Ignite Creation Date:
2024-05-06 @ 3:24 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02288923
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2014-11-04
Brief Title:
Trial to Compare Femoral Nerve Block With Local Anaesthetic Injection for Post-operative Pain After Knee Replacement
Sponsor:
Royal Devon and Exeter NHS Foundation Trust
Organization:
Royal Devon and Exeter NHS Foundation Trust
Study Overview
Official Title:
A Randomised Observer Blinded Controlled Trial Of Femoral Nerve Block Versus Local Infiltration Analgesia for Post Operative Analgesia Following Total Knee Arthroplasty
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIFT
Brief Summary:
Pain after a knee replacement can impair recovery and use of the new knee Having an injection to numb the femoral nerve is known to give good pain relief after the operation but may lead to slower mobilisation as it also prevents the patient from moving the knee Recent studies have shown that infiltration of local anaesthetic LIA within the new knee joint may also give good pain relief The null hypothesis is that there is no difference in primary or secondary outcome measures between femoral nerve block and LIA as anaesthetic techniques for knee replacement
Detailed Description:
Knee pain and stiffness is a common problem which can sometimes be improved by inserting a replacement knee joint An anaesthetist is a doctor who specialises in looking after patients undergoing surgery and there are a variety of different anaesthetics which can be used for knee replacement surgery These include general anaesthesia going to sleep and spinal or epidural anaesthesia where pain killers are injected into the back resulting in temporarily numb legs Pain killers can also be injected around the nerves which supply the leg or around the site of the operation itself combined with general or spinal anaesthesia if required
Over the years multiple different combinations of these techniques have been tried All have advantages and disadvantages Generally those which completely numb the leg after the operation often cause weakness which interferes with movement Although the patient will have no pain getting up and around with the physiotherapist is crucial and the weakness can delay recovery However excessive pain can also interfere with movement There is therefore a balance to be struck between pain and weakness and the choice of anaesthetic technique is key
Researchers previously conducted a study at the Royal Devon and Exeter Hospital which compared the effects of two techniques the use of diamorphine in a spinal injection and the injection of pain killer around a nerve supplying the leg femoral nerve block FNB Whilst the research showed that FNB gave better pain relief there are still concerns that it causes weakness which may interfere with movement A newer technique has evolved over recent years in which pain killer is injected directly around the knee during the operation This is known as local infiltration analgesia LIA and the potential advantages are that it is simple safe and does not cause leg weakness
If research shows that LIA provides adequate pain relief without weakness it may be a better option to use routinely rather than FNB The primary outcome measure is the amount of morphine used in the first 48 hours The secondary outcome measures are the Total Pain Relief Score TOTPAR post operative pain scores the ability to achieve set rehabilitation goals readiness for discharge and qualitative data on patient recovery and satisfaction
Over the years multiple different combinations of these techniques have been tried All have advantages and disadvantages Generally those which completely numb the leg after the operation often cause weakness which interferes with movement Although the patient will have no pain getting up and around with the physiotherapist is crucial and the weakness can delay recovery However excessive pain can also interfere with movement There is therefore a balance to be struck between pain and weakness and the choice of anaesthetic technique is key
Researchers previously conducted a study at the Royal Devon and Exeter Hospital which compared the effects of two techniques the use of diamorphine in a spinal injection and the injection of pain killer around a nerve supplying the leg femoral nerve block FNB Whilst the research showed that FNB gave better pain relief there are still concerns that it causes weakness which may interfere with movement A newer technique has evolved over recent years in which pain killer is injected directly around the knee during the operation This is known as local infiltration analgesia LIA and the potential advantages are that it is simple safe and does not cause leg weakness
If research shows that LIA provides adequate pain relief without weakness it may be a better option to use routinely rather than FNB The primary outcome measure is the amount of morphine used in the first 48 hours The secondary outcome measures are the Total Pain Relief Score TOTPAR post operative pain scores the ability to achieve set rehabilitation goals readiness for discharge and qualitative data on patient recovery and satisfaction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 139814 | OTHER | IRAS Number | None |