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
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Comparing pain scores using the visual analogue scale between 2 groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
The statistician who run randomization would only know study IDs and stay blinded to patients' treatment arms.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective unilateral TKA
- •Planned for regional anesthesia for the procedure
- •Age >=18
排除标准
- •Contraindications to regional anesthesia or peripheral nerve blocks
- •Allergy to local anesthetics or any of the study medications
- •Severe hepatic or renal insufficiency
- •Chronic opioid consumption
- •Patient with difficulty comprehending visual analogue scale pain scores
- •Pre-existing lower extremity neurologic abnormalities
- •Patients classified as American Society of Anesthesiologists score 3 or 4
- •Language/communication barrier
研究组 & 干预措施
Sham iPACK block
This groups will receive the adductor canal block with the local anesthetic (15 mL of 0.25% bupivacaine + 2.5 mcg/mL epinephrine + 50 mcg/mL preservative-free dexamethasone) and local infiltration of analgesia+ sham iPACK block with 20 mL of normal saline.
干预措施: Sham iPACK block with 20ml normal saline (Drug)
Real IPACK block.
This groups will receive the adductor canal block with the local anesthetic (15 mL of 0.25% bupivacaine + 2.5 mcg/mL epinephrine + 50 mcg/mL preservative-free dexamethasone) and local infiltration of analgesia + real iPACK block with 20 mL of 0.25% bupivacaine, 2.5mcg/mL epinephrine, and 50mcg/mL preservative-free dexamethasone
干预措施: Real iPACK block (20 mL of 0.25% bupivacaine, 2.5mcg/mL epinephrine, and 50mcg/mL preservative-free dexamethasone) (Drug)
结局指标
主要结局
Comparing pain scores using the visual analogue scale between 2 groups
时间窗: 24 hours after surgery
Visual analogue scale is a tool to measure intensity of pain in human. It is numeric (0-100);A higher score indicates greater pain intensity.
Comparing total opioid consumption between 2 groups
时间窗: During 24 hours after surgery
Opioid consumption will be compared between two groups by measuring how many milligrams opioids patients consume in each group, the total dose of opioids consumed by patients will be converted to oral morphine dose equivalents in milligrams, and this mg value will be compared between the groups. The opioid can refer to morphine or oxycodone or hydromorphone or codeine any kind of opioid-type medication. There is a standard conversion of any other opioid potency to "morphine equivalents" (eg: hydromorphone is 5x more potent than morphine).
Comparing total length of hospital stay
时间窗: 20-48 hours after surgery
Comparing total length of hospital stay
Timed Up and Go test results
时间窗: Up to 24 hours after surgery
Timed Up and Go test results
Comparing knee Range of Motion (ROM)
时间窗: Up to 24 hours after surgery
Comparing knee Range of Motion (ROM)
Comparing patient satisfaction using Western Ontario and McMaster Universities Arthritis Index (WOMAC)
时间窗: Up to 24 hours after surgery
The WOMAC is a patient reported outcome questionnaire, consisting 24 items divided into three subscales: 1) Pain (5 items), 2) Stiffness (2 items) and 3) Physical Function (17 items). A total WOMAC score is created by summing the items for all three subscales. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. Previous assessment has supported the internal consistency of the WOMAC subscale.
Comparing patient satisfaction using Knee Society Scoring (KSS)
时间窗: Up to 24 hours after surgery
The Knee Society Scoring system is both physician and patient-derived. It includes versions to be administered pre-operatively and post-operatively. It has an initial assessment of demographic details, including an expanded Charnley Functional classification. The objective knee score, completed by surgeon, includes a Visual Analogue Scale score of pain walking on level ground and on stairs or inclines, as well as an assessment of alignment, ligament stability, and Range Of Motion. The KSS System is a validated instrument based on surgeon and patient generated data, adapted to the diverse lifestyles and activities. The greater score associated with higher satisfaction.
次要结局
- Incidence of other unanticipated complications of iPACK intervention by a questionnaire filled out by the attending anesthesiologist(Up to 24 hours after surgery)
- Incidence of technical difficulties experienced by a questionnaire filled out by the attending anesthesiologist on the day of surgery(24 hours after surgery)
- Comparing duration (in minutes) of tourniquet use during surgery between two groups(During surgery time)
- Number pf participants returning to emergency room in the hospital(Within 30 days after surgery)
- Incidence of the unanticipated motor block from iPACK intervention by a questionnaire filled out by the attending anesthesiologist(Up to 24 hours after surgery)
研究者
Rajrishi Sharma
Assistant Clinical Professor
University of Calgary