跳至主要内容
临床试验/NCT07403734
NCT07403734进行中(未招募)不适用

Evaluation of the Efficacy of Bilateral Lumbar Erector Spinae Plane Block (ESPB) on Postoperative Analgesia, Early Mobilization, and Length of Hospital Stay in Patients Undergoing Lumbar Disc Herniation Repair Surgery

Başakşehir Çam & Sakura City Hospital1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
78
试验地点
1
主要终点
Change in Postoperative Pain Scores Using Numeric Rating Scale (NRS)

研究概览

简要总结

This prospective observational study aims to evaluate the efficacy of bilateral lumbar erector spinae plane (ESP) block in providing effective postoperative analgesia and its potential impact on early mobilization and length of hospital stay in patients undergoing surgical repair of lumbar disc herniation.

Regional anesthesia techniques, particularly erector spinae plane blocks, have become an integral component of multimodal analgesia strategies in postoperative pain management. The ESP block has demonstrated effective analgesia across a wide spectrum of thoracic and abdominal surgeries and is increasingly utilized due to its ease of application and safety profile. By implementing multimodal analgesic techniques, this study seeks to achieve effective pain control, reduce opioid consumption and associated complications, facilitate early mobilization, decrease hospital length of stay, and enhance patient comfort.

详细描述

With the increasing use of ultrasound in recent years and the advantages it brings, the application of regional anesthesia methods such as truncal and peripheral nerve blocks in postoperative pain management has become the most important part of multimodal analgesia strategies. Among regional techniques, the erector spinae plane block has been shown to provide effective analgesia after many types of surgery and is being used increasingly. The erector spinae plane block provides effective analgesia in a wide spectrum of thoracic and abdominal surgeries such as thoracotomy, cholecystectomy, and bariatric surgery, and at the same time, because it is an easy and safe block, it is finding an increasingly expanding place in daily practice in the treatment of chronic and acute pain. The use of multimodal techniques in postoperative analgesia management aims to provide effective analgesia, thereby reducing opioid consumption and related complications, ensuring early mobilization and shorter hospital stay, and increasing patient comfort.

Lumbar disc herniation repair surgery is associated with significant postoperative pain that can negatively impact patient recovery, mobilization, and overall satisfaction. Postoperative pain control has a significant impact on earlier ambulation, better functional recovery, and patient satisfaction. At the same time, optimal pain management is of great importance in contributing to the reduction of the duration of hospital stay and the risk of adverse events.

This study was planned to investigate whether the Erector Spinae Plane Block provides effective postoperative analgesia in patients undergoing lumbar disc herniation repair surgery, and whether it has a positive effect on early mobilization and hospital length of stay. The study aims to demonstrate the effectiveness of the ESP block in reducing postoperative pain, decreasing narcotic analgesic consumption and protecting patients from the side effects of narcotic analgesics, facilitating early mobilization of patients, shortening hospital stay duration, and increasing patient comfort.

Erector spinae plane block (ESPB) was first described by Forero et al. in 2016, with ultrasound-guided local anesthetic injection between the erector spinae muscle and the transverse process of the thoracic vertebra providing effective analgesia for thoracic neuropathic pain. Since then, the ESPB has been widely used for various surgical procedures and has demonstrated consistent efficacy. The mechanism of action involves the spread of local anesthetic to the dorsal and ventral rami of spinal nerves in the interfascial plane, providing extensive dermatomal coverage. For lumbar spine surgery, bilateral lumbar ESPB has shown promise in providing satisfactory postoperative analgesia.

Since the erector spinae plane block is applied to specific anatomical regions defined under ultrasound guidance by a single experienced anesthesiologist (who has performed this block at least 20 times) and the local anesthetic spread is visually monitored, major differences in block effectiveness between patients are not expected. The procedure will be performed with the patient in a sitting position, targeting the area between the L2-4 transverse process and the erector spinae muscle (anterior to the muscle), using 20 mL of 0.25% bupivacaine bilaterally with ultrasound guidance using a convex probe. The application is bilateral and a total of 40 ml of local anesthetic solution will be used. After the procedure, dermatomal mapping will be performed at 30 minutes using a hot-cold test to evaluate block effectiveness in all patients.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients
  • Age 18-70 years
  • Patients scheduled to undergo single-level lumbar disc herniation repair surgery
  • American Society of Anesthesiologists (ASA) physical status classification I, II, or III
  • Willing to participate in the study (voluntary participation)
  • Fully oriented and able to cooperate with study procedures

排除标准

  • ASA physical status classification > III
  • Patients who refuse to participate in the study
  • Age < 18 years or > 70 years
  • Active infection at the site of block procedure
  • Previous lumbar disc herniation surgery
  • Chronic pain condition with continuous analgesic use
  • Coagulopathy or bleeding disorders
  • Patients unable to cooperate with postoperative pain assessments
  • Known allergy to local anesthetic agents
  • Body Mass Index (BMI) > 35 kg/m²
  • Renal insufficiency
  • Hepatic insufficiency

研究组 & 干预措施

ESP Block Group

Patients undergoing single-level lumbar disc herniation repair surgery who receive bilateral lumbar erector spinae plane block with 0.25% bupivacaine (20 ml per side, total 40 ml) under ultrasound guidance 30 minutes prior to anesthesia induction, in addition to standardized general anesthesia and postoperative patient-controlled analgesia.

Control Group (No Block)

Patients undergoing single-level lumbar disc herniation repair surgery who receive standardized general anesthesia and postoperative patient-controlled analgesia without erector spinae plane block.

结局指标

主要结局

Change in Postoperative Pain Scores Using Numeric Rating Scale (NRS)

时间窗: Assessed at 0, 15, 30, 60 minutes in the recovery unit and at 2, 6, 12, and 24 hours postoperatively on the ward (total assessment period: 24 hours)

Pain intensity will be measured using the 11-point Numeric Rating Scale (NRS: 0-10), where 0 represents "no pain" and 10 represents "worst pain imaginable." Pain scores will be assessed in three conditions: at rest, during deep breathing, and during coughing. The primary analysis will focus on pain scores at rest during the first 24 hours postoperatively.

次要结局

  • Total Opioid (Tramadol) Consumption(24 hours postoperatively)
  • Time to First Analgesic Request(From recovery unit arrival (0 minutes) up to 24 hours postoperatively)
  • Number of Analgesic Demands(24 hours postoperatively)
  • Need for Rescue Analgesia(24 hours postoperatively)
  • Incidence and Severity of Postoperative Nausea and Vomiting (PONV)(24 hours postoperatively)
  • Patient Satisfaction Score(24 hours postoperatively)
  • Time to First Mobilization(From end of surgery up to 48 hours postoperatively)
  • Hospital Length of Stay(From surgery date until hospital discharge, assessed up to 7 days)
  • Block Efficacy Assessment(30 minutes after ESP block administration (preoperatively))

研究者

发起方
Başakşehir Çam & Sakura City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Muzaffer GENCER

Associate Professor Doctor

Başakşehir Çam & Sakura City Hospital

研究点 (1)

Loading locations...

相似试验