Condition category
Cancer
Date applied
12/02/2015
Date assigned
23/02/2015
Last edited
19/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Lee Jeys

ORCID ID

http://orcid.org/0000-0002-4099-7381

Contact details

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

Type

Scientific

Additional contact

Dr Chris Thorne

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

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.

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

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

01/08/2014

Overall trial end date

01/08/2018

Reason abandoned

Lack of funding/sponsorship

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

80

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

01/04/2015

Recruitment end date

01/04/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Royal Orthopaedic Hospital NHS Foundation Trust

Sponsor details

Bristol Road South
Birmingham
B31 2AP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Orthopaedic Hospital NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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.