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临床试验/NCT03269890
NCT03269890已完成不适用

The Efficacy of Intermediate Cervical Plexus Block Versus Cutaneous and Thyroid Capsular Blocks in Thyroid Surgeries

Mansoura University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2017年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
1
主要终点
Total dose of opioid analgesics used

研究概览

简要总结

Thyroid gland surgery is one of the most commonly performed operations for either benign or malignant pathologies Pain related to thyroid surgery is of moderate intensity .which may be treated with NSAIDs or opioids. However, Opioids have many well-known undesirable effects, including postoperative nausea and vomiting, which are frequent after this type of procedure.

详细描述

Regional techniques of anesthesia may help to decrease post-operative pain and reduce systemic analgesic requirement. Classically, the cervical plexus is considered to have two distributions, the superficial cutaneous and the deep motor nerves.

Anatomically, the thyroid gland has an inner true capsule which is thin and adheres closely to the thyroidal tissue [Fancy et al., 2010]. External to this is a false capsule formed by the middle layer of the deep cervical fascia, which splits anterolaterally to ensheathe the thyroid gland, thus forming the thyroid sheath [Bliss et al., 2000]. In this fashion, the potential space called the capsule-sheath space is formed. It contains also loose connective tissue, blood vessels, nerves and parathyroid gland. Anesthetic deposited in this space would block the surface of thyroid gland and permeate directly into the parenchyma producing effective local anesthesia for thyroid surgical procedures. It is supposed also to involve autonomic nerve block of the thyroid gland [Fliers et al., 2010]. Additionally, a subcutaneous injection along the sternocleidomastoid muscle (SCM) would also enhance effective local anesthesia for the initial skin incision and further contribute to a more ideal working environment for the surgeon. Therefore, anesthetic technique termed ultrasound-guided capsule-sheath space block (CSSB) combined with anterior cervical cutaneous nerves block (CCNB) for thyroidectomy is done [Wang et al., 2015] .

Our hypothesis is that a combination of simple dual techniques including superficial cutaneous block to provide sensory blockade, and surgeon mediated capsular block may afford autonomic thyroid blockade. In comparison, ultrasound guided intermediate cervical plexus block may provide these blocks but using a machine and deep penetration possibly involving unwanted blocks for phrenic and recurrent laryngeal nerves. So, if the simple safe technique can provide the same intra and postoperative anesthetic conditions it will be preferred.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status grade I and grade II.
  • Euthyroidism after thyroid function tests

排除标准

  • Patient refusal.
  • Thyroid gland more than 5 cm size.
  • Retrosternal extension.
  • Planned block neck dissection.
  • Neuromuscular diseases
  • Hematological diseases.
  • Bleeding diseases.
  • Coagulation abnormality.
  • Psychiatric diseases.
  • Drug abuse.
  • Local skin infection
  • sepsis at site of the block.
  • Known intolerance to the study drugs.
  • Body Mass Index > 40 Kg/m
  • Known diaphragmatic motion abnormalities
  • major respiratory disease.
  • Previous history of cervical surgery.

研究组 & 干预措施

Capsule and cutaneous blocks

Experimental

7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks per side. once before surgery

干预措施: Capsule and cutaneous blocks (Procedure)

US-intermediate cervical plexus block

Active Comparator

15 mL of 0.5% isobaric bupivacaine + Epinephrine 5 microgram/ ml. per side. once before surgery

干预措施: US-intermediate cervical plexus block (Procedure)

结局指标

主要结局

Total dose of opioid analgesics used

时间窗: For 24 hours after surgery

The total dose of opioid analgesics required in the post-operative periods

次要结局

  • Rocuronium use(For 5 hours after start of anaesthesia)
  • Postoperative headache(For 24 hours after surgery)
  • Postoperative pain(For 24 hours after surgery)
  • Sensory blockade(for 1 hour after surgery)
  • Sedation score(for 5 hours after performing blockade)
  • Time to first analgesic request(For 24 hours after surgery)
  • Patient satisfaction(for 24 hrs after surgery)
  • Respiratory difficulty(For 24 hours after surgery)
  • Fentanyl use(For 5 hours after start of anaesthesia)
  • Postoperative nausea and vomiting(For 24 hours after surgery)
  • Hoarseness of voice(For 24 hours after surgery)
  • Diaphragmatic dysfunction(for 5 hours after performing blockade)
  • Dysphagia(For 24 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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