Bupivacaine Application Reduces Postthyroidectomy Pain: Cerrahpaşa Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Post-operative pain in 8 hours after surgery using VAS
研究概览
简要总结
Investigators aimed to evaluate the impact of bupivacaine administration into the surgical field after total thyroidectomy on post-operative pain and analgesic requirement with a double-blind, prospective, clinical, randomized study.
Pain assessment was performed with the visual analog score (VAS). Participants were pre-operatively, divided into two groups randomly to receive either bupivacaine or not. One group received a 10 ml of bupivacaine solution while the other group was treated with the same volume of 0.9% sodium chloride (NaCl) through the drain after completion of total thyroidectomy procedure. All participants were anesthetized and operated with the same anesthesia and surgical team.
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
- Double (Participant, Investigator)
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
- •Subjects need to be operated for thyroid diseases
排除标准
- •History of previous thyroid disease,
- •History of previous neck operations,
- •Hypersensitivity to the drugs that were used in the study protocol,
- •Spinal bone disease,
- •Depression,
- •Kidney failure,
- •Heart failure,
- •Liver failure,
- •Pulmonary failure,
- •Mental retardation,
- •Subjects not able to ascertain pain scoring with the visual analog score (VAS),
- •Patients with American Society of Anesthesiologists (ASA) scores III or higher,
- •Expected airway difficulty according to Mallampati scores,
- •Sedative, steroid, and chronic analgesic drug users,
- •Alcoholics
研究组 & 干预措施
Bupivacaine
bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
干预措施: Thyroidectomy (Procedure)
Bupivacaine
bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
干预措施: Bupivacaine (Drug)
Saline
Saline solution (%0.9 sodium chloride), 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
干预措施: Thyroidectomy (Procedure)
Saline
Saline solution (%0.9 sodium chloride), 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
干预措施: Saline Solution (Drug)
结局指标
主要结局
Post-operative pain in 8 hours after surgery using VAS
时间窗: 8th hour
Evaluation of the pain through the post-operative first 8 hours using VAS
次要结局
- Post-operative pain in in first post-operative day using VAS(1 day)