Effect of Ultrasound-guided Intermediate Cervical Block on Recurrent Laryngeal Nerve Monitoring During Thyroid Surgery : a Randomised Non-inferiority Study
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Effect on recurrent laryngeal nerve monitoring
研究概览
简要总结
Non-inferiority study aimed to assess the impact of cervical block on recurrent laryngeal nerve monitoring during thyroid surgery Secondary outcomes will assess post-operative recovery, post-operative pain and post-operative dysphonia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participant, surgeons and outcomes assessor are blind Only the anesthesiologist taking care of the patient knows the allocation group
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18, able to give consent after clear and fair information
- •Affiliated to social security
- •Total thyroidectomy performed in the context of Graves' disease in biological euthyroidism with the need for surgical treatment (pregnancy project, fluctuating TSH, etc.), or multiheteronodular goiter with suspect or compressive nodules, or lobo-isthmectomy
- •No previous homolateral cervical surgery
- •Professional activity
- •Telephone line (at home or cellular)
排除标准
- •Patients over 18 under legal protection
- •Allergy to local anesthetics
- •Existence of preoperative laryngeal dysphonia or paralysis
- •Patient with a submerging goiter (lower edge of the thyroid not seen on the preoperative cervical ultrasound)
- •Presence of uncontrolled infectious pathology
- •Pregnant or breastfeeding woman or no contraception
- •Lymph node dissection planned or patient at high risk of lymph node dissection (BETHESDA 5 and 6)
研究组 & 干预措施
General anesthesia with intermediate cervical block
General anesthesia performed by the anesthesiologist associated with an echoguided intermediate cervical block (bilateral in total thyroidectomy, unilateral in partial thyroidectomy) : 10 to 30cc of ropivacaine (2 to 3,75 %)
干预措施: Intermediate cervical block (Drug)
结局指标
主要结局
Effect on recurrent laryngeal nerve monitoring
时间窗: Before surgical dissection
Percentage of bilateral and unilateral non-response to recurrent laryngeal nerve monitoring
次要结局
- Postoperative recovery(7 days post surgery)
- Postoperative pain(First 24 hours post surgery)
- Postoperative dysphonia(During the first 24 hours and 7 days post surgery)
- Early postoperative complications(First 24 hours post surgery)
- Late postoperative complications(1 to 3 months post surgery)