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临床试验/NCT04776369
NCT04776369Unknown4 期

Effect of Intravenous Single-bolus Lidocaine Infusion Versus Intravenous Single-bolus Magnesium Sulfate Infusion on Postoperative Pain, Emotional Status and Quality of Life in Patients Undergoing Spine Fusion Surgery

Haitham Mohammad Ahmad Mohammad1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
60
试验地点
1
主要终点
short-term postoperative pain control

研究概览

简要总结

The goal in this work is to compare the effect of intravenous single-bolus lidocaine infusion versus intravenous single-bolus magnesium sulfate infusion on postoperative pain, emotional status and quality of life in patients undergoing spine fusion surgery.

详细描述

This is a double-blinded prospective controlled randomized clinical trial that will be performed in Assiut university hospital.

After obtaining approval from Assiut University Hospital Ethical Committee and informed written consent from patients, this study will be conducted on ASA status I, II and III patients, aged between 18y and 60 y, both male and female, undergoing spinal fusion surgery (single, and double level).

Subjects will be excluded if they met any of the following criteria: Previous spine surgery, morbid obesity (BMI > 40), spine metastatic tumor, allergy to an amide LA, or magnesium sulfate, heart block, renal, or liver dysfunction, substance abuse disorder, chronic opioid use, or electrolyte disturbance , administration of any sedative, preexisting mental illness, psychological or emotional problems.

Randomization will be performed using lidocaine group, magnesium group, combined (lidocaine and magnesium) group and control group registers, which will be placed in sealed envelopes prior to study initiation, and opened prior to anesthesia by a physician who will prepare the IV solution, and identify it with the patient number, according to the envelope drawn. The solution will be handed to another physician, blind to the prepared solutions' content, who will be responsible for the anesthesia. The solution volume will be equal. The responsible investigator will remain blind to the chosen group until the end of the study.

Allocation concealment will be done using serially numbered closed, opaque envelopes. Each patient will be given a serial number from a computer-generated randomization table, and will be placed in the appropriate group after opening the corresponding sealed envelope. Counseling for participation will be conducted before recruitment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Care Provider)

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

  • ASA status I, II and III patients
  • Age 18 - 60 y
  • Gender: both male and female
  • Undergoing spinal fusion surgery (single, and double level).

排除标准

  • Previous spine surgery
  • Morbid obesity (BMI > 40)
  • Spine metastatic tumor
  • Allergy to an amide LA, or magnesium sulfate
  • Heart block, renal, or liver dysfunction
  • Substance abuse disorder, or chronic opioid use, administration of any sedative or preexisting mental illness.
  • Electrolyte disturbance.
  • Psychological or emotional problems.

研究组 & 干预措施

control group

Placebo Comparator

30 patients will receive IV saline 50 ml plus IV saline 50 ml over 30 min. after induction of anesthesia.

干预措施: IV saline (Drug)

Lidocaine group

Active Comparator

30 patients will receive IV lidocaine 4 mg/kg in 50 ml volume over 30 min. plus IV saline 50 ml after induction of anesthesia.

干预措施: Lidocaine IV (Drug)

Lidocaine group

Active Comparator

30 patients will receive IV lidocaine 4 mg/kg in 50 ml volume over 30 min. plus IV saline 50 ml after induction of anesthesia.

干预措施: IV saline (Drug)

Magnesium group

Active Comparator

30 patients will receive IV magnesium sulfate 30 mg/kg in 50 ml volume over 30 min. plus IV saline 50 ml after induction of anesthesia.

干预措施: Magnesium Sulfate Injection (Drug)

Magnesium group

Active Comparator

30 patients will receive IV magnesium sulfate 30 mg/kg in 50 ml volume over 30 min. plus IV saline 50 ml after induction of anesthesia.

干预措施: IV saline (Drug)

Combination group

Active Comparator

30 patients will receive IV lidocaine 4 mg/kg in 50 ml volume over 30 min. plus IV magnesium sulfate 30 mg/kg in 50 ml volume over 30 min. after induction of anesthesia.

干预措施: Lidocaine IV (Drug)

Combination group

Active Comparator

30 patients will receive IV lidocaine 4 mg/kg in 50 ml volume over 30 min. plus IV magnesium sulfate 30 mg/kg in 50 ml volume over 30 min. after induction of anesthesia.

干预措施: Magnesium Sulfate Injection (Drug)

结局指标

主要结局

short-term postoperative pain control

时间窗: first 24 hours postoperative (Day 0)

Short-term pain control will be assessed in the first 24 hours postoperative. by numeric rating scale (NRS). It ranges from 0 to 10 where 0= no pain and 10= maximum pain

次要结局

  • long-term pain control(Every month till 3 months (Month 1, Month 2, Month 3))
  • Total opioid consumption(Every month till 3 months (Month 1, Month 2, Month 3))
  • Mental state, Anxiety and depression , quality of life(6 hours postoperative, 24 hours postoperative, 1 week postoperative, 4 weeks postoperative)

研究者

发起方
Haitham Mohammad Ahmad Mohammad
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Haitham Mohammad Ahmad Mohammad

Principal investigator

Assiut University

研究点 (1)

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