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临床试验/NCT04898920
NCT04898920已完成不适用

The Effect of Pre-emptive Dexamethasone on the Postoperative Analgesia After Total Hip Arthroplasty: Randomized Controlled Study

Tanta University1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2021年5月23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
83
试验地点
1
主要终点
Postoperative morphine consumption

研究概览

简要总结

  • Certain studies suggested that preoperative administration of systemic glucocorticoids in patients undergoing hip or knee arthroplasty surgery may improve the postoperative analgesia owing to their anti-inflammatory effect.

  • This study will be carried out on 70 adult patients aged 21 to 75 years admitted to orthopedic operating rooms in Tanta university hospitals for hip surgery under spinal anesthesia. Informed written consent will be obtained from each participant.

  • Patients will be randomly distributed into two equal groups using the computer-generated software.

  • Control Group: (35 patients) Those patients will receive 10 ml of normal saline before surgery.

  • Dexamethasone Group: (35 patients) Those patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery.

  • Primary outcome will be postoperative morphine consumption and the secondary outcome will be the postoperative pain score

详细描述

  • This randomized controlled prospective study will be carried out on 70 adult patients aged 21 to 75 years admitted to orthopedic operating rooms in Tanta University Hospital for hip surgery under spinal anesthesia. I

Patients will be randomly distributed into two equal groups using the computer-generated software. An anesthesia resident who will be blinded to the study groups and not participating in it will help in the preparation of uniform 10-ml syringes that contain normal saline in the control group and 16 mg dexamethasone in the other group.

  • Control Group: (35 patients) Those patients will receive 10 ml of normal saline before surgery.
  • Dexamethasone Group: (35 patients) Those patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery.

All the patients will undergo standardized preoperative assessment consisted of history taking, general and regional examination, and requesting preoperative investigations including (complete blood count (CBC), coagulation profile, and renal function tests). Upon patient admission to the operating theater, they will be attached to a monitor consisting of pulse oximetry, 5 lead ECG, non-invasive blood pressure, end-tidal carbon dioxide (Co2), and temperature. Then, intravenous access will be established through the insertion of an 18-gauge peripheral venous cannula, then, lactated ringer solution 7ml/kg over 30 minutes will be started. All the equipment required for spinal anesthesia, general anesthesia, and nerve block will be prepared by an expert anesthesiologist who will not be participating in this research. Also, the resuscitation equipment will be prepared before starting anesthesia.

Under complete aseptic precautions and local anesthetic skin infiltration with 3 ml lidocaine 1% at L3-L4 or L4-L5 intervertebral space, midline approach spinal anesthesia will be performed using a 25 G spinal needle. Once intrathecal placement will be confirmed, a mixture of 2 ml of hyperbaric bupivacaine (10 mg) and 0.5 ml of fentanyl (25 ugs) will be injected. The patient will be monitored for the hemodynamic parameters including the heart rate and the mean arterial pressure every 3 minutes. Moreover, the sensory and motor blockade will be assessed.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

  • An anesthesia resident who will be blinded to the study groups and not participating in it will help in the preparation of uniform 10-ml syringes that contain normal saline in the control group and 16 mg dexamethasone in the other group to make the patient and care provider blinded to the group of the patient.
  • An assistant nurse who will be blinded to the study groups and will have no subsequent rule in it will help in the collection of the data of measurements to make the outcomes assessor blinded to the group of the patient.

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ASA II and III, aged 21 to 75 years, admitted for hip arthroplasty surgery

排除标准

  • Patients who refused to participate in the research
  • Suspected or diagnosed coagulopathy
  • Allergy to bupivacaine
  • With major cardiac, renal, or hepatic disorders

研究组 & 干预措施

Control Group

Placebo Comparator

The patients will receive 10 ml of normal saline as a placebo dexamethasone before surgery.

干预措施: Normal saline (Drug)

Dexamethasone Group

Experimental

Those patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery.

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Postoperative morphine consumption

时间窗: The first postoperative day

The total dose of morphine in mg consumed in the first 24 hours after surgery

次要结局

  • Postoperative pain score(The first postoperative day)

研究者

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

Sameh Abdelkhalik Ahmed Ismaiel

Dr

Tanta University

研究点 (1)

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