跳至主要内容
临床试验/NCT05680142
NCT05680142已完成不适用

Efficacy of Cervical Erector Spina Plane Block and Superficial Cervical Plexus Block in Anterior Cervical Disc and Fusion Surgery

Başakşehir Çam & Sakura City Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Qualitif of Recovery-15 (QoR-15)

研究概览

简要总结

Erector Spina Plane (ESP) block has been widely used in recent years, and it is also used in the control of postoperative analgesia in many types of surgery due to its proximity to the central area and its wide spread feature. In this study, the investigators aimed to demonstrate the effectiveness of ESP block on postoperative pain management in anterior cervical disc and fusion surgeries.

详细描述

This study includes ASA I-II patients aged 18-65 years who will undergo Anterior Cervical Disc and Fusion Surgery at C5 or C6 level under general anesthesia under elective conditions. In the preoperative period, the participant groups will be divided into two separate groups, Group cESP and Group sCPB, according to the type of block applied.

Groups will be compared according to demographic data, duration of surgery, perioperative drug consumption, postoperative pain scores, additional analgesic requirement and presence of shoulder pain. The blocks will be applied with the help of an 8-12 mHz linear probe after the patients are determined by the closed envelope method. In group cESP, block will be applied using in-plane technique at the level of C6 or C7 transverse vertebral corpus in the fascia between the semispinalis capitis muscle and the posterior scalene muscle. During the block, a total of 20 mL volume of 0.25% bupivacaine concentration will be given bilaterally to all patients. Group sCPB will be administered using 10 mL of 0.25% bupivacaine by entering from the C4 level from the right side of the neck from the posterior side of the sternocleidomastoid muscle. It was planned to routinely administer 10 mg/kg paracetamol and 2x10 mg tenoxicam iv to all patients for postoperative pain control. Patients will be taken to the recovery unit in the postoperative period, where their analgesic needs, frequency of nausea-vomiting, VAS scores, and additional problems will be followed up by the nurse who was included in the study blindly. After 1 hour of follow-up in the Recovery Unit, the participants will be directed to the service. The participants' VAS scores and additional analgesic needs will be recorded at 6, 12, and 24 hours postoperatively.

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 (Care Provider, Outcomes Assessor)

盲法说明

After the block, another anesthetist who did not know which group the patient belonged to was included in the study blindly. The patients were taken to the recovery unit in the postoperative period, and their analgesic needs, frequency of nausea and vomiting, VAS scores and additional problems were followed up by the nurse who was blindly included in the study.

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

入选标准

  • ASA (American Society of Anesthesiologists) Classification I-II
  • Anterior Cervical Disc and Fusion Surgery

排除标准

  • Patients with bleeding diathesis
  • Neurological disease,
  • BMI (Body Mass Index) less than 19 or greater than 30
  • The presence of infection in the neck area
  • Patients who do not accept the procedure

研究组 & 干预措施

Group sCPB

Active Comparator

Superficial cervical plexus block, patients who applied sCPB for postoperative pain

干预措施: superficial cervical plexus block (Drug)

Group cESP

Active Comparator

Cervical erector spinae plane block, patients who applied cervical ESP block for postoperative pain

干预措施: cervical erector spinae plane block (Drug)

结局指标

主要结局

Qualitif of Recovery-15 (QoR-15)

时间窗: Postoperative 24th hour

The QoR-15 scale is a unidimensional measurement of quality of recovery measured in five domains: physical comfort, pain, physical independence, psychological support, and emotional state. The QoR-15 scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery

VAS (Visual Analog Scala) score

时间窗: Postoperative 24th hour

The patients were followed up with a VAS score between 0-10 in the postoperative period. A VAS score of 0 was defined as no pain, and 10 as the most severe pain imaginable.

次要结局

  • Analgesic consumption(Postoperative 24th hour)
  • Chronic Pain(1 month after surgery)
  • Postoperative nausea and vomiting(Postoperative 24th hour)

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

Ergün Mendeş

Specialist Doctor

Başakşehir Çam & Sakura City Hospital

研究点 (1)

Loading locations...

相似试验