Condition category
Surgery
Date applied
16/02/2012
Date assigned
06/06/2012
Last edited
17/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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.
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.

Who can participate?
Any patient due to undergo a total knee replacement at the Lancashire Teaching Hospital between May and July 2012 is suitable to take part in this study.

What does the study involve?
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

When is study starting and how long is it expected to run for?
Study started in May2012 and will run till July 2012.

Who is funding the study?
The study is funded by Lancashire Teaching Hospitals NHS Foundation Trust.

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 March 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 below 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 measures

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

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

http://www.lancsteachinghospitals.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

17/11/2015: No publications found on PubMed.