Post operative pain relief following knee replacement

ISRCTN	ISRCTN42045594
DOI	https://doi.org/10.1186/ISRCTN42045594
Secondary identifying numbers	N/A

Submission date: 16/02/2012
Registration date: 06/06/2012
Last edited: 14/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mr George McLauchlan
Scientific

Lancashire Teaching Hospitals NHS Foundation Trust
Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom

Phone	+44 (0)1772 522 479
Email	George.McLauchlan@lthtr.nhs.uk

Study information

Study design	Randomised control trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study objectives	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(s)	NRES Committee Northwest Preston, 15/03/2012, ref: 12/NW/0153
Health condition(s) or problem(s) studied	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
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 study start date	15/05/2012
Completion date	15/07/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40
Key inclusion criteria	Patients having a total knee arthroplasty between the dates of May 2012- July 2012 who have capacity to consent
Key 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
Date of first enrolment	15/05/2012
Date of final enrolment	15/07/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Lancashire Teaching Hospitals NHS Foundation Trust

Preston
PR2 9HT
United Kingdom

Sponsor information

Lancashire Teaching Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Royal Preston Hospital
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
England
United Kingdom

Website	http://www.lancsteachinghospitals.nhs.uk/
"ROR"	https://ror.org/02j7n9748

Funders

Funder type

Hospital/treatment centre

Lancashire Teaching Hospitals NHS Foundation Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2013		Yes	No

Editorial Notes

14/02/2019: Publication reference added.
12/02/2018: No publications found, verifying study status with principal investigator.