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临床试验/NCT03036605
NCT03036605已完成4 期

The Postoperative Analgesic Effect of Dexamethasone Added to Topical Bupivacaine in Endoscopic Nasal Surgery

Ataturk University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Analgesic consumption

研究概览

简要总结

Nasal packing is frequently applied after nasal surgery. Nasal packing reduces epistaxis, prevents septal hematoma and stabilizes nasal septum. Nasal mucosa is quite sensitive to pain, therefore the most common problems after surgery are postoperative pain and anxiety during removal of the nasal packing. Lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs, nerve blockade with long-acting local anesthetics, local anesthetics infiltration into nasal packing).

Glucocorticoids have been used as an adjuvant in the management of acute postoperative pain. Perineural dexamethasone as an adjuvant for the single-injection nerve block can prolong analgesia and reduce opioid-requiring after surgery. Furthermore dexamethasone reduces postoperative nausea and vomiting incidance.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologist's physiologic state I-II patients undergoing nasal surgery

排除标准

  • chronic pain
  • bleeding disorders
  • renal or hepatic insufficiency
  • patients on chronic non-steroidal anti-inflammatory medications
  • emergency cases

研究组 & 干预措施

Group Bupivacaine

Active Comparator

4 ml %0.5 bupivacaine and 1 ml %0.9 NaCl infiltration into nasal packing to both sides

干预措施: Bupivacaine (Drug)

Group Bupivacaine+Dexamethasone

Active Comparator

4 ml %0.5 bupivacaine and 4mg(1 ml) dexamethasone infiltration into nasal packing to both sides

干预措施: Bupivacaine (Drug)

Group Bupivacaine+Dexamethasone

Active Comparator

4 ml %0.5 bupivacaine and 4mg(1 ml) dexamethasone infiltration into nasal packing to both sides

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Analgesic consumption

时间窗: Postoperative 24 hours

Analgesic consumption first 24 hours

次要结局

  • Visual analog pain score(postoperative 24th hour)

研究者

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

Ahmet Murat Yayik

MD

Ataturk University

研究点 (1)

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