Ignite Creation Date:
2024-05-06 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03505645
Status:
UNKNOWN
Last Update Posted:
2019-03-05
First Post:
2018-04-04
Brief Title:
Surgical Techniques in Arthroplasty of the Knee STArK 1 Trial
Sponsor:
Chloe Scott
Organization:
Royal Infirmary of Edinburgh
Study Overview
Official Title:
Surgical Techniques in Arthroplasty of the Knee STArK 1 Trial Periarticular Infiltration Versus Intra-articular Injection for Postoperative Analgesia in Primary Total Knee Arthroplasty a Randomised Double Blind Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
NOT_YET_RECRUITING
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:
STArK1
Brief Summary:
Study Background Osteoarthritis of the knee is a common degenerative musculoskeletal condition which affects nearly five million people in the United Kingdom Some patients will require total knee replacement surgery if their symptoms of pain and disability are not controlled adequately by so-called conservative measures such as weight-loss activity modification and analgesic pain-killer medication
Over the past ten years our understanding of pain-relief strategies during total knee replacement often termed Enhanced Recovery principles has helped improve patient care and reduced length of hospital admission Enhanced Recovery principles recommend the use of analgesic medications which can be delivered in a variety of ways eg tablets and injections This is termed multi-modal analgesia
Prior to total knee replacement the patient will receive an injection around the nerves in the spine regional anaesthesia which numbs the patient from the waist down and allows the surgeon to perform the operation in a safe and pain-free manner During the operation surgeons often choose to deliver extra local anaesthetic to prolong the degree of pain-relief in the immediate post-operative period This can enable patients to mobilise early and is associated with greater long-term satisfaction
There are two main methods of delivering this extra form of pain-relief during the operation Peri-articular injection involves multiple injections of local anaesthetic into the soft-tissues surround the knee In contrast Intra-articular injection involves a single injection directly into the knee joint once the operation is finished Currently there is no clear evidence available to Orthopaedic surgeons to inform us which technique is better at providing pain relief for patients undergoing total knee replacement surgery
All patients undergoing total knee replacement surgery for osteoarthritis of the knee will be invited to participate in this study We intend to recruit a total of 120 patients During the patients total knee replacement surgery they shall receive an injection of local anaesthetic around the soft-tissues of the knee Peri-Articular Injection or directly into the knee joint itself Intra-Articular Injection The decision regarding which treatment they receive is decided entirely by randomisation
Following the operation a member of the research team will assess the patient on the ward to collect information regarding levels of pain and overall satisfaction The type of injection received shall be kept secret from both the patient and the member of the research team collecting the post-operative pain scores
After the patient has been safely discharged from hospital we intend to follow-up all participants for one year This will involve routine clinic appointments at six weeks and twelve months following surgery This will involve review and clinical examination by a member of the orthopaedic team who have treated the patient whilst in hospital andor a member of the research team
In addition all patients will be asked to complete a questionnaire at twelve months regarding their level of function and pain These questionnaires have been used widely in the medical literature and have a strong evidence base for their use
What is the aim of this study The aim of this study is compare the amount of pain relief provided by two different methods of local anaesthetic injection techniques used in total knee replacement surgery In addition we would like to know if this influences the patients immediate and long-term recovery after surgery
Over the past ten years our understanding of pain-relief strategies during total knee replacement often termed Enhanced Recovery principles has helped improve patient care and reduced length of hospital admission Enhanced Recovery principles recommend the use of analgesic medications which can be delivered in a variety of ways eg tablets and injections This is termed multi-modal analgesia
Prior to total knee replacement the patient will receive an injection around the nerves in the spine regional anaesthesia which numbs the patient from the waist down and allows the surgeon to perform the operation in a safe and pain-free manner During the operation surgeons often choose to deliver extra local anaesthetic to prolong the degree of pain-relief in the immediate post-operative period This can enable patients to mobilise early and is associated with greater long-term satisfaction
There are two main methods of delivering this extra form of pain-relief during the operation Peri-articular injection involves multiple injections of local anaesthetic into the soft-tissues surround the knee In contrast Intra-articular injection involves a single injection directly into the knee joint once the operation is finished Currently there is no clear evidence available to Orthopaedic surgeons to inform us which technique is better at providing pain relief for patients undergoing total knee replacement surgery
All patients undergoing total knee replacement surgery for osteoarthritis of the knee will be invited to participate in this study We intend to recruit a total of 120 patients During the patients total knee replacement surgery they shall receive an injection of local anaesthetic around the soft-tissues of the knee Peri-Articular Injection or directly into the knee joint itself Intra-Articular Injection The decision regarding which treatment they receive is decided entirely by randomisation
Following the operation a member of the research team will assess the patient on the ward to collect information regarding levels of pain and overall satisfaction The type of injection received shall be kept secret from both the patient and the member of the research team collecting the post-operative pain scores
After the patient has been safely discharged from hospital we intend to follow-up all participants for one year This will involve routine clinic appointments at six weeks and twelve months following surgery This will involve review and clinical examination by a member of the orthopaedic team who have treated the patient whilst in hospital andor a member of the research team
In addition all patients will be asked to complete a questionnaire at twelve months regarding their level of function and pain These questionnaires have been used widely in the medical literature and have a strong evidence base for their use
What is the aim of this study The aim of this study is compare the amount of pain relief provided by two different methods of local anaesthetic injection techniques used in total knee replacement surgery In addition we would like to know if this influences the patients immediate and long-term recovery after surgery
Detailed Description:
The aim of this study is compare the amount of post-operative pain relief provided by two different methods of local anaesthetic injection techniques used in total knee replacement surgery
Enhanced Recovery After Surgery protocols has significantly shortened recovery-time and length of hospital admission after total knee replacement TKR A major factor in this improvement has been the incorporation of multi- modal therapies which deliver adequate pain relief limit post-operative nausea and enable early mobilisation
Peripheral nerve blocks are performed by the anaesthetist immediately prior to surgery This involves injecting local anaesthetic around the nerves which supply sensation around the knee Injecting directly into the nerve can damage it and lead to significant disability For this reason peripheral nerve blocks are often performed under ultrasound guidance This can be time-consuming and does not negate the risk of nerve injury
Peri-articular infiltration is performed during the operation by the surgeon In the knee this involves injecting a solution of local anaesthetic into multiple specified soft-tissue and bony regions around the knee It is performed blind without ultrasound guidance and also carries risk of nerve injury
Intra-articular injections involve the surgeon injecting local anaesthetic solution into the knee joint itself During TKR this can be performed after closure of the joint capsule immediately prior to skin closure This avoids risks to nerves and arteries as it is placed into the large knee joint and not blindly around the joint capsule In addition it is simple to perform and less time-consuming than peri-articular infiltration
Randomised controlled trials have previously compared femoral peripheral nerve blocks to periarticular infiltration periarticular infiltration with and without posterior capsule infiltration and periarticular infiltration to the front versus the back of the knee However to our knowledge the technique of intra-articular injection has not been compared to peri- articular infiltration for immediate post-operative analgesia following total knee arthroplasty
Study Design A double-blind randomised controlled trial RCT will be conducted in a single hospital with four Consultant Knee Surgeons recruiting patients It is anticipated from a previous RCT performed at the same centre that recruitment be completed within 2 years
Participants All patients undergoing primary total knee replacement for osteoarthritis under the care of 4 Consultant Orthopaedic Surgeons at the Royal Infirmary of Edinburgh will be assessed for eligibility for study enrolment
All patients will receive trial information patient information sheet when they are placed on the waiting list for TKR Patients currently wait 12 weeks for surgery When patients are reviewed at a pre-assessment clinic 2-4 weeks prior surgery those who fulfil the inclusion criteria will have the trial explained in full by the research team supervised by the lead investigator Ms Chloe Scott and will decide whether they wish to be involved Informed consent will be obtained at this stage Patients will then have 2-4 weeks before surgery to opt out of the study if they wish
Power Calculation Audit of 10 TKR patients measuring VAS pain scores at 6 and 24 hours has demonstrated a standard deviation of 214 points The minimum clinically important difference MCID for this score is 12mm 12 points Assuming approximate normality for the VAS primary outcome data on 102 patients 51 in each arm will be required for 80 power at 5 significance Allowing for a dropout rate of 10 120 patients will be recruited
Randomization A total of 120 participants will be randomized in a 11 ratio to either Treatment Group 1 periarticular infiltration or Treatment Group 2 intraarticular injection using the sealed opaque envelope randomization technique This will be performed after spinal anaesthetic has been administered before surgery commences
Baseline information All patients will be initially evaluated with a complete history and physical examination For all patients entering the study the following baseline information will be recorded Age sex BMI Kellgren-Lawrence grade of osteoarthritis preoperative analgesia regime length of knee pain duration employment status and postcode Baseline VAS Pain scores Oxford Knee Scores and EQ-5D scores will be collected as is routine for all of our arthroplasty patients
Peri-operative Protocol All patients will be admitted on the day of surgery and undergo a standardised enhanced recovery anaesthetic protocol including spinal anaesthetic with no intrathecal diamorphine and no peripheral nerve blocks femoral sciatic or adductor canal
All patients will undergo a cemented Triathlon Stryker Mahwah NJ USA cruciate retaining TKR
All patients will be prescribed standardised post-operative analgesia including Oxycodone MR 15mg twice daily for 4 doses with stepdown to weaker opiate usually Cocodamol 30500 2 tabs 4 times per day Oxycodone IR 5-10mg prn for breakthrough pain
Patients will be placed first or second on the operating list to enable VAS pain scores to be collected at the assigned times
Multimodal injection The injection will consist of the same drugs for all patients 150mg levobupivacaine 025 10mg morphine and 30mg ketorolac made up to a volume of 150ml with saline
The difference between treatment groups is how the multimodal injection is administered either by periarticular infiltration around the knee or by simple intra-articular injection after the knee joint capsule has been closed
Treatment group 1 Periarticular infiltration
Intra-operatively after bone cuts have been made and prior to implant cementation the multimodal injection will be infiltrated around the knee at 6 specific sites
1 Medial femoral condyle periosteum
2 Medial gutter
3 Lateral femoral condyle periosteum
4 Lateral gutter
5 Posteromedial capsule
6 Posterolateral capsule
Treatment Group 2 Intra-articular infiltration After implant cementation and watertight joint capsular closure the multimodal injection will be injected intra-articularly through the closed capsule
Post-operative protocol and Follow-up Postoperatively patients will complete a VAS pain score at 6 12 24 and 48 hours postoperatively with research staff blinded to the infiltration technique employed All analgesia required in the first 24 hours will be recorded and an opiate equivalency dose calculator used to determine opiate intake Joint Formulary Committee 2016 At 48 hours in addition to recording a VAS pain score patients will be asked how satisfied they were with their pain relief as scored on a 5 point Likert score from very satisfied to very dissatisfied
Patients will then undergo routine postoperative management with review by arthroplasty practitioners blinded to their treatment arm at 6 weeks where they will be examined and will be asked to complete an adverse events questionnaire
Patient reported outcomes including Oxford Knee Scores and EQ-5D scores will be collected as standard at 12 months
Enhanced Recovery After Surgery protocols has significantly shortened recovery-time and length of hospital admission after total knee replacement TKR A major factor in this improvement has been the incorporation of multi- modal therapies which deliver adequate pain relief limit post-operative nausea and enable early mobilisation
Peripheral nerve blocks are performed by the anaesthetist immediately prior to surgery This involves injecting local anaesthetic around the nerves which supply sensation around the knee Injecting directly into the nerve can damage it and lead to significant disability For this reason peripheral nerve blocks are often performed under ultrasound guidance This can be time-consuming and does not negate the risk of nerve injury
Peri-articular infiltration is performed during the operation by the surgeon In the knee this involves injecting a solution of local anaesthetic into multiple specified soft-tissue and bony regions around the knee It is performed blind without ultrasound guidance and also carries risk of nerve injury
Intra-articular injections involve the surgeon injecting local anaesthetic solution into the knee joint itself During TKR this can be performed after closure of the joint capsule immediately prior to skin closure This avoids risks to nerves and arteries as it is placed into the large knee joint and not blindly around the joint capsule In addition it is simple to perform and less time-consuming than peri-articular infiltration
Randomised controlled trials have previously compared femoral peripheral nerve blocks to periarticular infiltration periarticular infiltration with and without posterior capsule infiltration and periarticular infiltration to the front versus the back of the knee However to our knowledge the technique of intra-articular injection has not been compared to peri- articular infiltration for immediate post-operative analgesia following total knee arthroplasty
Study Design A double-blind randomised controlled trial RCT will be conducted in a single hospital with four Consultant Knee Surgeons recruiting patients It is anticipated from a previous RCT performed at the same centre that recruitment be completed within 2 years
Participants All patients undergoing primary total knee replacement for osteoarthritis under the care of 4 Consultant Orthopaedic Surgeons at the Royal Infirmary of Edinburgh will be assessed for eligibility for study enrolment
All patients will receive trial information patient information sheet when they are placed on the waiting list for TKR Patients currently wait 12 weeks for surgery When patients are reviewed at a pre-assessment clinic 2-4 weeks prior surgery those who fulfil the inclusion criteria will have the trial explained in full by the research team supervised by the lead investigator Ms Chloe Scott and will decide whether they wish to be involved Informed consent will be obtained at this stage Patients will then have 2-4 weeks before surgery to opt out of the study if they wish
Power Calculation Audit of 10 TKR patients measuring VAS pain scores at 6 and 24 hours has demonstrated a standard deviation of 214 points The minimum clinically important difference MCID for this score is 12mm 12 points Assuming approximate normality for the VAS primary outcome data on 102 patients 51 in each arm will be required for 80 power at 5 significance Allowing for a dropout rate of 10 120 patients will be recruited
Randomization A total of 120 participants will be randomized in a 11 ratio to either Treatment Group 1 periarticular infiltration or Treatment Group 2 intraarticular injection using the sealed opaque envelope randomization technique This will be performed after spinal anaesthetic has been administered before surgery commences
Baseline information All patients will be initially evaluated with a complete history and physical examination For all patients entering the study the following baseline information will be recorded Age sex BMI Kellgren-Lawrence grade of osteoarthritis preoperative analgesia regime length of knee pain duration employment status and postcode Baseline VAS Pain scores Oxford Knee Scores and EQ-5D scores will be collected as is routine for all of our arthroplasty patients
Peri-operative Protocol All patients will be admitted on the day of surgery and undergo a standardised enhanced recovery anaesthetic protocol including spinal anaesthetic with no intrathecal diamorphine and no peripheral nerve blocks femoral sciatic or adductor canal
All patients will undergo a cemented Triathlon Stryker Mahwah NJ USA cruciate retaining TKR
All patients will be prescribed standardised post-operative analgesia including Oxycodone MR 15mg twice daily for 4 doses with stepdown to weaker opiate usually Cocodamol 30500 2 tabs 4 times per day Oxycodone IR 5-10mg prn for breakthrough pain
Patients will be placed first or second on the operating list to enable VAS pain scores to be collected at the assigned times
Multimodal injection The injection will consist of the same drugs for all patients 150mg levobupivacaine 025 10mg morphine and 30mg ketorolac made up to a volume of 150ml with saline
The difference between treatment groups is how the multimodal injection is administered either by periarticular infiltration around the knee or by simple intra-articular injection after the knee joint capsule has been closed
Treatment group 1 Periarticular infiltration
Intra-operatively after bone cuts have been made and prior to implant cementation the multimodal injection will be infiltrated around the knee at 6 specific sites
1 Medial femoral condyle periosteum
2 Medial gutter
3 Lateral femoral condyle periosteum
4 Lateral gutter
5 Posteromedial capsule
6 Posterolateral capsule
Treatment Group 2 Intra-articular infiltration After implant cementation and watertight joint capsular closure the multimodal injection will be injected intra-articularly through the closed capsule
Post-operative protocol and Follow-up Postoperatively patients will complete a VAS pain score at 6 12 24 and 48 hours postoperatively with research staff blinded to the infiltration technique employed All analgesia required in the first 24 hours will be recorded and an opiate equivalency dose calculator used to determine opiate intake Joint Formulary Committee 2016 At 48 hours in addition to recording a VAS pain score patients will be asked how satisfied they were with their pain relief as scored on a 5 point Likert score from very satisfied to very dissatisfied
Patients will then undergo routine postoperative management with review by arthroplasty practitioners blinded to their treatment arm at 6 weeks where they will be examined and will be asked to complete an adverse events questionnaire
Patient reported outcomes including Oxford Knee Scores and EQ-5D scores will be collected as standard at 12 months
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?:
False
Is an FDA AA801 Violation?:
None