Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04635176
Status:
RECRUITING
Last Update Posted:
2023-05-10
First Post:
2020-10-23
Brief Title:
Comparing Local Anesthesia With and Without iPACK Block
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Infiltration Between the Popliteal Artery and the Capsule of the Knee iPACK With Local Infiltration of Analgesia LIA and Adductor Canal Block ACB Improves Postoperative Pain in Total Knee Arthroplasty A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-05
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:
Total knee arthroplasty is an effective surgical intervention for patients with chronic osteoarthritis commonly performed worldwide Postoperative pain management has been a key focus in patient care for this procedure Poorly controlled pain following total knee arthroplasty is associated with decreased ambulation increased length of hospital stay increased complications particularly related to significant opioid use and overall suboptimal patient recovery Appropriate postoperative pain management utilizing motor sparing peripheral nerve blocks and periarticular injections has been shown to provide faster more optimized patient recovery and reduced hospital length of stay in patients undergoing total knee arthroplasty
Adductor canal block ACB is a well-studied peripheral nerve block performed for analgesia following total knee arthroplasty ACB is an effective component of multimodal analgesia providing improved pain control to the peripatellar and intra-articular aspect of the knee joint while largely preserving the strength of the quadriceps muscles1 In addition perioperative local infiltration analgesia LIA performed by the orthopaedic surgical team is a common practice that has been shown to improve short-term postoperative pain relief and reduce total systemic opioid consumption during hospital stay2 for total knee arthroplasty
The Infiltration between the Popliteal Artery and Capsule of the Knee iPACK block is a newly described regional anesthesia technique for postoperative analgesia in total knee arthroplasty performed under ultrasound guidance It targets the articular branches of the tibial common peroneal and obturator nerves in the popliteal region and aims to provide analgesia to the posterior aspect of the knee joint without compromising lower extremity motor function following total knee arthroplasty
This study aims to determine whether the IPACK block provides additional analgesia in combination with ACB LIA for total knee arthroplasty surgeries The study will examine how much additional analgesia IPACK provides in the context of an already-optimized regional anesthesia pathway for total knee arthroplasty which uses ACB LIA both modalities that have reasonable existing evidence
Adductor canal block ACB is a well-studied peripheral nerve block performed for analgesia following total knee arthroplasty ACB is an effective component of multimodal analgesia providing improved pain control to the peripatellar and intra-articular aspect of the knee joint while largely preserving the strength of the quadriceps muscles1 In addition perioperative local infiltration analgesia LIA performed by the orthopaedic surgical team is a common practice that has been shown to improve short-term postoperative pain relief and reduce total systemic opioid consumption during hospital stay2 for total knee arthroplasty
The Infiltration between the Popliteal Artery and Capsule of the Knee iPACK block is a newly described regional anesthesia technique for postoperative analgesia in total knee arthroplasty performed under ultrasound guidance It targets the articular branches of the tibial common peroneal and obturator nerves in the popliteal region and aims to provide analgesia to the posterior aspect of the knee joint without compromising lower extremity motor function following total knee arthroplasty
This study aims to determine whether the IPACK block provides additional analgesia in combination with ACB LIA for total knee arthroplasty surgeries The study will examine how much additional analgesia IPACK provides in the context of an already-optimized regional anesthesia pathway for total knee arthroplasty which uses ACB LIA both modalities that have reasonable existing evidence
Detailed Description:
Currently limited studies exist in the literature regarding the use of iPACK for analgesia in total knee arthroplasty Specific studies on the addition of iPACK to ACB or LIA demonstrate clinically significant reductions in pain scores for patients undergoing total knee arthroplasty However no studies currently examine the use of iPACK in the setting of patients receiving both ACB and LIA as a fully optimized regional anesthesia bundle for postoperative analgesia in total knee arthroplasty As such this study aims to determine whether the addition of the iPACK block in combination with ACB and LIA will improve analgesia compared to what is provided by ACB and LIA alone
Rationale for study
The IPACK block based on limited existing literature seems to provide superior analgesia with minimal complications following total knee arthroplasty
This study aims to determine whether the IPACK block provides additional analgesia in combination with ACB LIA for total knee arthroplasty surgeries The study will examine how much additional analgesia IPACK provides in the context of an already-optimized regional anesthesia pathway for total knee arthroplasty which uses ACB LIA both modalities that have reasonable existing evidence
Determining the effectiveness of IPACK in addition to the already validated multimodal analgesia including ACB and LIA for improving postoperative pain may further improve clinical outcomes in patients undergoing total knee arthroplasty This may reduce postoperative opioid requirements and its side effects increase patient satisfaction and decrease morbidity and mortality associated with a prolonged hospital stay
The demand for total knee arthroplasty is predicted to increase in the upcoming years owing to an aging population and increased prevalence of osteoarthritis worldwide The growing number generates multiple issues to the healthcare system mainly the additional pressure to decrease the already unsustainable high healthcare costs The role of iPACK as an additional component of pain management may be the key to providing a safe and cost-effective healthcare service to patients undergoing total knee arthroplasty
Study Question Does the addition of the iPACK block in combination with ACB and LIA improve postoperative analgesia and clinical outcomes compared to ACB and LIA alone in patients undergoing total knee arthroplasty
Hypothesis
Investigators hypothesize that the addition of this newly described motor-sparing iPACK block will significantly improve analgesia and clinical outcomes in patients undergoing total knee arthroplasty
Study Design
To determine the effectiveness of the iPACK block as a component of multimodal analgesia for patients undergoing total knee arthroplasty this study will be a prospective double blinded randomized controlled trial where the patients will be randomized to 2 groups
Group A will receive perioperative ACB LIA and sham IPACK block Group B will receive perioperative ACB LIA and real IPACK block
In addition all patients will receive a standard spinal anesthetic as per our institutional protocol along with procedural IV sedation at the discretion of the attending anesthesiologist Local infiltration analgesia will be administered by the orthopaedic surgeon as per standard practice ACB and iPACK block will be performed by the anesthesiologist immediately preoperatively under ultrasound guidance as follows
All patients in the study will receive ACB performed by an experienced anesthesiologist as conventionally described using full aseptic technique in-plane ultrasound guidance identification of the superficial femoral artery sartorius muscle and adductor canal Local anesthetic 025 bupivacaine 25mcgmL epinephrine 50mcgmL preservative-free dexamethasone x 15mL will be infiltrated with real-time ultrasound visualization needle approach lateral to medial with incremental injection intermittent aspiration and confirmation of adequate local anesthetic spread
Patients in group A will receive a sham iPACK block while those in group B will receive a real iPACK block Both sham and real iPACK blocks will be performed by an experienced anesthesiologist blinded to the intervention Real and sham iPACK blocks will be performed as conventionally described with ultrasound guidance initial approach 1 finger breadth above the patella if this approach fails subsequent attempt at level of femoral condylesbicondylar approach All sham and real iPACK blocks will be done with full aseptic technique in-plane ultrasound guidance identification of popliteal arteryvessels femur and sciatic nerve Normal saline x 20mL Group A or local anesthetic x 20mL Group B - 025 bupivacaine 25mcgmL epinephrine 50mcgmL preservative-free dexamethasone will be infiltrated with real-time ultrasound visualization needle approach medial to lateral with incremental injection intermittent aspiration and confirmation of adequate local anesthetic spread
The study personnel including research team anesthesiologists surgeons physiotherapists recovery room and ward nurses as well as patients will be blinded to the group allocation Anesthesia assistants not involved in study data collection or patient care will prepare the sham or real local anesthetic injectate solution for iPACK block Syringes will be prepared immediately after randomization and before block placement and provided to the blinded anesthesiologist Pain scores and opioid consumption length of stay and other data will be collected and assessed in person by a member of the research team or patient care team who is blinded to study interventions
Study procedure
Participating orthopaedic surgeons will identify eligible patients and introduce them to the study and research team at Alberta Hip and Knee Clinic AHKC Research staff will follow recruitment procedure and seek informed consent from patients at AHKC Participation in this study will remain completely voluntary without any pressure from investigators Patients questions will be answered at recruitment session Upon recruitment patients will be asked to complete Western Ontario and McMaster Universities Arthritis Index WOMAC and Knee Society Scoring KSS
Study participants will be assigned study identification and get randomized in to two treatment arms
The statistician who run randomization would only know study identifications and stay blinded to patients treatment arms Hospital data will be used to know Length of Stay LOS and opioid consumption at hospital A physiotherapist will perform Timed Up and Go test and Range of Motion ROM Pre and post-operatively at Peter Lougheed Hospital Pain score will be recorded using Visual analogue scale 4 hours postoperatively and at discharge Emergency room visit or 30-day readmission will be accessed through Alberta Bone and Joint Health Institute ABJHI data repository Unanticipated complications of iPACK block and technical difficulties with performing the iPACK block will be recorded by the study anesthesiologist
Rationale for study
The IPACK block based on limited existing literature seems to provide superior analgesia with minimal complications following total knee arthroplasty
This study aims to determine whether the IPACK block provides additional analgesia in combination with ACB LIA for total knee arthroplasty surgeries The study will examine how much additional analgesia IPACK provides in the context of an already-optimized regional anesthesia pathway for total knee arthroplasty which uses ACB LIA both modalities that have reasonable existing evidence
Determining the effectiveness of IPACK in addition to the already validated multimodal analgesia including ACB and LIA for improving postoperative pain may further improve clinical outcomes in patients undergoing total knee arthroplasty This may reduce postoperative opioid requirements and its side effects increase patient satisfaction and decrease morbidity and mortality associated with a prolonged hospital stay
The demand for total knee arthroplasty is predicted to increase in the upcoming years owing to an aging population and increased prevalence of osteoarthritis worldwide The growing number generates multiple issues to the healthcare system mainly the additional pressure to decrease the already unsustainable high healthcare costs The role of iPACK as an additional component of pain management may be the key to providing a safe and cost-effective healthcare service to patients undergoing total knee arthroplasty
Study Question Does the addition of the iPACK block in combination with ACB and LIA improve postoperative analgesia and clinical outcomes compared to ACB and LIA alone in patients undergoing total knee arthroplasty
Hypothesis
Investigators hypothesize that the addition of this newly described motor-sparing iPACK block will significantly improve analgesia and clinical outcomes in patients undergoing total knee arthroplasty
Study Design
To determine the effectiveness of the iPACK block as a component of multimodal analgesia for patients undergoing total knee arthroplasty this study will be a prospective double blinded randomized controlled trial where the patients will be randomized to 2 groups
Group A will receive perioperative ACB LIA and sham IPACK block Group B will receive perioperative ACB LIA and real IPACK block
In addition all patients will receive a standard spinal anesthetic as per our institutional protocol along with procedural IV sedation at the discretion of the attending anesthesiologist Local infiltration analgesia will be administered by the orthopaedic surgeon as per standard practice ACB and iPACK block will be performed by the anesthesiologist immediately preoperatively under ultrasound guidance as follows
All patients in the study will receive ACB performed by an experienced anesthesiologist as conventionally described using full aseptic technique in-plane ultrasound guidance identification of the superficial femoral artery sartorius muscle and adductor canal Local anesthetic 025 bupivacaine 25mcgmL epinephrine 50mcgmL preservative-free dexamethasone x 15mL will be infiltrated with real-time ultrasound visualization needle approach lateral to medial with incremental injection intermittent aspiration and confirmation of adequate local anesthetic spread
Patients in group A will receive a sham iPACK block while those in group B will receive a real iPACK block Both sham and real iPACK blocks will be performed by an experienced anesthesiologist blinded to the intervention Real and sham iPACK blocks will be performed as conventionally described with ultrasound guidance initial approach 1 finger breadth above the patella if this approach fails subsequent attempt at level of femoral condylesbicondylar approach All sham and real iPACK blocks will be done with full aseptic technique in-plane ultrasound guidance identification of popliteal arteryvessels femur and sciatic nerve Normal saline x 20mL Group A or local anesthetic x 20mL Group B - 025 bupivacaine 25mcgmL epinephrine 50mcgmL preservative-free dexamethasone will be infiltrated with real-time ultrasound visualization needle approach medial to lateral with incremental injection intermittent aspiration and confirmation of adequate local anesthetic spread
The study personnel including research team anesthesiologists surgeons physiotherapists recovery room and ward nurses as well as patients will be blinded to the group allocation Anesthesia assistants not involved in study data collection or patient care will prepare the sham or real local anesthetic injectate solution for iPACK block Syringes will be prepared immediately after randomization and before block placement and provided to the blinded anesthesiologist Pain scores and opioid consumption length of stay and other data will be collected and assessed in person by a member of the research team or patient care team who is blinded to study interventions
Study procedure
Participating orthopaedic surgeons will identify eligible patients and introduce them to the study and research team at Alberta Hip and Knee Clinic AHKC Research staff will follow recruitment procedure and seek informed consent from patients at AHKC Participation in this study will remain completely voluntary without any pressure from investigators Patients questions will be answered at recruitment session Upon recruitment patients will be asked to complete Western Ontario and McMaster Universities Arthritis Index WOMAC and Knee Society Scoring KSS
Study participants will be assigned study identification and get randomized in to two treatment arms
The statistician who run randomization would only know study identifications and stay blinded to patients treatment arms Hospital data will be used to know Length of Stay LOS and opioid consumption at hospital A physiotherapist will perform Timed Up and Go test and Range of Motion ROM Pre and post-operatively at Peter Lougheed Hospital Pain score will be recorded using Visual analogue scale 4 hours postoperatively and at discharge Emergency room visit or 30-day readmission will be accessed through Alberta Bone and Joint Health Institute ABJHI data repository Unanticipated complications of iPACK block and technical difficulties with performing the iPACK block will be recorded by the study anesthesiologist
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