Evaluation of Multimodal Analgesia Methods in Patients Who Underwent IPACK Block in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- NRS Pain Scores
研究概览
简要总结
A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)/ Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) - in patients undergoing total knee arthroplasty. dexketoprofen and paracetamol will be added to both groups and multimodal analgesia will be applied. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).
详细描述
Postoperative pain after total knee arthroplasty is serious and difficult to management. Multimodal analgesia recommended for the pain management. For these reasons, we planned a study involving two multimodal analgesia regimens. Patients who will undergo total knee arthroplasty will receive preemptive oral analgesic (dexketofrofen) 1 hour before the operation. Surgery will be initiated after spinal anesthesia is applied to the patients. Two pain control methods - the combination of Adductor Canal Block (ACB)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI)/ IPACK- will be applied at the end of the surgery. dexketoprofenand paracetamol will be added to both groups and multimodal analgesia will be applied. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty with a participating surgeon
- •Age 18 to 80 years
- •Planned use of regional anesthesia
- •Ability to follow study protocol
- •Patients of participating surgeons
排除标准
- •Hepatic or renal insufficiency
- •Younger than 18 years old and older than 80
- •Patients undergoing general anesthesia
- •Allergy or intolerance to one of the study medications
- •BMI > 40
- •ASA of IV
- •Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- •Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month)
研究组 & 干预措施
Peri-Articular Injections and IPACK
Spinal anesthetic with 2,5 ml 0,5% heavy bupivacaine
At the end of surgery;
PAI: 30 ml 0,025% bupivacaine and
IPACK: 20 ml 0,025% bupivacaine
干预措施: IPACK (Other)
Peri-Articular Injections and IPACK
Spinal anesthetic with 2,5 ml 0,5% heavy bupivacaine
At the end of surgery;
PAI: 30 ml 0,025% bupivacaine and
IPACK: 20 ml 0,025% bupivacaine
干预措施: Dexketoprofen Trometamol (Drug)
Peri-Articular Injections and IPACK
Spinal anesthetic with 2,5 ml 0,5% heavy bupivacaine
At the end of surgery;
PAI: 30 ml 0,025% bupivacaine and
IPACK: 20 ml 0,025% bupivacaine
干预措施: spinal anesthesia (Other)
Peri-Articular Injections and IPACK
Spinal anesthetic with 2,5 ml 0,5% heavy bupivacaine
At the end of surgery;
PAI: 30 ml 0,025% bupivacaine and
IPACK: 20 ml 0,025% bupivacaine
干预措施: PAI (Other)
Adductor Canal Block, and IPACK
Spinal anesthetic with 2,5 ml 0,5% heavy bupivacaine
At the end of surgery;
ADD: 20 ml 0,025% bupivacaine and
IPACK: 20 ml 0,025% bupivacaine
干预措施: Dexketoprofen Trometamol (Drug)
Adductor Canal Block, and IPACK
Spinal anesthetic with 2,5 ml 0,5% heavy bupivacaine
At the end of surgery;
ADD: 20 ml 0,025% bupivacaine and
IPACK: 20 ml 0,025% bupivacaine
干预措施: spinal anesthesia (Other)
Adductor Canal Block, and IPACK
Spinal anesthetic with 2,5 ml 0,5% heavy bupivacaine
At the end of surgery;
ADD: 20 ml 0,025% bupivacaine and
IPACK: 20 ml 0,025% bupivacaine
干预措施: IPACK (Other)
Adductor Canal Block, and IPACK
Spinal anesthetic with 2,5 ml 0,5% heavy bupivacaine
At the end of surgery;
ADD: 20 ml 0,025% bupivacaine and
IPACK: 20 ml 0,025% bupivacaine
干预措施: Adductor canal block (Other)
结局指标
主要结局
NRS Pain Scores
时间窗: 24 hours post block administration
NRS Pain scores with ambulation 24 hours post block administration.All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
次要结局
- NRS at Rest and with movement(24 hours on Post-Operative Day 1)
- Patient Satisfaction with Pain Control using the likert scale(Post-Operative 24 hours)
研究者
ilkay baran akkuş
Principal Investigator
Ankara Diskapi Training and Research Hospital