Compartive Study Between Caudal and Perianal Block During Anal Sphincter Sparing Procedures Under General Anesthesia
NCT ID: NCT05557734
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
46 participants
INTERVENTIONAL
2023-10-14
2024-02-29
Brief Summary
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Detailed Description
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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;
* 1st group (caudal block group): will receive general anesthesia with ultra sound (u/s) guided caudal block with 40 ml 0.125% bupivacaine (10 ml bupivacaine + 30 ml normal saline 0.9%).
* 2nd group (perianal block group): will receive general anesthesia with perianal block analgesia with 40 ml 0.125% bupivacaine (10 ml bupivacaine + 30 ml normal saline 0.9%).
Intraoperative, optimal surgical conditions and persistence of muscle tone will be determined by the general surgeon according to patient's anal sphincter relaxation using Digital Rectal Examination Scoring System (DRESS) which ranges from 0 to 5 but with usage of resting pressure only without squeezing pressure as the patient is anesthetized.
Postoperativepain control regimen will be used for the two groups as Paracetamol 15mg/kg IV /6 hours, Ketorlac 30 mg IV /8hours. A rescue analgesic dose of opioid in the form ofMorphine 0.05mg/kg as needed on patient demand if numeric pain score is more than three to be repeated every 20 min. till maximum dose 0.2mg/kg. if numerical rating score persists more than three.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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caudal epidural group
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
caudal block
injection of local anesthestic through the scral hiatus into the sacral canal to reach caudal epidural space
perianal block group
, 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.
perianal block
local anesthestic infiltration in the perianal area to block terminal branches of the nerves supplying the anal canal
Interventions
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caudal block
injection of local anesthestic through the scral hiatus into the sacral canal to reach caudal epidural space
perianal block
local anesthestic infiltration in the perianal area to block terminal branches of the nerves supplying the anal canal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA I-IIIpatients
* Patients with complex anal fistula
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Abd elmoneim Adel Abd elmoneim
clinical professor
Principal Investigators
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Osama M Assad, professor
Role: PRINCIPAL_INVESTIGATOR
Anesthesia department , cairo university
Amany H Saleh, assprofessor
Role: STUDY_DIRECTOR
Anesthesia department , Cairo university
Mona H Elsherbiny, lecturer
Role: STUDY_CHAIR
Anesthesia department , cairo university
Locations
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Cairo university hospitals
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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abdelmoneim A abdelmoneim, lecturer
Role: primary
Other Identifiers
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MD-276-2021
Identifier Type: -
Identifier Source: org_study_id