Condition category
Surgery
Date applied
06/08/2009
Date assigned
01/10/2009
Last edited
12/06/2014
Prospective/Retrospective
Retrospectively 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

Ms Rosemary Hogg

ORCID ID

Contact details

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

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

http://www.belfasttrust.hscni.net/

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

Publication citations

Additional files

Editorial Notes