Local Wound Infiltration Versus Bilateral Superficial Cervical Plexus Block With Levobupivacaine for Upper Tracheal Resection and Reconstruction Surgery Under General Anesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Postoperative pain score
研究概览
简要总结
Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with tracheal stenosis or tracheal tumors .The postintubation tracheal stenosis is the common indication for (TRR).The immediate postoperative period can be anxiety provoking for some reasons such as requirement to maintain a flexed neck, oxygen mask, and surgical pain which inadequately treated.
Bilateral superficial cervical plexus block (BSCPB) is a popular regional anesthesia technique for its feasibility and efficacy. The use of regional anesthesia in combination with general anesthesia may lighten the level of general anesthesia required , provide prolonged postoperative analgesia and reduce the requirements for opioid analgesics
Local anesthetic infiltration into the surgical incision can relieve pain at the wound site after surgery, as part of multimodal analgesic approach.
Levobupivacaine, is "S"-enantiomer of bupivacaine, has strongly emerged as a safer alternative for regional anesthesia than bupivacaine . Levobupivacaine has been found to be equally efficacious as bupivacaine, but with a superior pharmacokinetic profile. Clinically, levobupivacaine has been observed to be well tolerated in regional anesthesia techniques both after bolus administration and continuous post-operative infusion.
详细描述
The aim of this study is to evaluate the intra- and postoperative efficacy of local wound infiltration versus bilateral superficial cervical plexus block with levobupivacaine for upper tracheal resection and reconstruction 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical class status I or II
- •Undergoing elective upper tracheal resection and reconstruction surgery
排除标准
- •Age less than18 years
- •Patients with preoperative medication included opioid
- •History of allergy to the drugs used
- •Coagulation disorders
- •Pregnancy
- •Patient refusal
- •Local sepsis
- •Inability to understand the study protocol or pain scale.
结局指标
主要结局
Postoperative pain score
时间窗: For 24 hours after surgery
Postoperative pain scores will be assessed using postoperative visual analogue score
次要结局
- Systolic blood pressure(For 4 hours after start of surgery)
- Heart rate(For 4 hours after start of surgery)
- Bispectral index(For 4 hours after start of surgery)
- Peripheral oxygen saturation(For 4 hours after start of surgery)
- End-tidal Carbon dioxide tension(For 4 hours after start of surgery)
- Duration of analgesia(For 24 hours after surgery)
- Cumulative analgesic consumption(For 24 hours after surgery)
- Diastolic blood pressure(For 4 hours after start of surgery)
- Cortisol serum(before induction ,one hour after start of surgery and one hour after end of surgery)