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临床试验/NCT03650998
NCT03650998已完成4 期

Ultrasound-guided Transmuscular Quadratus Lumborum Block for Laparoscopic Hysterectomy. A Double Blind, Randomized, Placebo Controlled Trial.

Zealand University Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年9月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
70
试验地点
1
主要终点
Postoperative opioid consumption

研究概览

简要总结

Study is designed to assess the effect of the transmuscular quadratus lumborum block on postoperative opioid consumption and pain for patients undergoing laparoscopic hysterectomy. Study is randomized, placebo-controlled and blinded. Seventy patients will be included.

详细描述

Every year three hundred patients undergo hysterectomy at the department of obstetric and gynaecologic surgery at Zealand University Hospital, University of Copenhagen. The most common procedure is Total Laparoscopic Hysterectomy (TLH), which is the preferred technique in about four out of five hysterectomies at our facility. Multimodal analgesia consists of Paracetamol 1 g, Ibuprofen 400 mg and Dexamethasone 8 mg and Sufentanil 0.2 micrograms/kg for emergence if no contraindications are present. Standard general anaesthesia is total intravenous anaesthesia (TIVA) with an induction consisting of Remifentanil and Propofol infusions, a bolus of Propofol followed by muscle relaxation with Rocuronium. Patients are intubated in the trachea. Anaesthesia is maintained with Remifentanil and Propofol infusions and boluses of Rocuronium are administered whenever the surgeon requires it. Patients are always in Trendelenburg's position. Thirty minutes prior to emergence a bolus of Sufentanil 0.2 microg/kg is administered, as mentioned previously. Of interest: two other different opioid based regimens are currently used in the other two hospitals in Region Zealand where this procedure is performed. There is no national standards defined for dosages used for this kind of surgery. Additionally, no regional techniques are defined for this surgical procedure.

Our research group at Zealand University Hospital has conducted a thorough retrospective one-year survey for this patient group in order to define the quantity of the research problem. The electronic anaesthesia files, PACU files and ward files were meticulously reviewed. The survey revealed an accumulated morphine consumption in the first 12 postoperative hours of 44.1±30.8 mg of oral morphine equivalents in TLH patients. This dosage should be evaluated in relation to the standardized multimodal regimen described above.

Anaesthesiologists have primarily used either epidural catheters or long-lasting opioids as the basis for the postoperative pain management of expected or manifest moderate to severe pain. An epidural blockade can be contraindicated for some patients, and might cause bladder paralysis, lower extremity paralysis, hypotension etc. In addition, the epidural technique is labour-intensive in application as well as in its requirements for monitoring. Thus, the continuous epidural blockade is not a possibility of interest to the gynaecologists at our hospital. Therefore, until recently, opioids have been the sole treatment of pain, when over-the-counter medicine does not suffice. This presents a problem for the patients due to the well-known adverse effects of morphine including postoperative nausea and vomiting (PONV), itching, fatigue, constipation, confusion, respiratory depression and delayed mobilization.

Postoperative complications to surgery are more frequent in patients experiencing postoperative pain, and besides reducing the immediate postoperative pain perception, the investigators consider reduction of the total morphine consumption and the potential of reducing development of chronic pain through better treatment of the acute pain, as very interesting and promising for the patients in our study.

The investigators have the technical capability to improve perioperative pain management by taking advantage of USG peripheral nerve blocks (PNBs). The investigators' group of researchers have described the transmuscular quadratus lumborum (TQL) block and the mechanism by which the TQL block works has been proven in a major cadaveric study and some case reports.

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)

入排标准

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

入选标准

  • Scheduled for TLH
  • Age ≥ 18 years at the date of inclusion Have received thorough information, orally and in written, and signed the "Informed Consent" form on participation in the trial

排除标准

  • Inability to cooperate
  • Inability to speak, read and understand Danish
  • Allergy to local anaesthetics or opioids
  • Daily intake of opioids, according to the investigators decision
  • Local infection at the site of injection or systemic infection
  • Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration
  • Co-morbidity, ASA>3

研究组 & 干预措施

Active

Active Comparator

Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL ropivacaine 0.375% single shot.

In both arms morphine will be administered IV as part of a patient controlled analgesia PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.

干预措施: Ropivacaine (Drug)

Placebo

Placebo Comparator

Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL Saline single shot.

In both arms morphine will be administered IV as part of a patient controlled analgesia PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.

干预措施: Saline (Drug)

结局指标

主要结局

Postoperative opioid consumption

时间窗: Twelve hours postoperatively

How much cumulated opioid in oral morphine equivalents does the participant require/use.

次要结局

  • Postoperative pain intensity(12 hours.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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