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临床试验/NCT06728046
NCT06728046尚未招募不适用

Analgesic Effects of Ultrasound-Guided Erector Spinae Plane Block v.s Patient Controlled Analgesia in Correction Surgery for Idiopathic Scoliosis: A Randomized Controlled Trial

West China Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Resting numerical rating scale (NRS) pain scores

研究概览

简要总结

Scoliosis correction surgery involves extensive surgical wounds, intense intraoperative stimulation, and severe postoperative pain, often necessitating the use of potent opioids. However, there is a critical clinical need for effective pain management strategies that both ensure sufficient analgesia and minimize opioid-related adverse effects. The Erector Spinae Plane Block (ESPB) has shown promise as an effective analgesic technique, but its application in scoliosis correction surgery has not been reported.We hypothesize that ESPB provides superior postoperative analgesia compared to patient-controlled intravenous analgesia (PCA) pumps. Specifically, ESPB is expected to significantly reduce postoperative pain scores, decrease perioperative opioid consumption, and mitigate opioid-related side effects.

This study is a randomized controlled trial involving 40 participants undergoing scoliosis correction surgery, randomized into two groups: the ESPB group and the PCA group. The primary outcome measure is the resting pain score at 2 hours postoperatively, which will be used to evaluate the efficacy of ESPB. Secondary outcomes include perioperative opioid consumption and the incidence of opioid-related adverse effects. The study aims to provide evidence for ESPB as an innovative and effective method for postoperative analgesia in scoliosis correction surgery.

详细描述

Scoliosis correction surgery involves large surgical wounds spanning multiple vertebrae, requiring sufficient analgesia to manage intense intraoperative stimulation and severe postoperative pain. Effective pain control in this context often necessitates potent opioids, such as morphine or equivalent drugs. Current perioperative analgesia strategies include intraoperative use of long-acting opioids (e.g., sufentanil, fentanyl) and patient-controlled analgesia (PCA) pumps for postoperative pain management, primarily involving opioids like sufentanil or morphine. However, opioids are associated with adverse effects such as nausea, vomiting, bowel obstruction, pruritus, dizziness, respiratory depression, opioid tolerance, and hyperalgesia, which can lead to suboptimal pain control and negatively impact patients' quality of life and postoperative recovery. There is a critical need for effective analgesic methods in scoliosis correction surgery that minimize opioid-related adverse effects, enhance the patient experience, and promote accelerated recovery.

The Erector Spinae Plane Block (ESPB) was first reported by Forero et al. in 2016 as an effective analgesic technique for rib-related neuropathic pain. Its mechanism involves the injection of local anesthetics into the fascial plane between the erector spinae muscle and the transverse process, allowing for the diffusion of the anesthetic to adjacent areas. ESPB exerts its primary analgesic effect through the posterior branches of spinal nerves and can further diffuse anteriorly to paravertebral and epidural spaces, and laterally across the costotransverse foramina, affecting nerve roots and visceral structures. This mechanism provides comprehensive analgesia. ESPB has since been widely applied in perioperative pain management for thoracic surgery, shoulder arthroscopy, breast surgery, abdominal surgery, cesarean sections, and urological procedures, as well as for acute and chronic pain conditions such as rib fractures, postherpetic neuralgia, burns, and cancer pain.

Studies have demonstrated that ESPB effectively reduces postoperative pain scores, decreases opioid consumption, delays the need for rescue analgesics, reduces the number of patients requiring rescue medication, and lowers the incidence of nausea and vomiting in spinal surgeries. Although there are limited case reports and clinical experience summarizing its perioperative analgesic effect in scoliosis correction surgery, preliminary findings suggest it is effective.

Based on the analgesic mechanism of ESPB and prior studies, we hypothesize that ESPB provides superior postoperative pain control compared to PCA, significantly reducing postoperative pain scores, perioperative opioid consumption, and associated adverse effects.

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

Due to differences in clinical management between the groups, investigators, participants, and clinical staff will be aware of group assignments. However, follow-up researchers and statisticians responsible for data analysis will remain blinded to the group assignments.

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 14 years or older, regardless of gender.
  • Scheduled for scoliosis correction surgery.
  • Signed informed consent from the participant or their legal guardian.

排除标准

  • Allergy to local anesthetics such as ropivacaine.
  • Family history of malignant hyperthermia.
  • Severe systemic diseases affecting the heart, lungs, liver, or kidneys.
  • Neurological or psychiatric disorders.
  • Communication difficulties, such as hearing impairment or speech disorders.
  • Concurrent participation in other clinical studies.
  • Other conditions deemed unsuitable for participation by the investigators.

结局指标

主要结局

Resting numerical rating scale (NRS) pain scores

时间窗: 2 hours postoperatively

The Numerical Rating Scale (NRS) is a tool for assessing pain intensity, allowing patients to rate their pain on a scale from 0 to 10, where 0 represents "no pain," 10 represents "the worst pain imaginable," and pain levels are categorized as 0 (no pain), 1-3 (mild pain), 4-6 (moderate pain), and 7-10 (severe pain).

次要结局

  • Severe complications(30 days postoperatively)
  • Postoperative resting NRS pain scores(3 days after surgery)
  • Postoperative NRS pain scores during movement(3 days after surgery)
  • Postoperative opioids consumption(30 days postoperatively)
  • Time to initiate functional exercises(30 days postoperatively)
  • Total length of hospital stay(7 days after discharge)
  • Postoperative length of hospital stay(7 days after discharge)
  • Total hospital cost(7 days after discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ren Liao

Professor

West China Hospital

研究点 (1)

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