Effect of Topically Administered Levobupivacaine- Fentanyl Versus Levobupivacaine- Dexamethasone Combination in the Control of Pain After Endoscopic Sinus Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- time to first post-operative analgesic request
研究概览
简要总结
Chronic sinusitis (CRS) is a high incidence disease characterized by pus, nasal obstruction, olfactory disturbance, headache, and other symptoms, lasting for more than 12 weeks, with severe cases having ocular compression and visual impairment, which can cause cranial, eye, and lung complications. Chronic sinusitis is a high-risk disease.
详细描述
One of the main concerns about using packing is that the removal is usually very painful and can be very bothersome. This procedure may even result in syncope by the activation of the vasovagal reflex system. There have been a few studies suggesting that nasal packs should not be used because removal from the nose causes serious discomfort and is painful. Many patients who have undergone nasal surgery report that the removal of the pack was the most painful part of the experience.
Postoperative pain is an acute inflammatory pain that starts with surgical trauma and ends with tissue healing. It can be harmful to organ systems by initiating inflamma¬tion through different mechanisms, and the alleviation of postoperative pain is considered important for obtaining homeostasis. Pain may initiate atelectasis due to improper coughing, immobilization may cause thromboembolism and catecholamine discharge may induce cardiovascular side effects and undesired changes in neuroendocrine or meta¬bolic function
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •• ASA physical status I-II patients
- •scheduled for elective FESS surgery. • Age from 18 to 65 years patients
排除标准
- •• Age>18 and<65 years patients,
- •Previous history of FESS,
- •Patients with sensitivity to anesthetic agents in the study,
- •Patients who will do additional septoplasty or turbinate surgery,
- •Patients with disturbance of blood coagulation, including pro¬thrombin time (PT)/partial thromboplastin time (PTT) prolon¬gation, purpura, and spontaneous bleeding;
研究组 & 干预措施
Group LD
dexamethasone plus levobupivacaine (5 ml) will be applied.
干预措施: Levobupivacaine Hydrochloride (Drug)
Group C
0.9 NaCl % (Saline) (5 ml)
干预措施: Saline 0.9% (Drug)
Group L
0.25 % levobupivacaine (5 ml) will be applied.
干预措施: Levobupivacaine Hydrochloride (Drug)
Group LF
fentanyl plus 0.25 % levobupivacaine (5 ml) will be applied.
干预措施: Levobupivacaine Hydrochloride (Drug)
Group LF
fentanyl plus 0.25 % levobupivacaine (5 ml) will be applied.
干预措施: Fentanyl (Drug)
Group LD
dexamethasone plus levobupivacaine (5 ml) will be applied.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
time to first post-operative analgesic request
时间窗: 24 hours postoperative
when patient require analgesia
次要结局
未报告次要终点
研究者
Ghada Mohammed AboelFadl
Principal investigator
Assiut University