Evaluation of The Postoperative Analgesic Effectivity of Erector Spina Plane Block With Different Injection Levels on Patients Undergoing Laparoscopic Cholecystectomy Surgery : A Randomised Controled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Postoperative pain change
研究概览
简要总结
In last years, erector spinae plane block is widely used in abdominal and thoracic surgeries. Laparoscopic cholecystectomy is one of the most commonly performed surgical operations. In this study, the investigators will evaluate the effectiveness of erector spina plan block with different injection levels for postoperative analgesia on patients undergoing laparoscopic cholecystectomy surgery.
详细描述
Three groups were planned for this study.Randomization was planned with the closed envelope method. İn the first group, the ESP(erector spinae plane) block procedure will be applied from the T7 level bilaterally and in the second group it will be applied from the T9 level bilaterally. ESP block procedure will not be applied in the third group and this group will be considered as the control group. A comparison of NRS (Numeric Rating Scale) and morphine consumption will be planned for all groups of patients at 1-th, 4-th, 8-th.,12-th and,24-th postoperative hours.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA 1-2 Elective cholecystectomy surgery
- •18-65 years old patients
排除标准
- •ASA 3-4 patients
- •Patient refusal
- •several lung and heart disease
- •Contraindications to regional anesthesia
- •BMİ > 35 patients
- •Known allergy to local anesthetics
- •Bleeding diathesis
- •Use of any anti-coagulants
- •Severe kidney or liver disease
- •Patient with psychiatric disorders
研究组 & 干预措施
T7 Bilateral ESP block
Ultrasound-guided bilateral Erector spinae plane block will performe at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture by imaging T7 (7th thoracal vertebrae ) transverse process accompanied by ultrasound. Postoperative routine analgesic protocol planned (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block). Standard pain follow-up and monitorization will be performed.
干预措施: T7 Level Erector Spinae Plane Block (Procedure)
T9 bilateral ESP block
Ultrasound-guided bilateral Erector spinae plane block will performe at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture by imaging transverse process T9 (9th thoracal vertebrae) by ultrasound. Postoperative routine analgesic protocol planned (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block). Standard pain follow-up and monitorization will be performed.
干预措施: T9 Level Erector Spinae Plane Block (Procedure)
Control group
Postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard pain follow-up and monitorization will be performed. No block will be performed in this group.
干预措施: control group (Drug)
结局指标
主要结局
Postoperative pain change
时间窗: up to 24 hours
It was planned to check the change in the NRS scores of patients at 1.,4.,8.,12.,24 hours for evaluation of efficacy level and effect time of ESP block procedure from different levels. A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain.
Postoperative morphine consumption change
时间窗: up to 24 hours
It was planned to check the change in the morphine consumption of patients at 1.,4.,8.,12.,24 hours for evaluation of efficacy level and effect time of ESP block procedure from different levels.
次要结局
- side effects(up to 24 hours)
- number of blocked dermatome sites(up to 24 hours)
研究者
SERPİL ŞEHİRLİOĞLU
Attending Anesthesiologist
Gaziosmanpasa Research and Education Hospital