Postoperative Analgesic Effectiveness of Superficial Plane Blocks in Laparoscopic Cholecystectomy: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity at Rest and With Movement
研究概览
简要总结
This prospective, single-center observational study will evaluate postoperative analgesia in adults undergoing elective laparoscopic cholecystectomy. Participants will receive routine anesthetic care selected by the responsible anesthesiologist and will be observed in one of three groups: rectointercostal plane block, external oblique-rectus abdominis plane (EXORA) block, or intravenous patient-controlled analgesia (IV PCA). The study will compare postoperative pain scores and sensory block spread. Pain at rest and with movement will be assessed using the 0-to-10 Numeric Rating Scale at 0, 2, 4, 6, 12, and 24 hours after surgery. Sensory spread will be assessed by pinprick testing across the T4-T12 dermatomes at 30 minutes after surgery. Additional assessments will include 24-hour tramadol consumption, postoperative nausea and vomiting, and block-related complications.
详细描述
The study will prospectively enroll 90 adults aged 18 to 85 years who are scheduled for elective laparoscopic cholecystectomy at Bursa Yuksek Ihtisas Training and Research Hospital. The choice of postoperative analgesic technique will be made by the responsible anesthesiologist as part of routine clinical care; the investigators will not assign participants to an analgesic technique. Participants will be evaluated according to the routine care they receive: rectointercostal plane block, EXORA block, or intravenous patient-controlled analgesia. Investigators will record demographic and clinical characteristics, operative and anesthetic information, the analgesic technique used, local anesthetic type and volume when applicable, and tramadol use. Pain at rest and during movement will be measured with the Numeric Rating Scale at 0, 2, 4, 6, 12, and 24 hours postoperatively. For participants receiving a plane block, dermatomal sensory spread from T4 through T12 will be assessed by pinprick testing at 30 minutes after surgery. The study will also record cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting, and block-related complications.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 85 years
- •Scheduled to undergo elective laparoscopic cholecystectomy
- •American Society of Anesthesiologists physical status I, II, or III
- •Provision of written informed consent
排除标准
- •Age younger than 18 years or older than 85 years
- •Known allergy to local anesthetics
- •Coagulopathy
- •Presence of infection
- •Pregnancy
- •Cognitive impairment
- •Body mass index greater than 35 kg/m²
研究组 & 干预措施
Intravenous Patient-Controlled Analgesia Group
Participants managed with intravenous patient-controlled analgesia as selected by the responsible anesthesiologist during routine clinical care.
干预措施: Intravenous Patient-Controlled Analgesia With Tramadol (Drug)
Rectointercostal Plane Block Group
Participants who receive a rectointercostal plane block as selected by the responsible anesthesiologist during routine clinical care.
干预措施: Rectointercostal Plane Block (Procedure)
Rectointercostal Plane Block Group
Participants who receive a rectointercostal plane block as selected by the responsible anesthesiologist during routine clinical care.
干预措施: Intravenous Patient-Controlled Analgesia With Tramadol (Drug)
EXORA Block Group
Participants who receive an external oblique-rectus abdominis plane (EXORA) block as selected by the responsible anesthesiologist during routine clinical care.
干预措施: External Oblique-Rectus Abdominis Plane Block (Procedure)
EXORA Block Group
Participants who receive an external oblique-rectus abdominis plane (EXORA) block as selected by the responsible anesthesiologist during routine clinical care.
干预措施: Intravenous Patient-Controlled Analgesia With Tramadol (Drug)
结局指标
主要结局
Postoperative Pain Intensity at Rest and With Movement
时间窗: 0, 2, 4, 6, 12, and 24 hours after surgery
Participant-reported pain intensity will be measured separately at rest and during movement using an 11-point Numeric Rating Scale ranging from 0 to 10, with higher scores indicating greater pain.
次要结局
- Sensory Block Distribution Assessed by Pinprick(30 minutes after surgery)
- Cumulative Tramadol Consumption(During the first 24 hours after surgery)
- Incidence of Postoperative Nausea and Vomiting(During the first 24 hours after surgery)
- Incidence of Block-Related Complications(During the first 24 hours after surgery)
研究者
Korgün Ökmen
Professor of Anesthesiology and Reanimation
Bursa Yuksek Ihtisas Training and Research Hospital