A comparative evaluation of effect of addition of 8 mg Dexamethasone to 2% Lignocainewith adrenaline in impacted mandibular third molar surgery: A Split Mouth Randomized double blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- the difference in time of onset and duration of local anesthesia.
研究概览
简要总结
Surgical extraction of impacted third molars is a routine minor oral surgical procedure carried out
usually under local anesthesia and is associated with postoperative sequelae including swelling, pain,
trismus, infection, bleeding, and paraesthesia.
Diligent administration of local anesthetic agent will help in achieving pain-free surgical extraction
while also reducing the risk of paresthesia and trismus post-operatively. An increased depth and
duration of action of local anesthetic agent is desirable to minimize the trauma experienced by the
patient intra-operatively and in achieving the pain-free transition from the waning anesthesia to analgesic
medication in the post-operative period respectively.
The goodness of Bupivacaine being a potent, long-acting local anesthetic with low tissue toxicity is
nullified by the undeniable fact that it is the most cardiotoxic of them all, involving both electrical and
mechanical structures within the heart. Therefore a need exists to find an alternative to Bupivacaine
that has a comparable depth and duration of anesthesia.
Studies done in other disciplines of surgery and in vivo studies have shown that using corticosteroids
as adjuncts to local anesthetics have increased the duration of their action in supraclavicular brachial
plexus block, axillary block; sciatic nerve block in rats, and intercostal nerve block in sheep.
Adding corticosteroids would also have the added advantage of reduced swelling, pain, and trismus
owing to an attenuated inflammatory response.
Sizeable research in similar lines has not been done specifically to Oral and Maxillofacial Surgery.
Lignocaine is the gold standard drug of choice for local anesthesia in oral surgery when coupled
Dexamethasone forms a drug combination that deserves testing.
The current study aims to fill the void of insufficient research and test the effect of Dexamethasone
added to Lignocaine with Adrenaline on depth and duration of anesthesia, reduction in swelling,
trismus, pain, and improved mouth opening in patients undergoing impacted third molar surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects falling under ASA class 1 &
- •Subjects requiring surgical extraction of bilateral mandibular third molars in class II position B.
- •Subjects with no acute inflammation, excessive caries, pain and pathology around the mandibular third molars Subjects who have signed the informed consent.
排除标准
- •Subjects with infection around third molars.
- •Subjects with peptic ulcer.
- •Subjects who are pregnant and lactating.
- •Subject with diabetes mellitus, systemic endocrine disorders, hypertension, kidney diseases, blood clotting disorders, obesity.
- •Subjects having an allergy to any of the drugs or materials to be used.
- •Subjects who have used antibiotics in the past 2 weeks.
- •Subjects who have used NSAIDs in the past 1 week.
- •Subjects who could not cooperate Subjects who refused to take part in the study.
结局指标
主要结局
the difference in time of onset and duration of local anesthesia.
时间窗: 1. baseline | 2.2-8 hours after the procedure
次要结局
- the difference in pain, swelling, and mouth opening.(24 hours, 48 hours and 1 week)