Comparison of the Effects of Superior Hypogastric Plexus Block and Erector Spinae Plane Block on Postoperative Analgesia in Total Laparoscopic Hysterectomy Surgery
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
- Total Tramadol Consumption
研究概览
简要总结
Total laparoscopic hysterectomy (TLH) is one of the most commonly performed gynecological surgeries today. Various analgesic techniques are used for the management of postoperative pain. The aim of this study is to compare the postoperative analgesic efficacy of superior hypogastric plexus block (SHPB) and erector spinae plane block (ESPB) in patients undergoing TLH procedures.
详细描述
This prospective, randomized, double-blind, single-center clinical trial aims to compare the postoperative analgesic efficacy of Superior Hypogastric Plexus Block (SHPB) and Erector Spinae Plane Block (ESPB) in patients undergoing total laparoscopic hysterectomy (TLH).
Following ethics committee approval (2022/514/220/10), the study was conducted between March 2022 and March 2023. Patients aged 18 to 65 years, classified as ASA physical status I-II and scheduled for elective TLH, were enrolled. Participants were randomly assigned into three groups using computer-generated randomization (n=30 per group): SHPB, ESPB, and Control. Both the anesthesiologist performing postoperative evaluations and the patients were blinded to group allocation.
All patients received general anesthesia in accordance with a standardized protocol.
ESPB was performed bilaterally at the T10 level under ultrasound guidance. SHPB was performed laparoscopically at the L5-S1 level after uterine removal. No regional block was applied in the control group.
Postoperative pain management was provided to all patients via patient-controlled analgesia (PCA). Pain levels were evaluated using the Visual Analog Scale (VAS) at postoperative 0, 30, 60, 90, and 120 minutes, and at 6, 12, and 24 hours.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The study was conducted in a double-blind manner. Participants, care providers performing the block procedures, and outcome assessors were blinded to group assignments.
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
- •Female patients aged between 18 and 65 years
- •Scheduled for elective total laparoscopic hysterectomy (TLH)
- •Classified as American Society of Anesthesiologists (ASA) physical status I or II
- •Able to provide written informed consent in accordance with the Declaration of Helsinki
排除标准
- •Refusal to participate or inability to provide informed consent
- •Body mass index (BMI) ≥ 35 kg/m²
- •Inability to cooperate or follow instructions
- •Presence of spinal or paravertebral deformity
- •Known coagulopathy or use of anticoagulant therapy
- •Known hypersensitivity or allergy to local anesthetic drugs used in the study
- •Requirement for postoperative intensive care
- •History of chronic opioid use (longer than four weeks prior to surgery)
研究组 & 干预措施
Superior Hypogastric Plexus Block (SHPB) Group
SHPB Group: In this group, patients received a superior hypogastric plexus block (SHPB) following total laparoscopic hysterectomy. After uterus removal and vaginal cuff closure, and before trocar removal, the injection site was identified laparoscopically. The block was performed in all patients by a single surgeon experienced in SHPB.
干预措施: Superior Hypogastric Plexus Block (SHPB) (Procedure)
Erector Spinae Plane Block Group
ESPB Group: Patients in this group received erector spinae plane block (ESPB) during anesthesia maintenance after surgery. Patients were positioned in the lateral decubitus position. At the T10 level, the ultrasound probe was placed in the midline to identify spinous processes, then moved 2-3 cm laterally to visualize the transverse process, trapezius, and erector spinae muscles. The same procedure was performed on the opposite side. All blocks were performed by a single anesthesiologist experienced in ESPB.
干预措施: Erector Spinae Plane Block (ESPB) (Procedure)
Control Group
Control Group: Patients in this group did not receive any block and were managed with standard postoperative care only. This group served as the comparison group to evaluate the effects of the block interventions.
结局指标
主要结局
Total Tramadol Consumption
时间窗: Postoperative 0-24 hours
The total amount of tramadol administered via a patient-controlled analgesia (PCA) device within the first 24 hours after total laparoscopic hysterectomy. This measurement is used to compare the postoperative analgesic efficacy of superior hypogastric plexus block (SHPB) and erector spinae plane block (ESPB) with the control group receiving no block. Tramadol consumption is recorded in milligrams (mg) and extracted directly from PCA device logs.
次要结局
- Postoperative Pain Intensity (VAS Scores)(Postoperative 0-24 hours)
- Time to First Rescue Analgesia(Postoperative 0-24 hours)
- Postoperative Pain Intensity (VAS Scores)(Postoperative 0-24 hours)
- Time to First Rescue Analgesia(Postoperative 0-24 hours)
- Incidence of Postoperative Nausea and Vomiting (PONV)(Postoperative 0-24 hours)
研究者
MACİD ORDU
Assistant Doctor
Dr. Lutfi Kirdar Kartal Training and Research Hospital