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临床试验/NCT03967314
NCT03967314已完成不适用

A Comparison of Ultrasound-Guided Modified-Thoracolumbar Interfacial Plane Block and Wound Infiltration for Postoperative Pain Management in Lumbar Spinal Surgery Patients

Medipol University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

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
Opioid consumption by the patients at postoperative 24 hours period

研究概览

简要总结

Pain management is an important issue following lumbar spinal surgery. Wound infiltration is a technique that a local anesthetic solution is infiltrated into the tissues around the surgical area. Modified thoracolumbar interfacial plane (mTLIP) block was described by Ahiskalioglu et al. In this study, the investigators aimed to compare the analgesic efficacy of the US-guided mTLIP block and wound infiltration following lumbar disc surgery.

详细描述

Spinal surgery in the lumbar region is one of the most common surgeries performed for leg and back pain. Postlumbar surgery pain can be severe and may progress to chronic pain during the postoperative period. Therefore, pain management is important after lumbar spinal surgery. Effective postoperative pain management enables early mobilization and shorter durations of hospital stays and may also reduce hospitalization-related complications, such as infections and thromboembolism.

There are a variety of techniques for postoperative pain management. These include intravenous-intramuscular injections, patient-controlled analgesia devices, local anesthetic infiltration, and regional anesthesia. Among these techniques, intramuscular and intravenous (IV) injections may be ineffective in pain management, as they are generally administered after the pain has commenced. In addition, intermittent treatment with analgesic agents may not result in a therapeutic level in the blood.

The most common analgesic agents used postoperatively are opioids. However, parenteral opioids may result in undesirable adverse events, such as nausea, vomiting, itching, sedation, and respiratory depression. Various methods are available to reduce the use of systemic opioids in postoperative pain management, one of which is local anesthetic infiltration (wound infiltration) into the operation site. Several studies reported that wound infiltration can reduce opioid consumption following surgery. Various regional anesthesia techniques can also be used to manage postoperative pain. Such techniques have a high success rate, especially if they are applied with ultrasound (US) guidance, as US improves visualization, thereby reducing potential complications. Previous research reported that US-guided modified thoracolumbar interfacial plane (mTLIP) block after lumbar spinal surgery via a lateral approach provided effective analgesia. No studies seem to have compared the analgesic effectiveness of wound infiltration versus TLIP block. In this study, the investigators compared the analgesic efficacy of the US-guided mTLIP block and wound infiltration following lumbar disc surgery. The primary aim was to compare postoperative opioid consumption. The secondary aim was to evaluate postoperative pain scores and adverse effects of opioids, such as allergic reactions, nausea, and vomiting.

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 (Participant, Outcomes Assessor)

盲法说明

Outcomes Assessor and participant were blinded to 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

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for lumbar discectomy/hemilaminectomy surgery under general anesthesia

排除标准

  • Bleeding diathesis
  • Receiving anticoagulant treatment
  • Known local anesthetics and opioid allergy
  • Infection of the skin at the site of the needle puncture
  • Pregnancy or lactation
  • Patients who do not accept the procedure

研究组 & 干预措施

Group T = TLIP block group

Active Comparator

After the induction of anesthesia and placement of the patient in a prone position, US-guided mTLIP block was performed via the lateral approach in group T. For postoperative analgesia, a dose of 1 g of paracetamol (IV) was administered routinely, every 8 h. All the patients received fentanyl via a patient-controlled analgesia device. The protocol was a 20 mcg bolus without an infusion dose, 20-min lockout time, and 4-h limit

干预措施: TLIP block group (group T) (Other)

Group W = Wound infiltration group

Active Comparator

After the induction of anesthesia and placement of the patient in a prone position wound infiltration was performed in group W. For postoperative analgesia, a dose of 1 g of paracetamol (IV) was administered routinely, every 8 h. All the patients received fentanyl via a patient-controlled analgesia device. The protocol was a 20 mcg bolus without an infusion dose, 20-min lockout time, and 4-h limit

干预措施: Wound infiltration group (group W) (Other)

结局指标

主要结局

Opioid consumption by the patients at postoperative 24 hours period

时间窗: Postoperative 24 hours

Fentanyl using

次要结局

  • Postoperative pain scores(Postoperative 24 hours period)

研究者

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

Bahadir Ciftci

Primary researcher

Medipol University

研究点 (2)

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