Investigation of the Postoperative Effectiveness of Fascial Plane Blocks Used for Analgesia in Patients Undergoing Breast 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
- 90
- 试验地点
- 1
- 主要终点
- Cumulative Tramadol Consumption During the First 24 Hours After Surgery
研究概览
简要总结
This prospective, single-center observational study will compare postoperative pain control in adults undergoing elective breast surgery. Ninety participants will be evaluated in three groups based on routine clinical care: rhomboid intercostal plane block, serratus posterior superior intercostal plane block, and control. The anesthesia method and fascial plane block will be selected by the treating anesthesiologist, and the research team will not assign participants to a group. The main outcome is the total amount of tramadol used through patient-controlled analgesia during the first 24 hours after surgery. Pain scores at rest and during movement, sensory block levels, postoperative nausea and vomiting, and block-related complications will also be recorded.
详细描述
Patients aged 18 to 80 years who are scheduled for elective breast surgery under general anesthesia and meet the eligibility criteria will be enrolled after providing written informed consent. Group classification will reflect the regional analgesia approach selected as part of routine care by the treating anesthesiologist. The investigators will not participate in the selection of the anesthesia method, the fascial plane block, or the study group.
The study will include 90 participants in three observational cohorts: rhomboid intercostal plane block, serratus posterior superior intercostal plane block, and control. The primary outcome is cumulative tramadol consumption recorded by patient-controlled analgesia during the first 24 postoperative hours. Secondary assessments include Numeric Rating Scale pain scores at rest and during movement at postoperative hours 0, 2, 4, 6, 12, and 24; sensory block level assessed by pinprick testing in the block groups; 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years
- •ASA physical status I to III
- •Undergoing surgery under general anesthesia
- •Provision of written informed consent
- •Scheduled for elective breast surgery
排除标准
- •History of allergy to local anesthetic medications
- •Coagulation disorder
- •Body mass index greater than 40 kg/m2
- •Infection at the block application site
- •Chronic pain syndrome
- •Pregnancy
- •Inability to communicate
- •Requirement for emergency surgery
研究组 & 干预措施
Rhomboid Intercostal Plane Block Group
Participants undergoing elective breast surgery who receive a rhomboid intercostal plane block as selected by the treating anesthesiologist during routine clinical care. The local anesthetic type and dose used for the block will be recorded.
干预措施: Rhomboid intercostal plane block (Procedure)
Serratus Posterior Superior Intercostal Plane Block Group
Participants undergoing elective breast surgery who receive a serratus posterior superior intercostal plane block as selected by the treating anesthesiologist during routine clinical care. The local anesthetic type and dose used for the block will be recorded.
干预措施: Serratus posterior superior intercostal plane block (Procedure)
Control Group
Participants undergoing elective breast surgery who are included in the control cohort as determined by routine clinical care. Investigators do not assign participants to this cohort and perform postoperative follow-up only.
结局指标
主要结局
Cumulative Tramadol Consumption During the First 24 Hours After Surgery
时间窗: During the first 24 postoperative hours
The total amount of tramadol consumed through the patient-controlled analgesia device will be recorded in milligrams at postoperative hour 24.
次要结局
- Numeric Rating Scale Pain Score at Rest(At postoperative hours 0, 2, 4, 6, 12, and 24)
- Numeric Rating Scale Pain Score During Movement(At postoperative hours 0, 2, 4, 6, 12, and 24)
- Dermatomal Extent of Sensory Block Assessed by Pinprick(At postoperative hours 0, 2, 4, 6, 12, and 24)
- Incidence of Postoperative Nausea and Vomiting(During the first 24 postoperative hours)
- Incidence of Block-Related Complications(During the first 24 postoperative hours)
研究者
Korgün Ökmen
Professor of Anesthesiology and Reanimation
Bursa Yuksek Ihtisas Training and Research Hospital