dr Chris Thorne


Contact details

Royal Orthopaedic Hospital NHS Foundation Trust
B31 2AP
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A randomised, triple-blind, placebo controlled trial evaluating the analgesic efficacy of continuous paravertebral block (PVB) following hemipelvectomy for pelvic tumours.


Study hypothesis

Does a PVB block following hemipelvectomy provide better analgesia than the current treatment protocol?

Ethics approval

South Birmingham Research Ethics Committee - submitted as of 20/02/2015

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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Patients undergoing hemi-pelvectomy for pelvic tumours


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



Not Applicable

Drug names

Primary outcome measures

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 trial start date


Overall trial end date


Reason abandoned

Lack of funding/sponsorship


Participant 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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information


Royal Orthopaedic Hospital NHS Foundation Trust

Sponsor details

Bristol Road South
B31 2AP
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Royal Orthopaedic Hospital NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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