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临床试验/NCT02322346
NCT02322346已完成4 期

Peritonsillar Infiltration With Levobupivacaine for Relief of Posttonsillectomy Pain: Does Concentration Have Any Effect?

Ankara University0 个研究点目标入组 70 人开始时间: 2008年8月最近更新:
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
70
主要终点
Change in postoperative pain

研究概览

简要总结

The investigators aimed to evaluate the effects of different concentrations of preincisional peritonsillar levobupivacaine (0.25% ve 0.5%) on postoperative pain and bleeding

详细描述

72 ASA I-II patients between 3 and 12 years of age who scheduled to undergo tonsillectomy were enrolled in this randomized, prospective and placebo-controlled study. The indications for tonsillectomy were recurrent infections and tonsillar hypertrophy leading to obstructive symptoms.

The patients included to the study were randomly assigned to one of the 3 groups to receive different concentrations of levobupivacaine or saline.

The mean arterial pressure (MAP) and heart rates (HR) of all patients were recorded during the whole anesthesia and surgical procedures. The duration of anesthesia and surgery were also recorded. Additional remifentanil 1 µgr kg-1 IV was administered to the patients if HR was increased by 25 % of the basal value.

During postoperative period, symptoms such as pain, fever and dysphagia, adverse affects such as nausea and vomiting and hemorrhage were evaluated. Pain was evaluated by FLACC (Faces, leg, activity, cry, consolability), FPRS (Faces pain rating scale) ve Wong-Baker facies scales at postoperative 0, 30 and 60 minutes and 2, 6, 12 and 24 hours. Total analgesic consumption during the postoperative period were recorded. If the patients had no complication, they were discharged at the postoperative 24th hour.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients aged 3 and 12 who were scheduled to undergo tonsillectomy due to recurrent infections leading to obstructive symptoms
  • Patients aged 3 and 12 who were scheduled to undergo tonsillectomy due to tonsillar hypertrophy leading to obstructive symptoms.

排除标准

  • Hypersensitivity to sevoflurane, benzodiazepine, fentanyl analogues, propofol and components, paracetamol, levobupivacaine
  • Presence of coagulation disorders and chronic diseases
  • Presence of regular use of analgesics
  • Presence of analgesic use within 24 hours prior to surgery
  • Presence of upper respiratory system infection
  • Inability to understand the pain scales, being unable to communicate.

研究组 & 干预措施

Group S

Placebo Comparator

Preincisional bilateral peritonsillar infiltration of a total of 6 mL of saline

干预措施: Group S (Other)

Group LL

Active Comparator

Preincisional bilateral peritonsillar infiltration of levobupivacaine 0.25% (3 mL to each tonsil).

干预措施: Group LL (Drug)

Group HL

Active Comparator

Preincisional bilateral peritonsillar infiltration of levobupivacaine 0.5% (3 mL to each tonsil).

干预措施: Group HL (Drug)

结局指标

主要结局

Change in postoperative pain

时间窗: 24 hours

pain assessed with FPRS (Faces pain rating scale)

次要结局

  • Presence of dysphagia(24 hours)

研究者

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

Sanem Cakar Turhan

Specialist

Ankara University

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