A randomised controlled trial on periprocedural analgesia among fissure in ano patients undergoing LIS under perianal versus saddle block anesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess the peri-procedural pain relief for Lateral Internal Sphincterotomy in fissure in ano patients under peri- anal versus saddle block anesthesia by comparing VAS-P at 6 hours and 24 hours
研究概览
简要总结
The majority of acute anal fissures resolve without surgical intervention. The goals of nonoperative therapy are straightforward and consist of three components. The first component is to remove the underlying pathology responsible for the creation of the fissure. This often means the alleviation of constipation and straining, as well as avoidance of other causes of anal trauma. Frequent sitz baths, stool softeners, adequate fluid intake and a high-fibre diet are recommended. The second component involves the relaxation of the internal anal sphincter to improve blood flow and allow healing. This can be achieved through topical nifedipine, topical nitro-glycerine or botulinum toxin injections. The third component consists of reducing the symptoms from the fissure, which are typically bleeding and pain. Topical analgesics such as 2% lidocaine jelly are usually prescribed.
Local application of muscle relaxing therapy may be used in healing chronic anal fissure when considerable risk for surgery is present. These therapies include nitro-glycerine ointment, botulinum toxin, calcium channel blockers (diltiazem or nifedipine), hydrocortisone or topical anaesthetic ointment principally lignocaine, sitz baths. These therapies esp. GTN offers symptomatic relief and anti-inflammatory effects and possibility of avoiding surgery.
When chronic fissures develop, healing is more difficult to achieve. Conservative methods are likely to fail and have a higher failure rate with chronically recurring anal fissures. In these situations, the gold standard is the lateral internal sphincterotomy (LIS). Lateral internal sphincterotomy is the surgical treatment of choice for refractory anal fissures and may be offered without pharmacologic treatment failure according to the practice parameters by the American Society of Colon and Rectal Surgeons.
Although these commonly performed anorectal operations are short in duration the dense sensory supply of the perineum leads to significant post-operative pain, making adequate anaesthesia crucial.
General or regional (spinal, caudal) anaesthesia is predominantly used for anorectal surgery. Ano-rectal surgeries performed under conventional anaesthesia (GA/SA) are fraught with numerous side effects, such as, drowsiness, headache, nausea, vomiting, sore throat, backache, post operative pain and urinary retention. In addition to the need for anaesthetists’ expertise, GA/SA impose restrictions on pre/post procedural oral intake & movement, necessitate close inpatient post operative monitoring and contribute towards additional operation room time consumption, making them rather patient and surgeon unfriendly.
In the recent years several studies explored the use of local anaesthesia for anorectal surgery as an outpatient procedure with encouraging results. But significant proportion of surgeons still tend to perform LIS in the hospital, using spinal anaesthesia despite associated side effects and burden of hospitalization.
The aim of this study is to further explore the viability of peri-anal block in Lateral Internal Sphincterotomy.
PRIMARY RESEARCH QUESTION:
Is Perianal Block equally efficacious as Saddle block anesthesia for peri-procedural pain relief in Lateral Internal Sphincterotomy for Anal Fissures?
NULL HYPOTHESIS:
Visual Analogue Scale – Pain (VAS-P) scores at 6 hours, 24 hours are higher among fissure in ano patients undergoing LIS under peri-anal block than fissure in ano patients undergoing LIS under saddle block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Anal Fissure Patients undergoing LIS during the study period ii.
- •18 years of age or older iii.
- •Able to give informed, written consent iv.
- •Classified by the American Society of Anaesthesiologists (ASA) as I and II.
排除标准
- •Patients with other concurrent peri-anal pathologies ii.
- •Patient With history of previous peri-anal surgeries.
结局指标
主要结局
To assess the peri-procedural pain relief for Lateral Internal Sphincterotomy in fissure in ano patients under peri- anal versus saddle block anesthesia by comparing VAS-P at 6 hours and 24 hours
时间窗: 6 hours and 24 hours
次要结局
- (I) To compare the mean time to requirement of rescue analgesia after Lateral Internal Sphincterotomy in fissure in ano patients under peri- anal versus Saddle block anesthesia
研究者
Dr Narendra Chhettri
Armed Forces Medical College, Pune
