Influence of Regional Anaesthesia on the Expression of Substance P During Unilateral Neck Dissection Due to Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Expression of Substance P
研究概览
简要总结
In the clinical trial the investigators will observe the impact of regional anesthesia in addition to a general anesthesia on the expression of substance P in patients with unilateral Head or Neck cancer undergoing unilateral Neck Dissection. The investigators will perform an unilateral regional cervical plexus block on the tumor side. The tissue of the tumor side will be analysed by immunohistology, measuring the expression of the Substance P.
详细描述
Several investigations show that anesthetic procedures, and especially the perioperative regional anesthesia, can have a benefit for patients undergoing tumor surgery.The perioperative regional anesthesia might reduce the immunological response and therefore lower the risk of tumor relapse. Factors that might play a role in tumor relapse are various, so more prospective and randomised trials are necessary to investigate the underlying mechanisms.
In a retrospective analysis by Merquiol et al. it was shown that an cervical epidural anesthesia was associated with an extended tumorfree timeline of larynx and hypopharynx carcinoma.
Supporting results could be seen in a study by Munoz et al. performing regional anaesthesia in breast cancer patients.
Taking all these facts into consideration the investigators believe that performing regional aneasthesia could reduce the relapse of larynx carcinoma. The relapse of carcinoma is believed to be linked to substance P and the neurokinin 1 (NK-1) receptor .
It is accepted that an additional regional anesthesia could reduce the impact of substance P to gain a normal immune response in the perioperative setting and to reduce the rate of tumor relapse.
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
- None
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 at Charité - Universitaetsmedizin Berlin, Campus Charité Mitte
- •Primary diagnosis of unilateral head or neck cancer
- •Resection of Tumor is planned with unilateral neck dissection
- •Patient did not underwent any therapeutic treatment of the cancer before start of study
- •Surgical therapy is planned with curative intent
排除标准
- •Allergy to local anesthetics
- •Coagulation disorders, which can lead to complications in regional anesthesia
- •Insulin-dependent diabetes mellitus, polyneuropathy
- •Severe psychiatric disorders
- •Alcohol abuse, Korsakoff syndrome
- •Medication with immunosuppressants or immune modulantia
- •Patient under Special Care
- •Refusal of study participation
- •Pregnancy and breast feeding period.
- •Participation in a clinical intervention study, parallel with the study or participation up to 30 days before inclusion
- •Lack of consent that pseudonomized data of the study may be saved and distributed
研究组 & 干预措施
SPRANC Block group
General anaesthesia and additional regional anaesthesia (cervical plexus block) on the tumor side.
干预措施: SPRANC Block group (Drug)
SPRANC Control group
General anaesthesia
干预措施: SPRANC Control group (Drug)
结局指标
主要结局
Expression of Substance P
时间窗: 2 years
次要结局
未报告次要终点
研究者
Jurgen Birnbaum
Principal Investigator of the Department of Anesthesiology and Intensive Care Medicine, Charité - University Medicine Berlin
Charite University, Berlin, Germany