Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419153
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-04
Brief Title:
Evaluating the Efficacy of the Sub-psoas Fascial Plane Block for Post-operative Analgesia Following Hemiarthroplasty
Sponsor:
University College Hospital Galway
Organization:
University College Hospital Galway
Study Overview
Official Title:
Evaluating the Efficacy of the Sub-psoas Fascial Plane Block for Post-operative Analgesia Following Hemiarthroplasty
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The study aims to examine the efficacy and safety of an ultrasound-guided regional anaesthetic technique intended to provide pain relief following hip surgery It involves targeting a layer of tissue known as the psoas fascia where the nerves of the lumbar plexus supplying the lower limb are located There are many well-established ultrasound-guided techniques that target similar anatomical planes and structures such as the psoas compartment block and quadratus lumborum plane block which are widely used in clinical practice This is not a new technique but rather a new approach to a well-established and utilized technique the psoas compartment block Early remobilisation plays a key role in the recovery of post-operative patients helping to reduce the incidence of pneumonia deep vein thrombosis and delirium By reducing motor weakness while still providing adequate pain relief and minimizing the use of strong painkillers such as morphine it will help to reduce the risk of falls and length of hospital stay An initial case series in GUH has previously followed a small cohort of patients who following informed consent underwent the subpsoas fascia plane SPF block vs suprainguinal fascia iliaca block as part of their multimodal pain relief following surgery It was found that in this group there was a reduction in postoperative pain scores decreased use of strong painkillers and earlier time to remobilisation
Detailed Description:
Background
Hip fracture surgery is one of the commonest orthopaedic operations performed in the Republic of Ireland and is associated with significant patient morbidity mortality and health care costs The National Irish Hip Fracture Report recorded 1950 hip fractures in 2013 71 were female and the highest proportions were in the 80-89 age group It has been estimated that the overall prevalence of hip fractures is projected to increase in line with increasing elderly population and projected demographic changes
Early remobilization has become a key integral component of the optimal post-surgical management of hip fractures Based on the National Institute for Health and Care Excellence NICE guidance the National Hip Fracture UK Database has adopted patient remobilisation on the day of or day after surgery as a key performance indicator Early mobilisation has been shown to reduce the risk of in-hospital mortality following hip fracture and to increase the likelihood of discharge from hospital In 2018 20 of patients failed to achieve the early remobilisation target due to pain andor hypotension factors which might have been anticipated by clear perioperative protocols and closer working between surgery and anaesthetic colleagues
Current AAGBI guidelines describe core principles of the peri-operative management of people with hip fracture with one of their aims recommending a peripheral nerve block immediately prior to operative fixation of a hip fracture in the Emergency Department and at the time of surgery provided six hours have passed between blocks There are two peripheral nerve blocks commonly used in the perioperative setting of hip fracture repair namely femoral or fascia iliaca block Both techniques have been proven to be safe and efficacious however these peripheral nerve blocks have been associated with some residual muscle weakness and increased falls risk which further hampens the ability of a patient to remobilize post-operatively There is a clinical need to establish a safe reliable regional anaesthetic technique that will still offer long-acting opioid sparing analgesia yet minimise the associated motor blockade in order to improve and facilitate remobilization By also potentially interrupting the sympathetically mediated pain in the lower limb following hip surgery through the blockade of this lumbar sympathetic plexus it may provide an avenue to produce significant analgesia without causing somatic sensory deficits eg residual motor weakness thereby facilitating early remobilisation and enhanced recovery This is not a new technique rather it is a new approach to a very well established and utilized technique the psoas compartment block which has been shown to be very effective this approach is expected to be as efficacious and potentially safer than previous approaches as it avoids the nerve roots In terms of the side effect profile of this novel approach to the PCB - there are no new expected side effects above the standard previously explained effects that can occur with any regional technique for example haematoma LAST Neuropraxia This approach would theoretically be associated with a lower side effect profile than previous landmark or current ultrasound-guided PCB technique as it avoids the risk profile of traversing the psoas muscle body and near the exit of the lumbar plexus nerve roots
This study aims to follow up on the inital case series discussed above to evaluate the efficacy of the SPF block for post op analgesia in patients undergoing hemiarthroplasty surgery
Aims and Objectives
This will be a randomised control trial The primary aim of this study is to further evaluate the efficacy of a sub-psoas muscle fascial plane regional block for providing adequate opioid-sparingreducing post-operative analgesia in comparrisson to patients who do not receive a regional anaesthesia block and standard analgesic regieme
The secondary aim of this study is to explore patients experience post-operatively in terms of their pain time to remobilisation total analgesic requirements and quality of recovery
Study End PointsPrimary Objectives
To evaluate the post-operative analgesia provided by the proposed regional anaesthesia block utilising
Quality of Recovery 15 QoR15 Score
Pain scores Numerical rating scales Pain Map VAS NRS
Intraoperative and Postoperative Opioid Requirements Quantification
Time to remobilisation post-operatively
see supplementary material
Study Design
This trial will take place in the Anaesthetic and Orthopaedic Departments University Hospital Galway All participants will be treated with either the sub-psoas fascial plane block pre or post-operatively or no regional anaesethesia with a standard analgesic regieme written consent will be obtained from each participant Where informed consent is attained a clinical note review will take place in addition to the psoas muscle sympathetic chain block pre-operatively Patients will be closely monitored throughout the procedure and surgery They will be followed up in the post-anaesthetic care recovery unit to assess their pain in addition to on day one and two on the ward where a full assessment of their recovery pain opioid requirements and overall post-operative course will be carried out by the anaesthetic team member involved in this study
Study Methodology
In this RCT all patients enrolled will be undergoing either emergency hip surgery under the orthopaedic team in the theatre complex in University Hospital Galway Ethical approval from the Galway Clinical Research Ethics Committee will be sought Once approved the procedure will be explained at length by the primary research or co-investigators to the patient and all questions will be addressed The aim would be to provide a timeframe for the patient to consider the procedure before providing consent ie during pre-operative assessment on the ward the night before or morning of their surgery and undergoing the consent process when in the theatre complex If the patient is agreeable verbal informed consent will be obtained a clinical note review will take place to attain basic demographic and clinical data including diagnosis indication for surgery type of surgery type of anaesthetic technique comorbidities preadmission opioid requirements The procedure will be explained at length to the patient and if agreeable to proceed the patient will be monitored closely as normally would occur in the theatre setting they will be positioned in theatre briefly onto their lateral side Under ultrasound-guidance the regional nerve block will be performed by the experienced consultant anaesthesiologist whereby 30ml of 075 Ropivicaine will be slowly injected into the subpsoas fascial plane whilst at all times throughout and following the procedures the patient will be closely haemodynamically monitored The patient will be followed up in the recovery post-anaesthetic care unit up to four hours following their surgery They will then be reviewed by the one of the co-investigators at a timeframe of 0-24 hours and 24-48 hours post-operatively to further establish their analgesic efficacy their pain scores see supplementary appendix quality of recovery time to remobilization and opioids requirements ensuring the patient is comfortable and aiming to maximize their recovery period
This is not a new technique rather it is a new approach to a very well established and utilized technique - the psoas compartment block PCB The PCB utilizes a posterior approach whereby it traverses through the body of the psoas muscle thereby carrying the small risk profile of being near the plane of where the lumbar plexus roots exit the body of the muscle
Hip fracture surgery is one of the commonest orthopaedic operations performed in the Republic of Ireland and is associated with significant patient morbidity mortality and health care costs The National Irish Hip Fracture Report recorded 1950 hip fractures in 2013 71 were female and the highest proportions were in the 80-89 age group It has been estimated that the overall prevalence of hip fractures is projected to increase in line with increasing elderly population and projected demographic changes
Early remobilization has become a key integral component of the optimal post-surgical management of hip fractures Based on the National Institute for Health and Care Excellence NICE guidance the National Hip Fracture UK Database has adopted patient remobilisation on the day of or day after surgery as a key performance indicator Early mobilisation has been shown to reduce the risk of in-hospital mortality following hip fracture and to increase the likelihood of discharge from hospital In 2018 20 of patients failed to achieve the early remobilisation target due to pain andor hypotension factors which might have been anticipated by clear perioperative protocols and closer working between surgery and anaesthetic colleagues
Current AAGBI guidelines describe core principles of the peri-operative management of people with hip fracture with one of their aims recommending a peripheral nerve block immediately prior to operative fixation of a hip fracture in the Emergency Department and at the time of surgery provided six hours have passed between blocks There are two peripheral nerve blocks commonly used in the perioperative setting of hip fracture repair namely femoral or fascia iliaca block Both techniques have been proven to be safe and efficacious however these peripheral nerve blocks have been associated with some residual muscle weakness and increased falls risk which further hampens the ability of a patient to remobilize post-operatively There is a clinical need to establish a safe reliable regional anaesthetic technique that will still offer long-acting opioid sparing analgesia yet minimise the associated motor blockade in order to improve and facilitate remobilization By also potentially interrupting the sympathetically mediated pain in the lower limb following hip surgery through the blockade of this lumbar sympathetic plexus it may provide an avenue to produce significant analgesia without causing somatic sensory deficits eg residual motor weakness thereby facilitating early remobilisation and enhanced recovery This is not a new technique rather it is a new approach to a very well established and utilized technique the psoas compartment block which has been shown to be very effective this approach is expected to be as efficacious and potentially safer than previous approaches as it avoids the nerve roots In terms of the side effect profile of this novel approach to the PCB - there are no new expected side effects above the standard previously explained effects that can occur with any regional technique for example haematoma LAST Neuropraxia This approach would theoretically be associated with a lower side effect profile than previous landmark or current ultrasound-guided PCB technique as it avoids the risk profile of traversing the psoas muscle body and near the exit of the lumbar plexus nerve roots
This study aims to follow up on the inital case series discussed above to evaluate the efficacy of the SPF block for post op analgesia in patients undergoing hemiarthroplasty surgery
Aims and Objectives
This will be a randomised control trial The primary aim of this study is to further evaluate the efficacy of a sub-psoas muscle fascial plane regional block for providing adequate opioid-sparingreducing post-operative analgesia in comparrisson to patients who do not receive a regional anaesthesia block and standard analgesic regieme
The secondary aim of this study is to explore patients experience post-operatively in terms of their pain time to remobilisation total analgesic requirements and quality of recovery
Study End PointsPrimary Objectives
To evaluate the post-operative analgesia provided by the proposed regional anaesthesia block utilising
Quality of Recovery 15 QoR15 Score
Pain scores Numerical rating scales Pain Map VAS NRS
Intraoperative and Postoperative Opioid Requirements Quantification
Time to remobilisation post-operatively
see supplementary material
Study Design
This trial will take place in the Anaesthetic and Orthopaedic Departments University Hospital Galway All participants will be treated with either the sub-psoas fascial plane block pre or post-operatively or no regional anaesethesia with a standard analgesic regieme written consent will be obtained from each participant Where informed consent is attained a clinical note review will take place in addition to the psoas muscle sympathetic chain block pre-operatively Patients will be closely monitored throughout the procedure and surgery They will be followed up in the post-anaesthetic care recovery unit to assess their pain in addition to on day one and two on the ward where a full assessment of their recovery pain opioid requirements and overall post-operative course will be carried out by the anaesthetic team member involved in this study
Study Methodology
In this RCT all patients enrolled will be undergoing either emergency hip surgery under the orthopaedic team in the theatre complex in University Hospital Galway Ethical approval from the Galway Clinical Research Ethics Committee will be sought Once approved the procedure will be explained at length by the primary research or co-investigators to the patient and all questions will be addressed The aim would be to provide a timeframe for the patient to consider the procedure before providing consent ie during pre-operative assessment on the ward the night before or morning of their surgery and undergoing the consent process when in the theatre complex If the patient is agreeable verbal informed consent will be obtained a clinical note review will take place to attain basic demographic and clinical data including diagnosis indication for surgery type of surgery type of anaesthetic technique comorbidities preadmission opioid requirements The procedure will be explained at length to the patient and if agreeable to proceed the patient will be monitored closely as normally would occur in the theatre setting they will be positioned in theatre briefly onto their lateral side Under ultrasound-guidance the regional nerve block will be performed by the experienced consultant anaesthesiologist whereby 30ml of 075 Ropivicaine will be slowly injected into the subpsoas fascial plane whilst at all times throughout and following the procedures the patient will be closely haemodynamically monitored The patient will be followed up in the recovery post-anaesthetic care unit up to four hours following their surgery They will then be reviewed by the one of the co-investigators at a timeframe of 0-24 hours and 24-48 hours post-operatively to further establish their analgesic efficacy their pain scores see supplementary appendix quality of recovery time to remobilization and opioids requirements ensuring the patient is comfortable and aiming to maximize their recovery period
This is not a new technique rather it is a new approach to a very well established and utilized technique - the psoas compartment block PCB The PCB utilizes a posterior approach whereby it traverses through the body of the psoas muscle thereby carrying the small risk profile of being near the plane of where the lumbar plexus roots exit the body of the muscle
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None