Evaluation of the Effectiveness of Adding Fentanyl to Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 主要终点
- The Visual Analog Scale
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of adding fentanyl to the TAP block in laparoscopic cholecystectomy cases. It is hypothesized that the addition of fentanyl to the TAP block will enhance the quality of postoperative analgesia and prolong the duration of blockade compared to the TAP block performed with bupivacaine alone. The study aims to determine the most effective approach by comparing these two treatment methods with a control group.
详细描述
Cholecystectomy was first performed in 1882 by Karl Langenbuch and is widely used for the treatment of symptomatic gallbladder diseases, such as acute cholecystitis and cholelithiasis. Today, the laparoscopic technique is preferred due to its advantages, including faster recovery, better cosmetic outcomes, and shorter hospital stays. However, despite these benefits, postoperative pain, particularly in the shoulder and abdomen, remains a common issue after laparoscopic surgery and is one of the primary causes of delayed discharge. This pain can be attributed to incision sites, peritoneal irritation caused by the insufflation gas, and trocar entry points.
Effective management of postoperative pain is crucial for accelerating recovery and preventing the development of chronic pain. One of the key strategies in multimodal analgesia is the Transversus Abdominis Plane (TAP) block, which can reduce both postoperative pain and the need for opioids. First described by Rafi in 2001, TAP block gained widespread use after Hebbart et al. demonstrated in 2007 that it could be applied more effectively and safely under ultrasound guidance. The block involves injecting local anesthetics into the neurofascial plane between the transversus abdominis and internal oblique muscles, where the intercostal, subcostal, ilioinguinal, and iliohypogastric nerves run.
Since the identification of opioid receptors in peripheral nerves, there has been interest in combining opioids with local anesthetics to enhance the duration and quality of peripheral nerve blocks. Studies have shown that certain opioids, including fentanyl and sufentanil, exhibit local anesthetic-like effects. Fentanyl, a commonly used opioid, has been shown to improve analgesia quality and prolong the duration of subarachnoid blocks when combined with local anesthetics.
This study aims to evaluate the effectiveness of adding fentanyl to the TAP block, which is routinely performed in our clinic, in laparoscopic cholecystectomy cases. The hypothesis is that the addition of fentanyl to bupivacaine in the TAP block will improve the quality of postoperative analgesia and prolong the block duration.
A total of 66 patients undergoing laparoscopic cholecystectomy will be included in the study. Patients will be randomized into three groups:
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
This study is a double-blind randomized trial. Both the researchers assessing postoperative pain and the participants will be blinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 to 70 years
- •American Society of Anesthesiologists (ASA) classification I-II-III according to the American Society of Anesthesiologists
- •Patients who provide written informed consent
- •Patients scheduled for elective laparoscopic cholecystectomy
排除标准
- •Pregnancy or suspected pregnancy
- •BMI > 35
- •Known allergy to local anesthetics or opioids
- •Suspected coagulopathy or infection at the injection site
- •Severe neurological, psychiatric, cardiovascular, liver, or renal failure
- •Patients converted to open surgery intraoperatively
研究组 & 干预措施
Group 1
Group 1, a unilateral TAP block will be applied using the linear probe (38 mm, 6 MHz) of the ultrasound device routinely used in our clinic. The procedure will be performed in the supine position under aseptic conditions. The ultrasound probe will be placed horizontally in the right subcostal region (an anatomical area following the lower border of the ribs). A 50 mm block needle will be advanced into the fascial plane between the transversus abdominis and rectus abdominis muscles. A total of 20 ml of 0.25% bupivacaine solution will be administered, with a maximum dose of 2 mg/kg.
干预措施: TAP block with bupivacaine only (Procedure)
Group 2
In Group 2, a unilateral TAP block will be applied using the linear probe (38 mm, 6 MHz) of the ultrasound device in the supine position under aseptic conditions. The ultrasound probe will be placed horizontally in the right subcostal region, and a 50 mm block needle will be advanced into the fascial plane between the transversus abdominis and rectus abdominis muscles. A total of 20 ml of block solution containing 0.25% bupivacaine and 50 mcg fentanyl will be administered.
干预措施: TAP block with bupivacaine and fentanyl (Procedure)
Group 3
Patients in Group 3 will serve as the control group, and no block will be applied.
结局指标
主要结局
The Visual Analog Scale
时间窗: 1 day
The Visual Analog Scale (VAS) is a simple and widely used tool to assess the intensity of pain or symptoms. It helps convert patients' subjective experiences (such as pain, discomfort, or fatigue) into a numerical value. This scale is particularly useful in evaluating postoperative pain and chronic pain conditions. How Does VAS Work? The VAS typically consists of a 10 cm horizontal or vertical line. One end of the line is labeled "No Pain", and the other end is labeled "Worst Pain Possible". The patient is asked to mark a point on the line that best represents their pain intensity. The marked point is measured with a ruler to obtain a score between 0 and 10. VAS Scoring: VAS Score Pain Level 0 No pain 1-3 Mild pain 4-6 Moderate pain 7-10 Severe and unbearable pain Areas of Use: Postoperative pain assessment Chronic pain management Conditions like migraine, arthritis, or cancer pain Evaluating physical and emotional symptoms (e.g., anxiety or depression)
次要结局
- Rescue Analgesic Requirement(1 day)
- The 5-point Likert scale(1 day)
研究者
Mustafa Çabuk
Resident Doctor
Uludag University