Evaluation of Ropivacaine and Ropivacaine Plus Magnesium Sulphate Infiltration for Postoperative Analgesia in Patients Undergoing Thyroidectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Efficacy of Ropivacaine Plus Magnesium Sulphate Infiltration vs Ropivacaine
研究概览
简要总结
In the domain of endocrine gland surgery, thyroidectomy is the most common procedure. Patients report moderate to severe discomfort postoperatively, which is induced by a variety of mechanisms, the most common of which are cervical incision and surgical maneuvers. The other two causes are endotracheal intubation and neck overextension. Incisional pain, odynophagia, dysphagia, neck and shoulder pain have all been reported as sources of discomfort.However, it seems that this discomfort has a time limit, with a considerable decrease in pain scores that will last 24 to 36 hours. Pain is felt more profoundly within the first few hours after surgery, peaking at 6 hours, with patients requesting further analgesic medication.
Surgical wound infiltration can inhibit this procedure by preventing the alginate signal from reaching the incision site's receptors. According to the multimodal analgesia trends, magnesium sulfate can be added to the ropivacaine solution. Magnesium acts as an NMDA (N-methyl-D-aspartate) receptor antagonist, inhibiting cerebral sensitization to peripheral pain stimuli while reducing pre-existing hyperalgesia.
It becomes evident that this combination could contribute to attain the maximum analgesic efficacy. So, if any superiority of ropivacaine plus magnesium sulphate over ropivacaine could be demonstrated this would be very helpful in providing sufficient analgesic effects with a low incidence of adverse effects, while enhancing the option of one day 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
- Double (Participant, Outcomes Assessor)
盲法说明
Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient ≥ 18 years old
- •Surgical indication for Total thyroidectomy
- •Surgical indication forparathyroidectomy
排除标准
- •Patients < 18 years old
- •Prior neck operation
- •Lateral neck dissection
- •Patient with history of chronic opioid use
- •Patient with chronic pain syndromes
- •Patient with allergy to ropivacaine
研究组 & 干预措施
Ropivacaine 10%
Wound infiltration with 12 ml solution of 100mg ropivacaine at the end of surgery before wound closure
干预措施: Ropivacaine 10% (Drug)
Ropivacaine 10% magnesium sulphate 10mg/kg
Wound infiltration with 12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery before wound closure
干预措施: Ropivacaine 10% plus magnesium sulphate 10mg/kg (Drug)
结局指标
主要结局
Efficacy of Ropivacaine Plus Magnesium Sulphate Infiltration vs Ropivacaine
时间窗: 24 postoperative hours
Calculation of the total post-operative analgesic doses administered, converted to effective mg of morphine.
次要结局
- Subjective measurements 2(30 minutes before the infiltration, 6 hours and 24 hours postoperatively)
- Subjective measurements 3(30 minutes before the infiltration, 6 hours and 24 hours postoperatively)
- Incisional Pain(30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours)
- Subjective measurements 1(30 minutes before the infiltration, 6 hours and 24 hours postoperatively)
- Complications(24 hours, 7 days)
研究者
Styliani Konstantinos Laskou
Principal Investigator
Aristotle University Of Thessaloniki