Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Postoperative Pain
研究概览
简要总结
The purpose of this study is to compare the efficacy of Bupivicaine and Lidocaine for postoperative pain control in thyroid surgery.
详细描述
Patients planned for total thyroidectomy will be recruited for participation. After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility for study entry. Patients that meet inclusion and exclusion criteria will be randomized via block randomization in a double blind fashion and a 1:1 ratio to surgical incision infiltration with Bupivacaine (0.5% with 1:200 000 epinephrine) or Lidocaine (2% with 1:100 000 epinephrine).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of thyroid disease (malignant tumors T1-T3/NX-N1a, benign tumors)
- •Planned for thyroid surgery with midline neck incision (total thyroidectomy, completion thyroidectomy, with or without central neck dissection)
- •Will be admitted for at least 12h postoperatively
排除标准
- •Thyroid cancer staged as T4 (invasion, anaplastic) or requiring sternotomy
- •Thyroid cancer staged as N1b (cervical, retropharyngeal, superior mediastinal nodal involvement)
- •Previous ipsilateral thyroid surgery to operation side
- •Previous total thyroidectomy or completion thyroidectomy
- •History of neck radiation therapy
- •Neck dissection beyond central neck (levels 1-5)
- •Goiter extending beyond sternal notch (intrathoracic) or requiring sternotomy
- •Surgery requiring extension of incision beyond 8 cm
- •History of diabetes mellitus
- •History of renal or liver disease
- •History of narcotic abuse
- •History of chronic pain medications use in past 6 months for any condition
- •History of coagulation defect
- •Allergy to Bupivacaine or Lidocaine
结局指标
主要结局
Postoperative Pain
时间窗: 12 hours after surgery
Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
次要结局
- First dose of additional postoperative analgesia(Up to 72 hours after surgery)
- Inpatient analgesia utilization(Up to 72 hours after surgery)
- Outpatient analgesia utilization(Up to 4 weeks after surgery)
- Time to return of sensation(Up to 4 weeks after surgery)
- Incidence of postoperative complications(4 weeks)
- Incidence of local anesthesia related adverse events(4 weeks)
- Postoperative pain(4 week)
研究者
Michael Xie
Resident Physician
St. Joseph's Healthcare Hamilton