Post operative pain relief following knee replacement
| ISRCTN | ISRCTN42045594 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42045594 |
| Protocol serial number | N/A |
| Sponsor | Lancashire Teaching Hospitals NHS Foundation Trust (UK) |
| Funder | Lancashire Teaching Hospitals NHS Foundation Trust (UK) |
- 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
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
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 |
|---|---|
| George.McLauchlan@lthtr.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised control trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Pain scores in the two patient groups, recorded 4 hours post operatively, before and after physiotherapy |
| Key secondary outcome measure(s) |
1. The amount of patient-controlled pain relief used |
| Completion date | 15/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
PR2 9HT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/02/2019: Publication reference added.
12/02/2018: No publications found, verifying study status with principal investigator.
