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临床试验/NCT02463370
NCT02463370已完成不适用

Effectiveness of Four Versus Ten Local Anesthetic Injections for Post-submucosal Resection Pain Relief: a Randomized, Double Blinded Clinical Trial

Makassed General Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Change in postoperative pain over ten days measured by the Numeric Rating Scale

研究概览

简要总结

Submucosal resection of the nasal septum (SMR) could be performed under local anesthetic infiltration performed through ten injections in addition to general anesthesia which was associated with less postoperative pain and shorter hospital stay.

However, the local infiltration technique is time-consuming and requires a large number of facial injections. This gave rise to the idea of reducing the number of injections while retaining the effectiveness of the local anesthetic technique.

Decreasing the number of injections could be achieved by blocking the superior maxillary nerve (V2) and the infra-orbital nerve since it would result in anesthetizing the surgical area as well after induction of general anesthesia.

The purpose of this prospective double-blind clinical trial was to compare the effectiveness of four versus ten local anesthetic injections in terms of postoperative pain relief. The secondary objective was to compare patients' and surgeons' satisfaction between the two techniques.

详细描述

Informed consent will be obtained from patients (ASA I and II) scheduled to undergo elective submucosal resection of the nasal septum between May and November 2015.

The sealed envelope technique is used to randomly assign patients into two groups. The anesthetists, surgeons, and nurses who collected the will be blinded to the study groups. Patients in both groups will receive general anesthesia and six injections on each side of the face at the following points: suprazygomatic maxillary (V2) area, infra-orbital area, supratrochlear area, medial to the medial canthus, nasal still and anterior septum. Group II patients will receive local anesthetic infiltration in two injections on each side of the face at the maxillary and infra-orbital areas and the remaining injections are placebo (saline). Group V patients will receive local anesthesia in five injections on each side of the face at the infra-orbital area, supratrochlear area, medial to the medial canthus, nasal still and anterior septum. The remaining maxillary injection is placebo.

To maintain double-blindness, three syringes (one 5 ml and two 10 ml) will be used for the six injections. They are prepared by a nurse who is not involved in the study. The 5 ml syringe (Becton Dickinson, Franklin Lakes New Jersey, USA) is labeled "F" indicating that it should be used at the infra-orbital area for both groups. The total injected solution is about 2 ml. One of the 10 ml syringes (Becton Dickinson, Franklin Lakes New Jersey, USA) is labeled "I" indicating that it should be used for infiltration at the supratrochlear area, medial to the medial canthus, nasal still and anterior septum. The total injected solution is 6 ml. The second 10 ml syringe is labeled "Z" to be used for the suprazygomatic maxillary nerve block.

The syringe labeled "F" always contains the local anesthetic solution. When syringe "I" contains the anesthetic mixture (group V), then syringe "Z" is placebo. In contrary, when syringe "Z" contains the anesthetic solution (group II), syringe "I" is placebo. The local anesthetic mixture is composed of 3 ml lidocaine 2%, 3 ml bupivacaine 0.5%, and 1 ml fentanyl 50 µg/ml. In addition, syringe "F" contains 50 µg clonidine while syringes "I" and "Z" have 100 µg clonidine (when they contain the anesthetic solution).

  • Suprazygomatic maxillary nerve block technique:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 15 years and older

排除标准

  • Patients younger than 15 years old or have the following: a history of allergy to local anesthetics, suspected malignant neoplasm, BMI>40 kg/m2, hemodynamic instability or infection at the site of injection.
  • Patients whom it will not be possible to follow them through telephone calls will also be excluded.

结局指标

主要结局

Change in postoperative pain over ten days measured by the Numeric Rating Scale

时间窗: First postoperative day every six hours (at 0, 6 and 12 hours) and after that once daily for the next nine days

Numeric Rating Scale will be used to measure postoperative pain

次要结局

  • Surgeons' satisfaction(Surgeons' satisfaction intraoperatively and postoperatively)
  • Patients' satisfaction(Patients' satisfaction at 0, 6 and 12 hours postoperatively.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zoher Naja

Chairperson of Anesthesia and Pain Management Department

Makassed General Hospital

研究点 (1)

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