Comparison of Local Anesthetic Dose in PENG (Pericapsular Nerve Group) Block Performed for Postoperative Analgesia in Total Hip Replacement Operations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (0-10) pain scores for patients
研究概览
简要总结
The investigators research was designed as a single-center, prospective, randomized double-blind study. The patients undergoing total hip replacement surgery in Istanbul University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be included. Patients or persons 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 PENG 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.
PENG block will be done for postoperative analgesia. After the PENG block, 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. Measurements made at 5-minute intervals will be recorded.
In the investigators clinic, the use of PENG 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.
The local anesthetic solution given by the supervisor, whose doses of local anesthetic are predetermined (the investigators and participants do not know the dosage), with a total volume of 20 cc will be used. Local anesthetic agent will not be applied to the control group. As mentioned above, spinal anesthesia will be performed after PENG block and the operation will be started.
Pain score and total morphine consumption will be determined by visual pain scoring (VAS) at the postoperative 0, 6, 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 VAS>4 after each interrogation, morphine 0.05 mg/kg iv will be administered as additional analgesia and the maximum will be increased to 10 mg. Pain management will continue when VAS <4.
详细描述
The investigators research was designed as a single-center, prospective, randomized double-blind study. After the approval of the Ethics Committee, the study will start and is aimed to be completed in 12 months.
The patients undergoing total hip replacement surgery in Istanbul University Istanbul Medicine Faculty Department of Orthopedics and Traumatology will be included. Patients or persons 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' Vas 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 PENG 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.
PENG block will be done for postoperative analgesia. After the PENG block, 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.
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
- 是
入选标准
- •Patients scheduled for total hip replacement 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
- •Increased intracranial pressure (Brain tumors)
- •Known allergy against local anesthetics
- •Anatomical difficulties
研究组 & 干预措施
Group 1
In this group, US guided PENG block will be performed with 20 ml 0.5% bupivacaine using a 22 gauge 10 mm block needle.
干预措施: Bupivacaine HCl 0.5 % in 20 ML Injection (Drug)
Group 2
In this group, US guided PENG block will be performed with 20 ml 0.25% bupivacaine using a 22 gauge 10 mm block needle.
干预措施: Bupivacaine HCl 0.25 % in 20 ML Injection (Drug)
Group 3
In this group, US guided PENG block will be performed with 20 ml 0.125% bupivacaine using a 22 gauge 10 mm block needle.
干预措施: Bupivacaine HCl 0.125 % in 20 ML Injection (Drug)
Group 4
In this group, US guided PENG block will be performed with 20 ml saline solution (%0.9 NaCl) using a 22 gauge 10 mm block needle.
干预措施: NaCl 0.9% (Drug)
结局指标
主要结局
Visual Analogue Scale (0-10) pain scores for patients
时间窗: Up to 48 hours
The VAS (Visual Analog Scale, 0 mm ''no pain'', to 100 mm, ''the worst pain possible'')
次要结局
- Time of onset of narcotic analgesic need(during surgery and postoperative period up to 48th hours.)
- Opioid (mg) consumption(during surgery and postoperative period up to 48th hours.)
- Length of hospital stay(Through study completion, an average of 1 week)
- Patient satisfaction(postoperative period up to 48th hours and postoperative in the first month)
- Incidence of side effects(during surgery and postoperative period up to 48th hours.)
- Surgeon satisfaction(postoperative period up to 48th hours and postoperative in the first month)
- Beck depression inventory scores(Will be done 3 times 1- on pre-operative hospitalization 2- in the hospital after surgery 3- in the 1st month follow-up after surgery)
- Incidence of quadriceps weakness(postoperative period up to 48th hours and postoperative in the first month)
- Time until postoperative first mobilization(Up to 48 hours)
研究者
Nur Canbolat
Principal Investigator, M.D.
Istanbul University