A study investigating a continuous local anaesthetic infusion for pain relief after pelvic tumour surgery
| ISRCTN | ISRCTN60374925 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60374925 |
| Protocol serial number | N/A |
| Sponsor | Royal Orthopaedic Hospital NHS Foundation Trust |
| Funder | Royal Orthopaedic Hospital NHS Foundation Trust |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Royal Orthopaedic Hospital NHS Foundation Trust
Bristol Road South
Birmingham
B31 2AP
United Kingdom
| 0000-0002-4099-7381 |
Scientific
Royal Orthopaedic Hospital NHS Foundation Trust
Birmingham
B31 2AP
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| 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. |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
1. Pain score – measured by Numeric Rating Scales (NRS) (0-10) |
| Key secondary outcome measure(s) |
1. Interference with activities (measured by NRS 0-10) |
| 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 | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Birmingham
B31 2AP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Editorial Notes
05/04/2016: This study has been stopped due to lack of funding.