Intra-Articular Adrenaline Versus Tourniquet in Knee Arthroscopy: A Cohort Study
Intra-Articular Adrenaline Versus Tourniquet in Knee Arthroscopy in a Tertiary Care Center: A Prospective Cohort Study
Arthroscopy has become one of the most commonly performed orthopaedic surgeries in the world due to it being a minimally invasive technique. Clear visualization is crucial for both safe and efficient arthroscopic procedures. Pneumatic tourniquet has been widely used in knee arthroscopic surgeries to obtain bloodless surgical field, improve visualization, and thereby surgical time. However, complications from tourniquet use are not uncommon, particularly in patients whose procedure takes longer than 60 minutes. Using a tourniquet could increase problems, such as electromyographic alterations, nerve compressions, arterial occlusions, delayed muscle recovery, and muscle weakness.
Intra-articular adrenaline injection creates a bloodless field by reducing local perfusion through its vasoconstrictive properties, mimicking the effect of a tourniquet. It appeared to be a potentially effective and safe option. Therefore, this study aimed to evaluate intra-articular adrenaline infiltration as an alternative for achieving a bloodless field without tourniquet-related side effects, in terms of clinical efficacy, operative duration and safety. We would compare intra operative visibility and safety of intra articular adrenaline (1:200,000) injections with use of a tourniquet in arthroscopic knee surgeries. Comparision is made between one group that received standard tourniquet application and another group that received intra articular adrenaline injection. Then the intraoperative visibility in these two groups is compared using tools like surgeon visual analogue score and amount of irrigation fluid required. The effectiveness and safety of the method used is compared using appropriate statistical tools.
Null Hypothesis: There is no difference in intraoperative visibility and safety during knee arthroscopic surgeries with standard tourniquet application versus intraarticular adrenaline injection.
H0: outcome in Adrenaline group =< outcome in Tourniquet group
Alternative Hypothesis: Intra articular adrenaline injection is better than tourniquet use in arthroscopic knee surgeries with respect to operative field visibility and safety.
H1: outcome in Adrenaline group > or (not less than) outcome in Tourniquet group
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Bagmati
-
Dhulikhel、Bagmati、尼泊尔、45200
- Dhulikhel Hospital, Kathmandu University Hospital
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients who are skeletally matured (18 year and above) undergoing knee arthroscopic surgeries.
The surgeries included are:
- Anterior Cruciate Ligament reconstruction
- Anterior Cruciate Ligament repair
- Anterior Cruciate Ligament decompression
- Meniscus repair surgeries
- Meniscus resection surgeries - Patients who provide consent for the study
Exclusion Criteria:
The patient with following procedures are excluded:
- Posterior Cruciate Ligament (PCL) surgeries
- Multi-ligament surgeries
- Osteochondral or intra articular fractures
- Patients under 18 years of age
- Patients who do not provide consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Adrenaline Administration
|
Both groups will be injected at portal and intra-articular with an injection solution (Group A will be infiltrated with 60 ml of normal saline only and Group B will be injected with 60 ml of 1:200,000 adrenaline diluted in 100 ml of normal saline)
|
|
有源比较器：Tourniquet Administration
|
The tourniquet in all groups are applied over proximal thigh with well-padded cotton and inflated (only in Group A - Tourniquet Administration Group's) to 100 -150mm of Hg higher than systolic pressure of the patient.
Other group - Group B, have no inflation of tourniquet, but only applied.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Intraoperative Visibility Assessed by Surgeon Visual Analogue Scale (VAS)
大体时间：1.5 years
|
Intraoperative visibility during arthroscopic knee surgery will be assessed by the operating surgeon using a 10-point Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates excellent visibility and 10 indicates extremely poor visibility.
Lower scores indicate better operative visibility.
|
1.5 years
|
|
Intraoperative Irrigation Fluid Requirement
大体时间：1.5 years
|
The total volume of irrigation fluid used during arthroscopic knee surgery will be recorded in milliliters (mL).
Lower irrigation fluid requirement indicates better operative visibility and efficiency.
|
1.5 years
|
合作者和调查者
出版物和有用的链接
一般刊物
- Noordin S, McEwen JA, Kragh JF Jr, Eisen A, Masri BA. Surgical tourniquets in orthopaedics. J Bone Joint Surg Am. 2009 Dec;91(12):2958-67. doi: 10.2106/JBJS.I.00634.
- Karaoglu S, Dogru K, Kabak S, Inan M, Halici M. Effects of epinephrine in local anesthetic mixtures on hemodynamics and view quality during knee arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2002 Jul;10(4):226-8. doi: 10.1007/s00167-001-0257-8. Epub 2001 Nov 23.
- Zhongyu X, Zhen Y, Bingqing G, Xintian K, Meifeng G, Jianda X. Intra-articular administration of adrenaline plus an irrigation pump system for visibility during the arthroscopic reconstruction of multiple knee ligaments without a tourniquet. Front Surg. 2023 Mar 17;10:1045839. doi: 10.3389/fsurg.2023.1045839. eCollection 2023.
- Kirkley A, Rampersaud R, Griffin S, Amendola A, Litchfield R, Fowler P. Tourniquet versus no tourniquet use in routine knee arthroscopy: a prospective, double-blind, randomized clinical trial. Arthroscopy. 2000 Mar;16(2):121-6. doi: 10.1016/s0749-8063(00)90024-0.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.