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
Protocol serial number	RGHT 000669
Sponsor	Belfast Health and Social Care Trust (UK)
Funder	Belfast Health and Social Care Trust (UK) (ref: 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

Department of Anaesthetics & Intensive Care Medicine
Queen's University Belfast
2nd Floor, Mulhouse Building
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised double blind controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Reduction in the incidence of chronic ankle pain at three months post-procedure
Key secondary outcome measure(s)	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
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	All
Target sample size at registration	60
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

United Kingdom
Northern Ireland

Study participating centre

Department of Anaesthetics & Intensive Care Medicine

Belfast
BT12 6BJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes