跳至主要内容
临床试验/NCT05271331
NCT05271331招募中不适用

ESP Block Versus Wound Infiltration for Laminectomy: a Randomized Controlled Trial

University of Padova1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2022年5月23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
招募中
发起方
入组人数
112
试验地点
1
主要终点
Tramadol consumption

研究概览

简要总结

Spinal surgery is often burdened by perioperative pain and its treatment presently represents a challenge for anesthetists. An inadequate intra and postoperative analgesic therapy leads to a delay in the mobilization of the patients, prolonged hospital stay and thromboembolic complications, as well as the onset of chronic pain syndromes . Effective pain treatment can help improve surgical outcome for patients undergoing spinal surgery. From the pathophysiological point of view pain in vertebral surgery can originate from different anatomical structures: vertebrae, discs, ligaments, dura mater, facet joints, muscles and skin-subcutis. The terminal innervation of these tissues originate from the dorsal branches of the spinal nerves, and this represents a target a multimodal approach to perioperative analgesia in vertebral surgery. Systemically administered drugs such as NSAIDs, opioids, ketamine, intravenous lidocaine could benefit from the addition of locoregional therapies such as neuraxial blocks (anesthesia peridural or subarachnoid) or as shown more recently by other anesthesia techniques locoregional ultrasound-guided In recent years the anesthesiological interest has focused on the Erector Spinae Plane Block (ESPB). First described by Forero et al, it is a paraspinal interfascial block targeting the dorsal and ventral branches of the spinal nerves just after their emergence from the spinal cord. In the ultrasound-guided technique the local anesthetic is injected between the deep fascia of the muscle itself and the transverse processes of the vertebrae at the level interested. The aim of this study is to evaluate the efficacy of ESPB when compared to wound infiltration in patients undergoing laminectomy

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Both arms will receive the same treatment (Wound infiltration and ESP block) after general anesthesia induction (Participant masked to intervention) Drugs will be prepared after randomization by a physician not involved in the care of the patients and not involved in the study, and labelled as WOUND INFILTRATION and ESP block. One syringe will contain local anesthetic, the other normal saline (Care Provider masked to intervention, Investigator masked to intervention) Outcome assessor will be not involved in other part of the study and will be not aware of the intervention (Outcome assessor masked to intervention)

入排标准

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

入选标准

  • Planned 1 or 2 level surgical laminectomy

排除标准

  • Allergy to local anesthetics
  • Refusal of consent
  • Uncompensated cardiopathies, nephropathies, liver disease or peripheral neuropathies
  • Hemopathies that predispose to bleeding
  • Gastrointestinal ulcer or bleeding
  • Local infection
  • Psychiatric or neurological disorders (except those attributed to primary disease for which intervention is planned) History of abuse (or use in the 24 hours prior to surgery) Alcohol addiction ASA > 3

研究组 & 干预措施

ESP block

Experimental

Patient will receive ESP block one level above surgery with ropivacaine 0.35% 20 ml per side Patient will receive preoperative wound infiltration with Saline 40 ml

干预措施: Wound infiltration with saline (Drug)

ESP block

Experimental

Patient will receive ESP block one level above surgery with ropivacaine 0.35% 20 ml per side Patient will receive preoperative wound infiltration with Saline 40 ml

干预措施: ESP block with local anesthetic (Drug)

Wound infiltration

Active Comparator

Patient will receive ESP block one level above surgery with Saline 20 ml per side Patient will receive preoperative wound infiltration with ropivacaine 0.35% 40 ml

干预措施: ESP block with saline (Drug)

Wound infiltration

Active Comparator

Patient will receive ESP block one level above surgery with Saline 20 ml per side Patient will receive preoperative wound infiltration with ropivacaine 0.35% 40 ml

干预措施: Wound infiltration with local anesthetic (Drug)

结局指标

主要结局

Tramadol consumption

时间窗: Evaluated from extubation for the first post-operative 24 hours

Postoperative tramadol consumption

次要结局

  • Time to first analgesic requirement(24 hours after end of surgery)
  • Pain 0 hours(At extubation)
  • Pain 12 hours(12 hours after end of surgery)
  • Evaluation of patient satisfaction(24 hours after end of surgery)
  • Incidence of post operative motor block(24 hours after end of surgery)
  • Pain 6 hours(6 hours after end of surgery)
  • Pain 24 hours(24 hours after end of surgery)
  • Incidence of post operative nausea-vomiting(24 hours after end of surgery)
  • Incidence of post operative respiratory depression(24 hours after end of surgery)
  • Incidence of post operative pruritus(24 hours after end of surgery)
  • Intraoperative opioid consumption(At extubation)

研究者

发起方
University of Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Geraldini

Principal Investigator

University of Padova

研究点 (1)

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