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临床试验/NCT04565301
NCT04565301已完成不适用

A Comparative Study Between Neostigmine and Dexamethasone as an Adjuvant to Bupivacaine in Adductor Canal Block After Knee Arthroscopy Surgery

Cairo University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年6月20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
已完成
入组人数
90
试验地点
1
主要终点
first rescue analgesia time

研究概览

简要总结

To compare between the efficacy of neostigmine and dexamethasone as an adjuvant to bupivacaine in adductor canal block after knee arthroscopy surgery.

详细描述

90 participants in this study will be randomized into three groups based on computer generated numbers using computerized generated random tables. The patients enrolled in the study will be transferred to the operation room and monitored all through the surgical procedure using pulse oximeter, non-invasive blood pressure and ECG.

To perform spinal anesthesia ,the patient will be positioned in the sitting position then sterilization of the back using betadine solution 5% will be done then the iliac crest will be identified and the opposite intervertebral space(L4-L5) will be marked then 5 ml of lidocaine 2% will be infiltrated in the skin and subcutaneous tissue then a spinal needle (25G) will be introduced to the intrathecal space and after ensuring that clear cere¬brospinal fluid will be in free flow injection of 15-20mg of bupivacaine 0.5% and 25mcg of fentanyl will be administrated then the patient will be positioned in the supine position.

If hypotension, (decrease in the mean arterial blood pressure of more than 20%from base line) occurs, 9mg intravenous ephedrine will be given with 200ml bolus crystalloids. If bradycardia (heart rate below 50beat / minute) occurs, 0.5mg intravenous atropine will be given. After the surgical procedure the patients will be randomly allocated using computerized generated random tables in to three equal groups and the random numbers will be concealed in closed opaque envelopes which will be kept by the senior anesthesia staff, the three groups are:

  • Group neostigmine: The patients in this group will be administered 500 mcg neostigmine (1 ml) + 1 ml isotonic saline (22) as adjuvant to 20 ml bupivacaine 0.50 % in the adductor canal block.
  • Group dexamethasone: The patients in this group will be administered 8 mg dexamethasone (2 ml) (23) as adjuvant to 20 ml bupivacaine 0.50 % in the adductor canal block.
  • Group control: The patients in this group will be administered 2 ml isotonic saline + 20 ml bupivacaine 0.50 % in the adductor canal block (control group).

With the patient in the supine position, the procedural needle (Braun Stimuplex Ultra Insuflated Echogenic Needle 22G) will be inserted in plane from the anteromedial side at the mid thigh level. It will be advanced through the sartorius muscle and fascia under ultrasound guidance, using a Siemens Acuson X300 ultrasound equipped with a linear transducer after sterilization of the skin with betadine solution 5%, and the adductor canal, with the superficial femoral artery and vein within, will be identified. Once the needle tip will be located in the adductor canal, the anaesthetic solution will be injected anterior to the artery and deep into the sartorius muscle (24) then patient will be transferred to the PACU then to the ward.

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, Care Provider)

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

  • patients undergoing knee arthroscopy surgery.
  • Age between 18 years and 65 years.
  • Both sexes
  • ASA I & ASA II

排除标准

  • Patients' refusal
  • Allergy to any drug that will be used in the study
  • Psychological or mental disorders.
  • Disturbance of Conscious level.
  • Uncooperative patients
  • Coagulopathy
  • Contraindications to spinal anaesthesia (e.g.: severe mitral stenosis)

研究组 & 干预措施

Group C

Placebo Comparator

The patients in this group will be administered 2 ml isotonic saline + 20 ml bupivacaine 0.50 % in the adductor canal block (control group).

干预措施: NaCl solutions (Other)

Group D

Active Comparator

The patients in this group will be administered 8 mg dexamethasone (2 ml) (23) as adjuvant to 20 ml bupivacaine 0.50 % in the adductor canal block.

干预措施: Dexamethasone (Drug)

Group N

Active Comparator

The patients in this group will be administered 500 mcg neostigmine (1 ml) + 1 ml isotonic saline (22) as adjuvant to 20 ml bupivacaine 0.50 % in the adductor canal block.

干预措施: neostigmine (Drug)

结局指标

主要结局

first rescue analgesia time

时间窗: 24 hours

Time (in hours) of first rescue analgesia (morphine) requirement for each group in the first 24 hours following the adductor canal block

次要结局

  • morphine consumption(24 hours)
  • Presence of Nausea and vomiting(24 hours)
  • Visual analogue scale(up to 24 hours)
  • sensory block(up to 24 hours)

研究者

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

Heba Omar Ahmed

Associate professor of Anesthesia, pain management & surgical ICU

Cairo University

研究点 (1)

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Neostigmine and Dexamethasone in Adductor Canal Block | 临床试验