A Comparison Between The Efficacy of Modified Thoracoabdominal Plane Block Via Perichondral Approach (M-TAPA) And External Oblique Intercostal Plane Block (EOIPB) in Patients Undergoing Laparoscopic Cholecystectomy Surgeries (LC): A Double-Blinded Randomized Comparative Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- comparing the effectiveness of the modified thoracoabdominal plane block via perichondral approach versus the external oblique intercoastal plane block in reducing pain in laparoscopic cholecystectomy surgery's patients through calculating the mean NRS
研究概览
简要总结
Because laparoscopic procedures have a number of benefits over open procedures, they have completely changed the surgical industry.(1) Laparoscopic cholecystectomy (LC) is a minimally invasive technique that usually yields less discomfort following surgery, shorter hospital stays, and quicker patient recovery, plus it's an economical operation. Nevertheless, it results in moderate to severe pain.(2).By using regional anesthesia techniques to effectively control pain and lessen the requirement for opioid analgesics, ERAS implementation has demonstrated significant decreases in opioid usage and improved overall patient outcomes (3). (4) To minimize the need for opioids, opioid sparing anesthesia employs a multimodal strategy that includes nonsteroidal anti-inflammatory medications, paracetamol, local anesthetics (LA), and, if feasible, regional anesthetic techniques and regional analgesia. (5) With fewer systemic side effects, regional anesthetic techniques-like nerve blocks-offer tailored pain treatment. The best regional pain management strategy for LC surgery is still unknown, though.(4) Modified Thoracoabdominal Nerves Block Through Perichondral Approach (M-TAPA) Block is a new technique defined as a modification of TAPA Block in which local anaesthetics are administered only to the underside of the perichondral surface, creating a sensory block between T5-T12 dermatomes. While the external oblique intercostal plane (EOIPB) block provides blockade of the lateral and anterior cutaneous branches of the intercostal nerves from T6/7 to T10/11.This study aims to compare the efficacy of both MTAPA and EOIPB in patients undergoing LC surgery .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Adults aged 18-65 years
- •Scheduled for Laparoscopic cholecystectomy surgery
- •ASA (American Society of Anaesthesiologists) physical status I-II
排除标准
- •Known allergy to local anaesthetics
- •Coagulopathy or anticoagulant use
- •Infection at the site of block
- •Chronic pain conditions
- •Advanced liver or kidney failure
- •History of abdominal surgery or trauma
- •Alcohol or drug use
- •Refusal to participate
- •Chronic opioid consumption
- •Use of painkillers in the preoperative 24hours
- •Conversion to open surgery
- •Body mass index ( BMI ) > 35
研究组 & 干预措施
Group A
Group A: 30 patients will receive the MTAPA.
干预措施: Bilateral Ultrasound Guidance M-TAPA (Other)
Group B
Group B: 30 patients will receive the EOIPB.
干预措施: Bilateral Ultrasound Guidance EOIPB (Procedure)
结局指标
主要结局
comparing the effectiveness of the modified thoracoabdominal plane block via perichondral approach versus the external oblique intercoastal plane block in reducing pain in laparoscopic cholecystectomy surgery's patients through calculating the mean NRS
时间窗: . NRS scores will be recorded postoperatively upon arrival to PACU and it will be noted as point (0) and then at 20 minutes , and then after the 1st hour , and the at the 6th hour , 12 th hour and 24th hour for a total of 24-hour period.
Numerical Rating Score (NRS) for Pain severity will be measured with a NRS of 0, being no pain , while of 10 being worst pain imaginable. NRS scores will be recorded postoperatively upon arrival to PACU and it will be noted as point (0) and then at 20 minutes , and then after the 1st hour , and the at the 6th hour , 12 th hour and 24th hour for a total of 24-hour period. (11) Patients will be educated and familiarized with NRS scores in the preoperative period. Postoperative, pain control regimen will be used for the two groups as Paracetamol 15mg/kg IV /6hours, Ketorolac 30mg IV /8hours. If the patient's NRS pain score happens to be ≥ 4 points, 10 mg of intravenous nalbuphine Will be given , and the NRS will be repeated again after 15 minutes , if still \> 4 , additional 10 mg IV nalbuphine will be given , with maximum dose of 20 mg per dose , can be repeated up to four times per day with maximum dose of 80 mg per day (18)
次要结局
- time taken to adminsiter the block bilaterally(just after induction of anestheisa intraoperative)
- evaluating the quality of recovery via the QOR-40 questionnaire.(the Quality of Recovery-40 (QoR-40) questionnaire will be used in PACU after 10 minutes from patient arrival to the PACU .)
- identifying dermatomal coverage of each block via pinprick test.(Dermatomal coverage will be tested using pinprick test in PACU after evaluating the QoR-40 within the first hour postoperatively)
- evaluating the efficacy of each block in providing analgesia intraoperatively by measuring amount of fentanyl consumed in micrograms(intraoperatively)
- Total opioid consumption in the first 24 hours postoperatively in mgs(postoperatively with a total of 24 hour)
- Time to first mobilization in hours(postoperatively up to 24 hour)
- the Time to first rescue opioid(it will be measured postoperatively for a total period of 24 hour)
- Incidence of block-related complications(postoperatively with a total of 24 hour)
- Incidence of PONV.(every six hours for a total of 24 hour postoperatively)
研究者
Miran Mohamed Abdelmagyd
Doctor
Kasr El Aini Hospital
