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Compartive Study Between Caudal and Perianal Block During Anal Sphincter Sparing Procedures Under General Anesthesia

Primary Purpose

Acute Post Operative Pain, Motor Activity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
caudal block
perianal block
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Post Operative Pain focused on measuring caudal, perianal block, anal sphincter sparing procedures, postoperative pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    caudal epidural group

    perianal block group

    Arm Description

    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

    , 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.

    Outcomes

    Primary Outcome Measures

    time to first analgesic request after the recovery of the patient.
    duration of postoperative analgesia

    Secondary Outcome Measures

    postoperative pain intensity
    pain measurement will be done using 11 point Numerical rating scale (0-10).
    Assessment of External anal sphincter muscle tone intraoperative
    Digital Rectal Examination Score System(DRESS) 0 no descernable tone at rest very low tone mildly decreased tone Normal Elevated Tone Very high tone, atight anal canal
    Total post operative opioid consumption
    total amount of morphine consumed by the patient in the postoperative period
    incidence of complications
    bradycardia,Hypotension, postoperative nausea and vomiting,urine retention

    Full Information

    First Posted
    September 24, 2022
    Last Updated
    September 24, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05557734
    Brief Title
    Compartive Study Between Caudal and Perianal Block During Anal Sphincter Sparing Procedures Under General Anesthesia
    Official Title
    Comparative Study Between Caudal and Perianal Block on Intraoperative Anal Sphincter Muscle Tone and Postoperative Analgesia During Anal Sphincter Sparing Procedures Under General Anesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    January 2023 (Anticipated)
    Study Completion Date
    February 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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; 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Post Operative Pain, Motor Activity
    Keywords
    caudal, perianal block, anal sphincter sparing procedures, postoperative pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderOutcomes Assessor
    Masking Description
    Double blinded(the surgeon and the outcome assessor)
    Allocation
    Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    caudal epidural group
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    perianal block group
    Arm Type
    Active Comparator
    Arm Description
    , 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    caudal block
    Other Intervention Name(s)
    caudal epidural block
    Intervention Description
    injection of local anesthestic through the scral hiatus into the sacral canal to reach caudal epidural space
    Intervention Type
    Procedure
    Intervention Name(s)
    perianal block
    Intervention Description
    local anesthestic infiltration in the perianal area to block terminal branches of the nerves supplying the anal canal
    Primary Outcome Measure Information:
    Title
    time to first analgesic request after the recovery of the patient.
    Description
    duration of postoperative analgesia
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    postoperative pain intensity
    Description
    pain measurement will be done using 11 point Numerical rating scale (0-10).
    Time Frame
    24 hours
    Title
    Assessment of External anal sphincter muscle tone intraoperative
    Description
    Digital Rectal Examination Score System(DRESS) 0 no descernable tone at rest very low tone mildly decreased tone Normal Elevated Tone Very high tone, atight anal canal
    Time Frame
    2 hours
    Title
    Total post operative opioid consumption
    Description
    total amount of morphine consumed by the patient in the postoperative period
    Time Frame
    24 hours
    Title
    incidence of complications
    Description
    bradycardia,Hypotension, postoperative nausea and vomiting,urine retention
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-60 years old patients ASA I-IIIpatients Patients with complex anal fistula Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abdelmoneim A Abdelmoneim, lecturer
    Phone
    01004392046
    Ext
    202
    Email
    abdelmoneim_adel@kasralainy.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marina B Helmy, resident
    Phone
    01270100924
    Ext
    202
    Email
    marinabassem49@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Osama M Assad, professor
    Organizational Affiliation
    Anesthesia department , cairo university
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Amany H Saleh, assprofessor
    Organizational Affiliation
    Anesthesia department , Cairo university
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Mona H Elsherbiny, lecturer
    Organizational Affiliation
    Anesthesia department , cairo university
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Compartive Study Between Caudal and Perianal Block During Anal Sphincter Sparing Procedures Under General Anesthesia

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