Efficacy of Combination Intravenous Lignocaine and Dexamethasone on Propofol Injection-site Pain: A Randomized double blinded Clinical Trial in Adult Surgical Patients.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- To evaluate the analgesic effect of dexamethasone,lignocaine alone or in combination in reducing the incidence of propofol injection pain.
研究概览
简要总结
Propofol is used intravenously for theinduction and maintenance of anaesthesia.
However, pain in the injectionsite of the arm is one of the main disadvantages of propofol.
The incidence of propofolinjection site painhas been reported to vary from 80% to90% when veins on
the dorsum of the hand is usedfor injection.
•In different studies the authorsconcluded that lignocaine pre-treatment with a rubber tourniquet on the
forearm was effective to decreasepain on injection**.**
However, the failure rate wasabout 15-40%. despite this lignocaine or dexamethasone did not
completely controlpropofol-induced pain despite various methods to reduce propofol injectionpain, the
most effective methods not identified;thus, combination therapy suggested
Propofol releases kininogen fromthe vein wall, which triggers a local kinin cascade, The action of the
products of the kinin cascade onthe nociceptor may be enhanced by prostaglandins.
Dexamethasone inhibits prostaglandinsynthesis and also inhibits bradykinin synthesis, a product of the
plasma kallikrein-kinin cascadeas a potent anti-inflammatory agent
In addition, dexamethasone added tolignocaine for regional IV anaesthesia has been reported to improve
analgesia
Thus, as further research isrequired the present study was conducted to evaluate the efficacy of
Dexamethasone,Lignocaine or combinationisassociated with additional analgesic efficacy compared
with either treatment alone inIndian population
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group between 18 & 75 years ASA grade 1,2 & 3 Elective & Emergency surgeries under G.A.
排除标准
- •Patients not willing to be in the study group, Pregnant patients Known allergy to study drugs Patients with neurological disorders Received analgesic medication < 24 hours before surgery Infection at the site of injection thrombophlebitis psychiatric disorders renal, hepatic, or cardiac problems.
结局指标
主要结局
To evaluate the analgesic effect of dexamethasone,lignocaine alone or in combination in reducing the incidence of propofol injection pain.
时间窗: it is evaluated after 1 minute of injecting the study drug , and during the beginning of injection of propofol
次要结局
- To evaluate the severity of propofol injection site pain with Dexamethasone, Lignocaine alone or in combination(severity of propofol injection pain will be assessed at the end of the study approximate duration for total study 3 to 4 months)