Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RGHT 000669
Study information
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
Acronym
Study hypothesis
Does the use of a continuous popliteal nerve block after ankle fracture surgery reduce the incidence of chronic post-surgical ankle pain?
Ethics approval
Health and Social Care Research Ethics Committee 2 (HSC REC 2) approved on the 28th July 2009 (ref: 09/NIR02/38)
Study design
Randomised double blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
17/08/2009
Overall trial end date
29/04/2010
Reason abandoned
Lack of funding/resources
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60 patients divided into two groups of 30
Participant 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
Recruitment start date
17/08/2009
Recruitment end date
29/04/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthetics & Intensive Care Medicine
Belfast
BT12 6BJ
United Kingdom
Sponsor information
Organisation
Belfast Health and Social Care Trust (UK)
Sponsor details
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Belfast Health and Social Care Trust (UK) (ref: RGHT 000669)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary