Effect of Preoperative Erector Spinae Plane Block on Recovery Quality, Time to Return to Daily Activities, and Postoperative Pain Scores in Inguinal Hernia Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Quality of Recovery
研究概览
简要总结
This study aims to evaluate the effect of the erector spinae plane block (ESPB), performed after surgery, on quality of recovery, postoperative pain, and time to return to daily activities in patients undergoing open inguinal hernia repair under spinal anesthesia.
Postoperative pain following inguinal hernia surgery may delay recovery and negatively affect patients' return to normal daily life. Although ESPB has been widely used as an effective analgesic technique in various surgical procedures, its effectiveness in inguinal hernia repair remains limited and not well established.
In this randomized controlled study, patients will be divided into two groups: one group will receive ESPB after surgery, while the control group will not receive any block. All patients will receive standard postoperative analgesia.
Quality of recovery, acute pain scores, and analgesic consumption will be assessed within the first 24 hours after surgery, and return to daily activities will be evaluated 30 days after surgery.
The primary outcome of this study is quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire. QoR-15 scores range from 0 to 150, with higher scores indicating better recovery. Scores will be recorded preoperatively and 24 hours after surgery.
Secondary outcomes include postoperative pain intensity, total opioid consumption, and time to return to daily activities. Pain intensity will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, at 15, 30, 60, and 120 minutes, as well as 6, 12, and 24 hours after surgery.
Total opioid consumption will be determined by recording the cumulative dose of intravenous tramadol administered as rescue analgesia within the first 24 hours after surgery. Time to return to daily activities will be evaluated via telephone follow-up 15 days after surgery.
详细描述
This prospective, randomized, controlled study is designed to evaluate the effect of erector spinae plane block (ESPB) on postoperative recovery in patients undergoing open inguinal hernia repair under spinal anesthesia.
After obtaining written informed consent, eligible patients aged 18-65 years will be enrolled. Standard monitoring, including electrocardiography, non-invasive blood pressure, and peripheral oxygen saturation, will be applied upon arrival in the operating room. An intravenous line will be established, and isotonic saline infusion (15 mL/kg/h) will be initiated. Sedation will be provided with intravenous midazolam (0.03 mg/kg).
Spinal anesthesia will be performed at the L3-L4 interspace using 13 mg hyperbaric bupivacaine combined with 15 µg fentanyl.
At the end of surgery, patients will be randomized into two groups using a computer-generated randomization list prepared by an independent statistician. Group allocation will be concealed in sealed opaque envelopes and revealed to the anesthesiologist performing the intervention.
In the ESPB group, an ultrasound-guided erector spinae plane block will be performed at the T11-T12 level on the side of surgery. Patients will be positioned in the lateral decubitus position. After sterile preparation, a 2-5 MHz convex ultrasound probe (Fujifilm Sonosite, USA) will be placed in a paramedian sagittal orientation and then shifted laterally to visualize the transverse process and erector spinae muscle. A 22-gauge, 100-mm needle will be advanced using an in-plane technique, and 30 mL of 0.25% bupivacaine will be injected into the fascial plane between the transverse process and erector spinae muscle.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 65 years
- •Patients scheduled to undergo open IHT surgery under spinal anesthesia (unilateral)
- •Both male and female patients
排除标准
- •Patients with coagulation disorders
- •Patients with chronic opioid use
- •Patients who develop intraoperative complications
- •Patients with a preoperative Numeric Rating Scale (NRS) pain score ≥4
- •Patients with a history of revision (recurrent) surgery
- •Patients unable to communicate for any reason
- •Patients who decline to participate in the study
研究组 & 干预措施
Control Group
Patients will receive standard postoperative analgesia without any regional block.
ESPB Group
Patients will receive ultrasound-guided erector spinae plane block (ESPB) after surgery in addition to standard analgesia.
干预措施: Erector Spinae Plane Block (ESPB) group (Procedure)
结局指标
主要结局
Quality of Recovery
时间窗: Preoperatively and 24 hours after surgery
The Quality of Recovery-15 (QoR-15) is a validated questionnaire assessing postoperative recovery. The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
次要结局
- Postoperative Acute Pain Scores(15 minutes, 30 minutes, 60 minutes, and 120 minutes, as well as 6 hours, 12 hours, and 24 hours after surgery)
- Total Opioid Consumption(Within the first 24 hours after surgery)
- Time to return to daily activities(30 days after surgery)
- Duration of spinal anesthesia(From intrathecal injection to regression of sensory block within the first 24 hours after surgery)
- Motor block level assessed using the Bromage Scale(During the intraoperative period and within the first 24 hours after surgery)
- Sensory block level (dermatome level)(During the intraoperative period and within the first 24 hours after surgery)
研究者
Tolga Karaçay
Medical Doctor
Sanliurfa Education and Research Hospital