Plain English Summary
Background and study aims
The aim of this study is to help us better understand the ways in which we can manage pain in patients who have had a knee replacement. There are various methods of pain relief; all of these treatments have been shown to work well. Currently, the treatment depends on the surgeons preference. This project will compare two methods of pain relief to see if patients experience less pain and are more mobile, with one method above another.
Who can participate?
Any patient due to undergo a total knee replacement at the Lancashire Teaching Hospital
What does the study involve?
Patients will be randomly put into one of the two groups, and each group will receive a different method of pain relief to cover the period following the operation. One group will be given a femoral nerve block, which is a type of local anaesthetic which numbs the area of the thigh and knee. This will involve an Anesthetist giving an injection into the nerve, which lies in the upper part of the leg. The other group will receive an injection that contains pain relieving drugs into the joint itself at the time of surgery. This will be done by the surgeon. All participants will be asked to report their pain scores at various intervals, so that these can be recorded. Other information which will be documented will include:
The amount of the pain relieving medication used after the operation.
The time it takes to work through physiotherapy goals.
The time it takes to recover in hospital after the operation.
What are the possible benefits and risks of participating?
We cannot promise that patients will gain any immediate benefit from taking part in the research. However, the information gathered will help improve the care of patients who have knee replacements in the future. There are no major risks associated with this research study. The risks of having knee replacement surgery will have been discussed with you by the surgeon.
Where is the study run from?
Lancashire Teaching Hospital (UK)
When is the study starting and how long is it expected to run for?
May 2012 to July 2012
Who is funding the study?
Lancashire Teaching Hospitals NHS Foundation Trust (UK)
Who is the main contact?
Mr George McLauchlan
George.McLauchlan@lthtr.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mr George McLauchlan
ORCID ID
Contact details
Lancashire Teaching Hospitals NHS Foundation Trust
Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
+44 (0)1772 522 479
George.McLauchlan@lthtr.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Post operative pain relief following knee arthroplasty - an exploratory study comparing the efficacy of a single shot femoral nerve block against intra-articular analgesic injection
Acronym
Study hypothesis
The two methods of pain relief being compared are femoral nerve blocks, which cause numbing of the thigh and knee, versus the use of injections which contain drugs used for pain relief into the knee joint.
To measure which method is more effective, we will be measuring the following:
1. The pain scores of patients
2. The amount of patient-controlled pain relief used
3. The time taken to achieve physiotherapy goals.
4. The length of stay in hospital
Ethics approval
NRES Committee Northwest Preston, 15/03/2012, ref: 12/NW/0153
Study design
Randomised control 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 to request a patient information sheet
Condition
Knee arthroplasty
Intervention
Randomised control trial looking at single shot femoral nerve blocks versus Intra articular injections. The data will be analysed using stats direct and MS Excel.
Prior to surgery, patients will be randomly allocated to either group A or group B. Group A will receive a one shot femoral nerve block containing 30ml or 0.2% ropivacaine post surgery.
Group B will receive a single intra articular knee injection containing 200ml 0.2% ropivacaine, 1ml 1:1000 adrenaline and 30mg ketolorac.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Pain scores in the two patient groups, recorded 4 hours post operatively, before and after physiotherapy
Secondary outcome measures
1. The amount of patient-controlled pain relief used
2. The time taken to achieve physiotherapy goals
3. The length of stay in hospital
Overall trial start date
15/05/2012
Overall trial end date
15/07/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients having a total knee arthroplasty between the dates of May 2012- July 2012 who have capacity to consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Any patients that lack capacity to consent to the study
2. Patients who are unwilling to consent.
3. Patients who may be acutely confused or suffer from dementia
4. Patients who have a known allergy, intolerance or previous reaction to any of the drugs being administered
Recruitment start date
15/05/2012
Recruitment end date
15/07/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Lancashire Teaching Hospitals NHS Foundation Trust
Preston
PR2 9HT
United Kingdom
Sponsor information
Organisation
Lancashire Teaching Hospitals NHS Foundation Trust (UK)
Sponsor details
Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Lancashire Teaching Hospitals NHS Foundation Trust (UK)
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
Basic results (scientific)
Publication list