Effect of 4 Point TAP Block on Diaphragm Thickness in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Diaphragma thickness as milimeter
研究概览
简要总结
Hypothesis: Postoperative pain, by preventing effective diaphragmatic contraction, hinders deep inspiration and expiration. Inspiratory and expiratory levels can be assessed by measuring diaphragm thickness using ultrasound.Diaphragm thickness[DT] measured at the end of inspiration and expiration will differ between patients who undergo Transversus Abdominis Plane Block[TAP] block using the 4-point technique and those who do not. It is anticipated that in patients who receive the block, diaphragm thickness will be greater, serving as an indicator of
详细描述
Postoperative pain is among the main reasons for the decrease in respiratory function after upper abdominal surgery. Numerous studies have investigated the relationship between pain and respiratory function in abdominal surgeries. While the classic TAP block is used to relieve lower abdominal pain [Th10-Th12] after surgery, it may be insufficient in relieving pain in the upper abdominal wall [Th6-Th9]. The 4-point TAPb technique is employed to address the pain in this region. Ultrasound allows for non-invasive assessment of changes in diaphragm thickness along with changes in lung volume, and evaluating diaphragm mass and contraction is highly useful in diagnosing respiratory diseases. Previous studies have explored changes in diaphragm thickness and the relationship between total lung capacity [TLC], functional residual capacity [FRC], residual volume [RV] and diaphragm function. However, changes in diaphragm function due to pain prevention in patients undergoing '4-point' TAPb are not well understood. It is aimed to investigate the impact of the 4-point TAP block on the diaphragm in patients undergoing laparoscopic cholecystectomy under general anesthesia. The primary objective of this study is to use ultrasound to examine the effect of the four-point TAP block, administered for analgesia after laparoscopic cholecystectomy, on diaphragm thickness. The secondary objective is to assess the impact of the four-point TAP block on pain and the quality of patient recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Written informed consent;
- •18-65 years old;
- •ASA Physical Status 1-2;
- •Scheduled for elective kolesistektomi.
排除标准
- •≤18, ≥65 years old;
- •Any contraindications nerve blocks;
- •VKİ>35 kg/m2;
- •Bleeding diathesis;
- •Switching to open surgery;
- •Language barrier;
- •Having undergone upper abdominal surgery previously;
- •Severe kind of chronic lung ilness;
- •Contraindication or allergy to planned drugs.
研究组 & 干预措施
Group B: Transabdominal plane block group
Patients agreeing to participate will be allocated to the control group (Group C, n=25) or the block group (Group B, n=25). The allocation will be randomized using a web-based data entry and randomization platform (by using envelope selection method) by an anesthesiologist not involved in the study. At the end of the surgery, patients in Group B will receive a four-point TAP block.
干预措施: Transabdominal plane block (Procedure)
Group C: Control group with multi-modal analgesia
Patients agreeing to participate will be allocated to the control group (Group C, n=25) or the block group (Group B, n=25). The allocation will be randomized using a web-based data entry and randomization platform (by using envelope selection method) by an anesthesiologist not involved in the study. At the end of the surgery, patients in Group C which will be performed no interventional procedures.
结局指标
主要结局
Diaphragma thickness as milimeter
时间窗: Preoperative measurement of DT and postoperative measurement of DT(5. minutes and 30. minutes)
Measurement of Diaphragm Thickness: Patients will be placed in a supine position with the head elevated 30 degrees, and high-frequency linear probe ultrasound (DC-60 Diagnostic Ultrasound, Shenzhen Mindray, China) will be used to visualize the diaphragm in its characteristic three-layered appearance above the anterior axillary line at the aponeurosis region (lung-pleura). The hypoechoic (dark) muscle tissue between the two hyperechoic (bright) lines of pleural and peritoneal fascia will be imaged, and the thickness will be measured and recorded.
次要结局
- Opioid consumption as miligram per day(2, 8, and 24 hours postoperatively assessments)
- Visual Analog Scale (from 1 to 10)(VAS assessment preoperatively and postoperatively at 5 minutes, 30 minutes, 2 hours, 8 hours, and 24 hours.)
- Quality of Recovery-15T score (from 0 to150)(24 hours postoperatively assessments)
研究者
Nuran Akıncı Ekinci
Medical Doctor
Konya City Hospital