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临床试验/NCT03973398
NCT03973398Unknown早期 1 期

1.1 English Title of Research Project: Comparing the Efficacy of Ultrasound Guided Quadratus Lumborum Block Anterior Subcostal Versus Posterior Approach in Managing Postoperative Pain in Patients Undergoing Nephrectomy Surger: A Prospective Randomized Controlled Double Blinded Study

Sherif Mahmoud Mohammed Bekhet0 个研究点目标入组 120 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
早期 1 期
发起方
入组人数
120
主要终点
Comparing the analgesic effects of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by using the Revised American Pain Society Patient Outcome Questionnaire.

研究概览

简要总结

  • Primary outcome: to compare the efficacy of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block.
  • Secondary outcome: to evaluate the efficacy of Quadratus Lumborum Block in the control of postoperative pain in patients undergoing Nephrectomy surgery, hemodynamics, any complications and patients' satisfaction..

详细描述

A variant of the ultrasound-guided transversus abdominis plane (TAP) block was first described in an abstract, in which local anesthetic injection occurs at the point where the internal oblique and transversus abdominis muscles taper off and adjoin the lateral border of quadratus lumborum (QL) muscle.

Currently, the QL block is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery.

However, there is large disagreement regarding the best approach for administering the block because of unclear mechanisms responsible for the effects and complicated nomenclature system. Nephrectomy for patients with renal cell carcinoma (RCC) was first described in 1969. Surgical treatment varies with the pathology. Simple nephrectomy is the preferred option for those with non-neoplastic disease (e.g. trauma, non-functioning kidney with chronic infection) with radical nephrectomy being preferred in those with neoplastic disease. Radical nephrectomy implies resection of the whole of Gerota's fascia, including the perinephric fat, lymphatics, and the ipsilateral adrenal gland. Here the investigators are going to compare the Anterior (subcostal) approach to the Posterior approach to determine their level of spread and their value in controlling postoperative pain in patients scheduled for Nephrectomy surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-60 years.
  • ASA I and II
  • Elective surgery

排除标准

  • Patient's refusal.
  • Allergy to local anesthetics.
  • Peripheral neuropathy.
  • Bleeding diathesis.
  • Inflammation or infection over injection site.
  • Morbid obesity.
  • Patients on previous opioid therapy.
  • Psychiatric disorders.
  • Emergency surgery

结局指标

主要结局

Comparing the analgesic effects of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by using the Revised American Pain Society Patient Outcome Questionnaire.

时间窗: baseline

to compare the efficacy of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by the Revised American Pain Society Patient Outcome Questionnaire which is a set of questions answered by the patient to evaluate the patient's satisfaction and for quality improvement of pain management in hospitalized patients

Comparing the analgesic effects of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by using the Numeric Rating Scale.

时间窗: baseline

: to compare the efficacy of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by The Numeric rating scale (NRS) both resting and ambulatory which measures pain as felt by the patient every two hours for the first 24 hours then every six hours for the second day. the Numeric rating scale is a scale from 0 to 10 with '0' being lowest pain or no pain and '10' is the worst pain felt.

次要结局

  • using the numeric rating scale to determine the effect of Quadratus Lumborum block in reducing the postoperative pain in patients undergoing nephrectomy surgery(baseline)

研究者

发起方
Sherif Mahmoud Mohammed Bekhet
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sherif Mahmoud Mohammed Bekhet

Principle investigator

Assiut University

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