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

NCT05557734 | Unknown

• 1 other identifier: MD-276-2021
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Post Operative Pain; Motor Activity

Keywords

caudal; perianal block; anal sphincter sparing procedures; postoperative pain

Outcome Measures

Primary Outcomes (1)

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

  duration of postoperative analgesia

  24 hours

Secondary Outcomes (4)

• postoperative pain intensity

  24 hours

• Assessment of External anal sphincter muscle tone intraoperative

  2 hours

• Total post operative opioid consumption

  24 hours

• incidence of complications

  24 hours

Study Arms (2)

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

Procedure: caudal block

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.

Procedure: perianal block

Interventions

caudal block PROCEDURE

injection of local anesthestic through the scral hiatus into the sacral canal to reach caudal epidural space

Also known as: caudal epidural block

caudal epidural group

perianal block PROCEDURE

local anesthestic infiltration in the perianal area to block terminal branches of the nerves supplying the anal canal

perianal block group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Motor Activity

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Study Officials

• Osama M Assad, professor

  Anesthesia department , cairo university

  PRINCIPAL INVESTIGATOR

• Amany H Saleh, assprofessor

  Anesthesia department , Cairo university

  STUDY DIRECTOR

• Mona H Elsherbiny, lecturer

  Anesthesia department , cairo university

  STUDY CHAIR

Central Study Contacts

Abdelmoneim A Abdelmoneim, lecturer

CONTACT

01004392046; abdelmoneim_adel@kasralainy.edu.eg

Marina B Helmy, resident

CONTACT

01270100924; marinabassem49@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Double blinded(the surgeon and the outcome assessor)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: September 24, 2022
• First Posted: September 28, 2022
• Study Start: October 14, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)