Comparison of Local Anesthetic Dose in IPACK (Interspace Between the Popliteal Artery and the Posterior Capsule of the Knee) Block Performed for Postoperative Analgesia in Knee Artroplasty Operations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Opioid (mg) consumption
研究概览
简要总结
The investigators research was designed as a single-center, prospective, randomized study. The patients undergoing knee artrhroplasty surgery in Istanbul University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will not be included in the study.
Patients will be given US guided IPACK and adductor blocks using a 22 gauge 10 mm block needle after compliance with the rules of asepsia and antisepsis in the supine position according to the group of patients in which they were included.
IPACK and adductor block will be done for postoperative analgesia. After then, a single dose of spinal anesthesia will be applied as a regional anesthesia method, in a sitting position, using the appropriate spinal needle, as is routinely applied in the investigators clinic. After the block is completed, the pinprick test will be done and the operation will be started after the successful completion of the block is confirmed. Oxygen will be given to the patients with a face mask at 4 lt / min throughout the operation. ECG, saturation, invasive / noninvasive blood pressure monitoring of the patients will be done.
In the investigators clinic, the use of IPACK block, adductor block and PCA (patient controlled analgesia) device with intravenous morphine for postoperative analgesia is routinely performed. In this study, four randomized groups will be formed together with the control group.
IPACK block will be applied to the 1st group with 10 ml of 0.25% bupivacaine, to the 2nd group with 15 ml of 0.25% bupivacaine, and to the 3rd group with 20 ml of 0.25% bupivacaine.Adductor block will be applied to all the groups with 15 ml %0,25 bupivacaine and PCA (patient controlled analgesia) device with intravenous morphine for postoperative analgesia is performed.
Pain score and total morphine consumption will be determined by numeric rating scale (NRS) at the postoperative 1, 4, 8, 12, 24 and 48th hours by providing the use of a PCA device with intravenous morphine applied in routine practice to all four groups. As in routine practice, when NRS > 4 after each interrogation, morphine 2 mg iv will be administered as additional analgesia and the maximum will be increased to 10 mg. Pain management will continue when NRS < 4.
详细描述
The investigators research was designed as a single-center, prospective, randomized study.
The patients undergoing knee arthroplasty in Istanbul University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will not be included in the study.
Patients will be evaluated preoperative before surgery, a detailed history will be taken and physical examination will be carried out. Medical and surgical resume information will be obtained. Patients' NRS scores will be recorded before the operation. Patients will be taken to the operating room after premedication.
ECG, pulse oximeter, blood pressure monitoring will be performed in the operating room. Patients will be given US guided IPACK and adductor blocks using a 22 gauge 10 mm block needle after compliance with the rules of asepsia and antisepsis in the supine position according to the group of patients in which they were included.
IPACK and adductor block will be done for postoperative analgesia. After then, a single dose of spinal anesthesia will be applied as a regional anesthesia method, in a sitting position, using the appropriate spinal needle, as is routinely applied in the investigators clinic. After the block is completed, the pinprick test will be done and the operation will be started after the successful completion of the block is confirmed. Oxygen will be given to the patients with a face mask at 4 lt / min throughout the operation.ECG, saturation, invasive / noninvasive blood pressure monitoring of the patients will be done.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 knee arthroplasty surgery under regional anesthesia
- •ASA(American Society of Anesthesiology) 1-3
- •Receiving consent that accept regional analgesia
排除标准
- •Refusal of regional anesthesia
- •Infection on the local anesthetic application area
- •Infection in the central nervous system
- •Coagulopathy
- •BMI > 40
- •Known allergy against local anesthetics
研究组 & 干预措施
Group 1:10 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
In this group,US guided IPACK block will be performed with 10 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle.
干预措施: Bupivacaine (Drug)
Group 1:10 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
In this group,US guided IPACK block will be performed with 10 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle.
干预措施: Morphine Sulfate (Drug)
Group 2:15 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
In this group,US guided IPACK block will be performed with 15 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle.
干预措施: Bupivacaine (Drug)
Group 2:15 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
In this group,US guided IPACK block will be performed with 15 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle.
干预措施: Morphine Sulfate (Drug)
Group 3:20 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
In this group,US guided IPACK block will be performed with 20 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle.
干预措施: Bupivacaine (Drug)
Group 3:20 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
In this group,US guided IPACK block will be performed with 20 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle.
干预措施: Morphine Sulfate (Drug)
Group 4:15 ml %0,25 bupivacaine adductor block and intravenous patient controlled analgesia
In this group adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle and postoperative patient controlled analgesia with morphine will be preferred for postoperative analgesia method.
干预措施: Bupivacaine (Drug)
Group 4:15 ml %0,25 bupivacaine adductor block and intravenous patient controlled analgesia
In this group adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle and postoperative patient controlled analgesia with morphine will be preferred for postoperative analgesia method.
干预措施: Morphine Sulfate (Drug)
结局指标
主要结局
Opioid (mg) consumption
时间窗: postoperative period up to 48th hours
Opioid (mg) consumption
Numeric Rating Scale(0-10)pain scores for patients.
时间窗: postoperative period up to 48 hours
NRS(Numeric Rating Scale),0:no pain,10:the worst pain.
次要结局
- The Medical Research Council (MRC) Scale for Muscle Strength for lower extremity(Discharge 1 day from the hospital)
- Surgeon satisfaction(Postoperative period up to 48th hours)
- Incidence of side effects(postoperative period up to 48th hours)
- Time until postoperative first mobilization(Up to 48 hours)
- Length of hospital stay(Through study completion, an average of 1 week.)
- Womac osteoarthritis index(Discharge 1 day from the hospital)
- Patient satisfaction(Postoperative period up to 48th hours)
- Joint range of motion(Postoperative period up to 48th hours, discharge 1 day)
研究者
Nur Canbolat
Principal Investigator, M.D.
Istanbul University