Comparison of the potential short and long term benefits of the use of a continuous popliteal nerve block compared to a single shot technique in patients undergoing surgical repair of ankle fractures
| ISRCTN | ISRCTN96057529 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96057529 |
| Secondary identifying numbers | RGHT 000669 |
- Submission date
- 06/08/2009
- Registration date
- 01/10/2009
- Last edited
- 12/06/2014
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
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
Ms Rosemary Hogg
Scientific
Scientific
Department of Anaesthetics & Intensive Care Medicine
Queen's University Belfast
2nd Floor, Mulhouse Building
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
Study information
| Study design | Randomised double blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Comparison of the effects of single or continuous popliteal nerve block on post-operative outcome measures in patients undergoing operative repair of ankle fracture: a randomised controlled double-blind trial |
| Study objectives | Does the use of a continuous popliteal nerve block after ankle fracture surgery reduce the incidence of chronic post-surgical ankle pain? |
| Ethics approval(s) | Health and Social Care Research Ethics Committee 2 (HSC REC 2) approved on the 28th July 2009 (ref: 09/NIR02/38) |
| Health condition(s) or problem(s) studied | Surgical repair of ankle fracture |
| Intervention | Single shot popliteal nerve block followed by randomisation to receive either a continuous popliteal nerve block using 0.125% levobupivacaine or placebo infusion. For each patient, in hospital follow up will continue for 48 hours after their surgical procedure. Patients will then be contacted at 3 months post-procedure and asked to fill in a repeat Magill pain questionnaire. This will be the end of the study for this patient. Added 09/08/2011: Study did not commence due to issues with equipment & funding |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Reduction in the incidence of chronic ankle pain at three months post-procedure |
| Secondary outcome measures | 1. Post-operative morphine usage assessed at designated times in the post-operative period: one hour after surgery before leaving the recovery area and at 4, 8, 12, 16, 24, 30, 36 and 48 hours after the procedure 2. Time to first mobilisation, recorded at time to first mobilisation 3. Difference in pain scores in both the post-operative period and on first mobilisation assessed at designated times in the post-operative period: one hour after surgery before leaving the recovery area and at 4, 8, 12, 16, 24, 30, 36 and 48 hours after the procedure and on first mobilisation 4. Total length of hospital stay, recorded from the day of admission to day of discharge 5. Patient satisfaction assessed at the end of the 48 hour post-operative period using the 40-item quality of recovery (QoR-40) questionnaire |
| Overall study start date | 17/08/2009 |
| Completion date | 29/04/2010 |
| Reason abandoned (if study stopped) | Lack of funding/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 patients divided into two groups of 30 |
| Key inclusion criteria | 1. American Society of Anaesthesiologists (ASA) class I - III 2. Patients able to give written informed consent 3. Patients awaiting operative repair of an ankle fracture 4. Aged between 18 - 80 years, either sex |
| Key exclusion criteria | 1. History of an allergy to any of the medications used in the study 2. Pregnancy 3. Local infection at site of nerve blockade 4. Any form of neurological dysfunction in lower limbs 5. Patients suffering from severe hypotension such as cardiogenic or hypovolaemic shock or with a serious cardiac arrhythmia |
| Date of first enrolment | 17/08/2009 |
| Date of final enrolment | 29/04/2010 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Department of Anaesthetics & Intensive Care Medicine
Belfast
BT12 6BJ
United Kingdom
BT12 6BJ
United Kingdom
Sponsor information
Belfast Health and Social Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
United Kingdom
| Website | http://www.belfasttrust.hscni.net/ |
|---|---|
"ROR" |
https://ror.org/02tdmfk69 |
Funders
Funder type
Government
Belfast Health and Social Care Trust (UK) (ref: RGHT 000669)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
