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临床试验/NCT02870556
NCT02870556Unknown不适用

Effect of Cervical Epidural Analgesia on the Occurrence of Pharyngocutaneous Fistula Following Salvage Laryngectomy and Reconstruction With Pectoralis Major Myocutaneous Flap

Assiut University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2016年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
46
试验地点
2
主要终点
pharyngocutaneous fistula following salvage laryngectomy and reconstruction with pectoralis major myocutaneous flap

研究概览

简要总结

Pharyngocutaneous fistula (PCF) is the most commonly reported postoperative complication in total laryngectomy patients. PCF significantly increases morbidity, length of hospitalization, and cost of care, in addition to delaying the beginning of adjuvant therapy. The reported incidence of PCF ranges from 3% to 65%.The increased use of radiation in the primary management of laryngeal carcinoma has resulted in an increase in the PCF formation after salvage laryngectomy (STL).

Previously reported risk factors for PCF development include preoperative radiotherapy, tumor stage, concomitant neck dissection, prior need for tracheotomy, hypoalbuminemia and anemia.

Among surgical options, the pectoralis major myofascial flap has been proposed to cover the pharyngeal closure, to interpose non-irradiated tissue between the neopharynx and the skin during STL. Nonetheless, the efficacy of this approach is not fully established.Epidural anesthesia improves the blood supply due to its vasodilating effect. The aim of the study is to evaluate the effect of perioperative cervical epidural analgesia on the occurrence of pharyngocutaneous fistula following salvage laryngectomy and reconstruction with pectoralis major myocutaneous flap.

详细描述

Patients will be divided into two equal groups, group (EP), will receive perioperative cervical epidural analgesia in addition to general anesthesia and group (GA) will receive general anesthesia and postoperative analgesia through patient controlled intravenous morphine analgesia (PCA), that involve 1 mg continuous infusion and 2 mg boluses with lockout interval 10 min.

Cervical epidural technique: epidural needle will be inserted at C 6-C7 or C7-T1 under fluoroscopy in prone position, 6 ml of 0.125% bupivacaine and fentanyl 2 mic/ ml will be administered before skin incision followed by 4 ml of the same injectate, will be infused continously for 2 days

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who failed treatment with radiotherapy for laryngeal cancer

排除标准

  • Infection at the site of flap
  • Primary laryngectomy without radiotheraapy

研究组 & 干预措施

EP, Cervical epidural group

Experimental

patients undergoing salvage laryngectomy (failed radiotherapy to treat laryngeal cancer) will receive cervical epidural analgesia in addition to the standard general anesthesia (induction with propofol 2 mg / kg, endotracheal intubation facilitated by cis-atracurium 0.3 mg / kg and 0.15 mg /kg on demand and maintained with inhalational anesthetic sevoflurane) Cervical epidural technique: epidural needle will be inserted at C 6-C7 or C7-T1 under fluoroscopy in prone position, 6 ml of 0.125% bupivacaine and fentanyl 2 mic/ ml will be administered before skin incision followed by 4 ml of the same injectate, will be infused continously for 2 days

干预措施: cervical epidural analgesia (Device)

GA, General anesthesia

Active Comparator

patients undergoing salvage laryngectomy (failed radiotherapy to treat laryngeal cancer) will receive standard general anesthesia only (induction with propofol 2 mg / kg, endotracheal intubation facilitated by cis-atracurium 0.3 mg / kg and 0.15 mg /kg on demand and maintained with inhalational anesthetic sevoflurane) in addition to postoperative analgesia through patient controlled intravenous morphine analgesia (PCA), that involve 1 mg continuous infusion and 2 mg boluses with lockout interval 10 min

干预措施: cervical epidural analgesia (Device)

结局指标

主要结局

pharyngocutaneous fistula following salvage laryngectomy and reconstruction with pectoralis major myocutaneous flap

时间窗: 2 weeks postoperatively

次要结局

  • Pain intensity measured by visual analogue scale (VAS)(0 h (immediately postoperative), 2h, 6h, 12h, 24h, 48h (postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diab Fuad Hetta

Dr

Assiut University

研究点 (2)

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