Sensory Analysis and Cutaneous Mapping of Different Regional Anesthesia Techniques in Laparoscopic Cholecystectomy Surgery: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cutaneous Sensory Block Area of EOPB and SIPB
研究概览
简要总结
This prospective observational study aims to evaluate and compare the sensory block distribution and regression patterns of two regional anesthesia techniques - External Oblique Plane Block (EOPB) and Serratus Intercostal Plane Block (SIPB) - in patients undergoing laparoscopic cholecystectomy.
Thirty adult patients (ASA I-III, BMI ≤ 35 kg/m², ≥50 kg) scheduled for elective laparoscopic cholecystectomy procedures will be included, with 20 in each block group. Sensory block areas will be assessed using pinprick test, and dermatomal mapping will visualize the spread. The findings are expected to improve understanding of block behavior and guide multimodal analgesia strategies in laparoscopic cholecystectomy.
详细描述
This single-center, prospective observational study will be conducted at Samsun University Training and Research Hospital operating rooms between November 2025 and June 2026.
The study will include patients aged 18-75 years, classified as ASA I-III, who are scheduled for elective laparoscopic cholecystectomy and have provided written informed consent. For pain management, these patients will undergo either serratus intercostal plane block (SIPB) or external oblique plane block (EOPB) under ultrasound guidance. Patients receiving one of these two block techniques will be observed, and the sensory block areas created will be evaluated.
Both blocks will be performed bilaterally and under ultrasound guidance immediately before surgery. 0.25% bupivacaine will be used for the block applications, and 25 mL of local anesthetic will be injected into each side (a total of 50 mL). Thirty minutes after the block, patients will be evaluated for cutaneous sensory block using the "pinprick test." This evaluation will be standardized according to specific dermatome levels, covering the midline and both abdominal quadrants, in order to describe sensory loss on the skin.
The data obtained will be analyzed to determine the dermatomal spread and the minimum and maximum areas of effect of the blocks. Additionally, findings related to block application time will be recorded observationally. A comparison between the groups will be made, and the degree of overlap between the sensory block areas and the surgical incision site will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective laparoscopic cholecystectomy surgery and who have received a regional anesthesia technique for this purpose.
- •Aged between 18-75 years.
- •Belonging to ASA I-III group.
- •Having provided written informed consent.
排除标准
- •Patients who refuse to participate.
- •Patients who did not receive a block.
- •Patients classified as ASA IV.
- •History of previous abdominal surgery (affecting the laparoscopic approach).
- •Patients with cognitive dysfunction or inability to cooperate.
- •Patients diagnosed with psychiatric disorders (schizophrenia, mania, depression, etc.).
- •Patients who have been using antipsychotic medication for more than 4 weeks.
研究组 & 干预措施
EOPB Group
Patients undergoing laparoscopic cholecystectomy who receive an ultrasound-guided External Oblique Plane Block (EOPB) for postoperative analgesia.
Bilateral blocks will be performed using 0.25% bupivacaine (25 mL per side, total 50 mL). Sensory block areas will be evaluated using pinprick at predefined time points.
干预措施: External Oblique Plane Block (EOPB) (Procedure)
SIPB Group
Patients undergoing laparoscopic cholecystectomy who receive an ultrasound-guided Serratus Intercostal Plane Block (SIPB) for postoperative analgesia.
Bilateral blocks will be performed using 0.25% bupivacaine (25 mL per side, total 50 mL). Sensory block areas will be evaluated using pinprick at predefined time points.
干预措施: Serratus Intercostal Plane Block (SIPB) (Procedure)
结局指标
主要结局
Cutaneous Sensory Block Area of EOPB and SIPB
时间窗: 30 minutes after block application
The primary outcome is the dermatomal mapping of the cutaneous sensory block areas produced by the serratus intercostal plane block (SIPB) and external oblique plane block (EOPB), and the comparison of sensory block extent between the two techniques.
次要结局
- Coverage of Surgical Port Entry Sites by the Sensory Block Area(30 minutes after block application)
- Maximum and Minimum Spread of the Cutaneous Sensory Block Area(30 minutes after block application)
- Block Application Duration(From needle insertion to completion of local anesthetic injection)