Effect of 2% Lignocaine Solution in Pain During Removal of Nasal Pack
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- This study is used to determine whether re-hydrating Merocel nasal packs with 2% Lignocaine reduces pain during nasal pack removal.
研究概览
简要总结
To evaluate the efficacy of rehydration of Merocel nasal packs with 2% Lignocaine on reducing pain and discomfort during nasal pack removal in patients undergoing septoplasty.
详细描述
This study will be carried out in patients who have undergone septoplasty for deviated nasal septum under general anesthesia, and who are categorized as American Society of Anesthesiologists (ASA) grade I to II. Consent will be obtained from the patient for the same.
Septoplasty will be carried out under general anesthesia and in all patients Merocel nasal packs (expandable polyvinyl acetate nasal packing) that expand upon contact with fluid will be used.
The postoperative analgesia will include Ibuprofen 400mg + Paracetamol 500mg combination thrice daily and Ketorolac 30mg intravenous when needed. The packs will be removed on the second postoperative day, 48 hours after packing.
During nasal pack removal, the subjects will be randomly divided into 2 groups: the Lignocaine group (2% lignocaine HCl) and the Normal saline group (0.9% NaCl) using simple random sampling by lottery method. Subjects won't know which group they belong to and what medication they will be receiving. A 23-gauge needle will be used for direct application of the treatment to the Merocel, with care taken not to touch the patient.
In the Lignocaine group, 2.5 ml of 2% of lignocaine is diluted with 2.5 ml of distilled water, and the 5ml solution will be injected into the Merocel pack 15 minutes before removal of the pack. Nothing will be done to the opposite nostril, which would act as a control.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic deviated nasal septum undergone Septoplasty surgery with bilateral anterior nasal packing
排除标准
- •History of previous nasal surgeries
- •Nasal polyposis
- •Allergic rhinitis
- •Chronic sinusitis
- •Patient with neurological and psychiatric disease
- •Patient with sensitivity to anesthetic agent in study
- •Patients unwilling to enroll in the study
研究组 & 干预措施
2% lignocaine
In the Lignocaine group, 2.5 ml of 2% of lignocaine is diluted with 2.5 ml of distilled water, and the 5ml solution will be injected into the Merocel pack 15 minutes before removal of the pack. Nothing will be done to the opposite nostril, which would act as a control.
干预措施: Lignocaine 2% Injection 20Ml Vial (Product) (Drug)
Normal saline
In the Normal saline group, 5 ml of normal saline was injected into the Merocel pack 15 minutes before removal of the pack. Nothing will be done to the opposite nostril.
干预措施: Normal saline (Drug)
结局指标
主要结局
This study is used to determine whether re-hydrating Merocel nasal packs with 2% Lignocaine reduces pain during nasal pack removal.
时间窗: During Nasal pack removal at 48 hrs post operative
Post-operative pain severity was assessed with Visual Analogue Scale (VAS). It's a 10cm scale in which 0 represents no pain at all and 10 represents the worst pain imaginable. This would find out if rehydrating nasal pack with mentioned material decreases pain caused to the patient during pack removal.
次要结局
未报告次要终点
研究者
Dr Ashish Dhakal
Lecturer
Dhulikhel Hospital