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临床试验/NCT05557734
NCT05557734招募中不适用

Comparative Study Between Caudal and Perianal Block on Intraoperative Anal Sphincter Muscle Tone and Postoperative Analgesia During Anal Sphincter Sparing Procedures Under General Anesthesia

Cairo University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2023年10月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
46
试验地点
1
主要终点
time to first analgesic request after the recovery of the patient.

研究概览

简要总结

Anal fistula is an abnormal tract communicating an external opening in the perianal skin with an internal opening in the anal canal. Anal fistula is treated by fistulotomy . sphincter sparing procedures are usually done under general anesthesia omitting neuromuscular blocking agents in order to preserve sphincter tone intraoperatively. The aim of this study is to evaluate the effect of caudal block analgesia versus perianal block analgesia combined with general anesthesia on the postoperative analgesic profile and the tone of external anal sphincter in sphincter sparing surgery.

详细描述

Anal fistula is an abnormal tract communicating an external opening in the perianal skin with an internal opening in the anal canal. Anal fistula is treated by fistulotomy . sphincter sparing procedures are usually done under general anesthesia omitting neuromuscular blocking agents in order to preserve sphincter tone intraoperatively.

The study will be designed to recruit 46 patients who have complex anal fistula and will be scheduled for sphincter sparing surgery.

All patients will receive routine preanesthetic evaluation. They will be kept fasting for2 hours for clear fluids and at least 8 hours for solid food prior to performing the block. On arrival in the operating room, heart rate (HR), non invasive blood pressure, oxygen saturation (SPO2) and electrocardiography monitors will be applied and the baseline values will be noted. Intravenous access (IV) will be secured and an appropriate IV fluid will be started.

Patients will receive general anesthesia with induction of 2mg/kg IV propofol, 1mcg/kg IV fentanyl and laryngeal mask insertion in supine positionand maintenance of anesthesia with isoflurane inhalation.

Patients will be randomly allocated into two study groups;

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

Double blinded(the surgeon and the outcome assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18-60 years old patients
  • •ASA I-IIIpatients
  • •Patients with complex anal fistula

排除标准

  • •known hypersensitivity to amide type local anesthetics
  • •Patients with contraindications to caudal block or perianal block: use of anticoagulant medication, local infection in the intervention site, increased intracranial pressure and severe aortic and / or mitral valve stenosis.
  • •Patients who do not accept regional anesthesia
  • •BMI (Body mass index) > 35 kg/m2
  • •Anatomical abnormalities and previous surgeries involving the sacrum

研究组 & 干预措施

caudal epidural group

Active Comparator

the patient will be positioned in lateral position, sterilized from the iliac crest margin to the lower buttock by betadine and will be covered by sterile drapes exposing the sacral area. Sacral horns will be palpated and sacral hiatus and epidural area will be determined at S4-S5 level through the ultrasound. Short axis (transverse) will be used first to identify the two sacral cornua as two hyperechoic reverse U-shaped structure "Frog sign" and the sacrococcygeal ligament in between and epidural space beneath. An 18-gauge epidural needle (length 90 mm) will be used for direct puncture of sacrococcygeal membrane out of plane then the probe will be rotated to long axis (longitudinal) and the needle will be seen in plane in the epidural space. Injection of 40 ml 0.125% bupivacaine will expand the epidural space. The patient will be repositioned to lithotomy position and surgery will start after 5 min. of preparing the patient and sterilization to the surgery

干预措施: caudal block (Procedure)

perianal block group

Active Comparator

, the patient will be in the lithotomy position, paint and drape the area of the block under strict aseptic precaution, draw a circle with a radius of 2.5cm around anal opening, mark a point at 2,4,8,10 clock position, prepare 40 ml 0.125% bupivacaine, use 1.5-inch 23/24 gauge needle connected to 10 ml syringe, insert full length of the needle into the ischiorectal fat immediately peripheral to the external sphinchter. This injection scheme target the terminal nerve branches of the anus rather than blocking the trunk of major nerves. At 2 clock position, inject 2-3 ml of LA with tilting in lateral direction,withdraw needle 1cm and after every 1cm inject 2-3ml of LA, repeat procedure at 4,8,10 clock position, remaining around 10 ml of LA is used to infiltrate in subcutaneous tissue in circumference of anal opening.

干预措施: perianal block (Procedure)

结局指标

主要结局

time to first analgesic request after the recovery of the patient.

时间窗: 24 hours

duration of postoperative analgesia

次要结局

  • postoperative pain intensity(24 hours)
  • incidence of complications(24 hours)
  • Assessment of External anal sphincter muscle tone intraoperative(2 hours)
  • Total post operative opioid consumption(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abd elmoneim Adel Abd elmoneim

clinical professor

Cairo University

研究点 (1)

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