THE EFFECT OF ERECTOR SPINAE PLANE BLOCK PERFORMED IN ABDOMINAL HYSTERECTOMY ON ACUTE, CHRONIC POSTOPERATIVE, AND NEUROPATHIC PAIN: A RANDOMIZED CONTROLLED PROSPECTIVE STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Chronic postoperative pain severity at 6 months
研究概览
简要总结
This study evaluated whether bilateral erector spinae plane block (ESPB) performed before abdominal hysterectomy could reduce postoperative pain and the development of chronic and neuropathic pain. Adult patients undergoing abdominal hysterectomy under general anesthesia were assigned to receive either bilateral ESPB with bupivacaine or standard perioperative analgesic management without ESPB. Postoperative pain was assessed during the early postoperative period and at 1 and 6 months after surgery. Chronic and neuropathic pain were evaluated at 1 and 6 months using validated pain assessment tools.
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
- Single (Outcomes Assessor)
盲法说明
The postoperative outcomes assessor was blinded to group allocation. Participants, the anesthesiologist performing the intervention, and the care providers were not blinded because of the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years American Society of Anesthesiologists (ASA) physical status I-III Body mass index (BMI) <35 kg/m² Scheduled for elective total abdominal hysterectomy under general anesthesia Provided informed consent to participate in the study
排除标准
- •Decompensated heart failure Severe respiratory distress Renal failure Hepatic failure History of opioid addiction Current anticoagulant use or bleeding diathesis Refusal to participate in the study
研究组 & 干预措施
Control Group
Participants assigned to the control group received standard perioperative analgesic management without erector spinae plane block.
干预措施: Standard Perioperative Analgesia (Other)
ESPB Group
Participants assigned to the ESPB group received bilateral ultrasound-guided erector spinae plane block at the T8-T9 level before surgery, with 20 mL of 0.25% bupivacaine administered on each side, in addition to standard perioperative analgesic management.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Chronic postoperative pain severity at 6 months
时间窗: 6 months after surgery
Chronic postoperative pain severity was assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain imaginable).
次要结局
未报告次要终点
研究者
Merve Yusifov
Uzm.Dr.
Necmettin Erbakan University