Evaluation of Post-Operative Analgesic Efficacy of Bilateral External Oblique Intercostal Plane Block Versus Wound Site Infiltration Control Group in Patients Underwent Laparoscopic Cholecystectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- NRS (Numeric Rating Skore)
研究概览
简要总结
Laparoscopic cholecystectomy, while less painful compared to conventional methods, is still a surgery that can cause significant pain for patients. Preventing postoperative pain is crucial for reducing respiratory complications, shortening hospital stays, and increasing patient satisfaction. Interfascial plane blocks have been widely used for postoperative analgesia in recent years worldwide. The External Oblique Intercostal Plane Block is one of the interfascial plane blocks used in abdominal surgeries. In our study, we aimed to compare the postoperative pain scores of patients who underwent laparoscopic cholecystectomy under general anesthesia, specifically between those who received the external oblique intercostal plane block and those who had trocar entry site infiltration.
详细描述
Despite the advancements in surgical and anesthesia techniques, pain following surgical interventions remains a significant issue concerning patient health and comfort today. The physiological response resulting from surgical trauma and stress can lead to various unwanted conditions in the pulmonary, cardiovascular, gastrointestinal, metabolic, and neuroendocrine systems. These complications negatively impact wound healing, length of hospital stay, and costs. The primary goal in managing pain after surgery is to facilitate the healing process, avoid potential side effects associated with analgesic treatments, and enhance patient comfort.
Cholecystectomy, which plays a significant role among abdominal surgical interventions, can currently be performed using two distinct techniques: open and laparoscopic.
Laparoscopic cholecystectomy is considered the gold standard treatment for symptomatic cholelithiasis due to its ability to cause less trauma compared to open surgery, facilitate faster recovery in patients, result in less postoperative pain, and allow patients to return to their normal lives more quickly.
There are three components of postoperative pain observed after laparoscopic cholecystectomy. These include somatic pain associated with the laparoscopic trocar entry incisions in the anterior abdominal wall, visceral pain due to pneumoperitoneum and surgical dissection of the gallbladder, and referred shoulder pain resulting from the stimulation of the phrenic nerve by residual carbon dioxide gas.
Effective management of postoperative pain is crucial for reducing respiratory complications, shortening hospital stay, and increasing patient satisfaction. In this context, both nonsteroidal intravenous analgesics and opioids are used. However, opioids have undesirable side effects, including respiratory depression, nausea and vomiting, and reduced gastrointestinal motility. Therefore, multimodal analgesia methods that combine intravenous analgesics with regional anesthesia are preferred, allowing for the reduction of drug-related side effects while providing safe and effective postoperative analgesia.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The participants and outcomes assessor wil be blinded
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
- 否
入选标准
- •Patients aged 18 to 65 who will be scheduled for an elective laparoscopic cholecystectomy under general anesthesia
- •ASA (American Society of Anesthesiologists) I-II-III
排除标准
- •presence of coagulation disorder
- •infection at the injection site of the block
- •known allergy to local anesthetics
- •advanced hepatic, heart or renal failure
- •history of abdominal surgery or trauma
- •conversion of laparoscopic to open surgery
- •consumption of any pain killers within the 24 h before the operation
- •chronic opioid consumption
- •pregnancy
- •alcohol or drug abuse
- •body mass index (BMI) ≥ 35 kg m-2
- •Impairment of the patient's cognitive functions (such as Alzheimer's disease, dementia, etc.).
- •Cholecystectomy cases performed under emergency conditions.
研究组 & 干预措施
Grup E (External Oblique Intercostal Plane Block)
At the end of the surgical procedure,a high-frequency linear probe will be sterilely covered,and an 80mm block needle will be used for the procedure.Under sterile conditions,the ultrasound probe will be placed in a parasagittal position in the area between the anterior axillary line and the midclavicular line at the level of the 10th rib, and then slid cranially along the longitudinal axis to the level of the 6th and 7th ribs. After visualizing the external oblique muscle, the block needle will be inserted using an in-plane technique,and 5ml of saline will be administered to confirm the location at the external oblique intercostal plane between the external oblique muscle and the 6th rib. Once the location is confirmed, 20cc of 0.25%bupivacaine will be infiltrated into the EOIP. The same procedure will be applied to the opposite side (totally 40 ml).
干预措施: ultrasound guided external oblique intercostal plane block (Device)
Grup E (External Oblique Intercostal Plane Block)
At the end of the surgical procedure,a high-frequency linear probe will be sterilely covered,and an 80mm block needle will be used for the procedure.Under sterile conditions,the ultrasound probe will be placed in a parasagittal position in the area between the anterior axillary line and the midclavicular line at the level of the 10th rib, and then slid cranially along the longitudinal axis to the level of the 6th and 7th ribs. After visualizing the external oblique muscle, the block needle will be inserted using an in-plane technique,and 5ml of saline will be administered to confirm the location at the external oblique intercostal plane between the external oblique muscle and the 6th rib. Once the location is confirmed, 20cc of 0.25%bupivacaine will be infiltrated into the EOIP. The same procedure will be applied to the opposite side (totally 40 ml).
干预措施: paracetamol, tramadol, and ondansetron (Drug)
Grup T ( Trocar entry site infiltration)
After the trocar removed during the surgical procedure, the surgeon will administer 5 ml of 0.25% bupivacaine infiltration to each trocar entry site.
干预措施: Bupivacaine injection (Drug)
Grup T ( Trocar entry site infiltration)
After the trocar removed during the surgical procedure, the surgeon will administer 5 ml of 0.25% bupivacaine infiltration to each trocar entry site.
干预措施: paracetamol, tramadol, and ondansetron (Drug)
结局指标
主要结局
NRS (Numeric Rating Skore)
时间窗: Postoperative 24 hours
The primary outcome variable is Numerical Rating Scale scores both at rest and motion. A blinded anesthesiologist will assess postoperative pain during rest and motion at the postoperative 15th,30th and 60th minute, second,6th, 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable).
次要结局
- Opioid Consumption(Postoperative 24 hours)
- Time to first rescue analgesic(Postoperative 24 hours)
- Adverse Events(Postoperative 24 hours)
- Metoclopromide Consumption(Postoperative 24 hours)
- Quality of recovery levels between groups by using QoR-15 questionnaire(Postoperative 24 hours)
