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Peri-anal Local Anaesthetic Infiltration Versus Caudal Anaesthesia in Hirschsprung's Disease.

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ClinicalTrials.gov Identifier: NCT04367818
Recruitment Status : Not yet recruiting
First Posted : April 29, 2020
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Salah Rashed Abd Elraheem, Assiut University

Brief Summary:
IN pediatric patient population pain is considered one of the most misunderstood; under diagnosed and under treated medical problems. If left uncontrolled, pain may have a diverse effect on all aspects of life as it is only a sensory perception but also has emotional, cognitive and behavioral components.

Condition or disease Intervention/treatment Phase
Analgesia Procedure: Peri-anal local anaesthetic infiltration Phase 4

Detailed Description:

Caudal anesthesia is one of the most commonly used regional anesthetic and analgesic technique in pediatric patient as it is an easy safe and reliable method that can be performed for both intraoperative and postoperative analgesia in patient undergoing lower abdominal and lower limb surgery. It can be used for upper abdominal surgery by increasing the volume of local anesthetic injected or through advancing a catheter.

Caudal anesthesia is a common practice given along with general anesthesia to decrease intraoperative inhalational anesthesia requirements, postoperative pain and emergence agitation.

So many patients are complaining from ano-rectal pathologies, these diseases are common in both sexes and all age groups. The spectrum of anorectal disorders ranges from benign and irritating (pruritus- ani) to potentially life-threatening (anorectal cancer) and the surgical intervention is performed mostly under general or regional anesthesia.

While general and regional anesthetics provide reliable anesthesia, they are often associated with nausea,vomiting, urinary retention and motor blockade of lower limbs. Moreover, repeated spinal or epidural punctures performed by inexperienced anesthesiologists often cause delays in the tight schedule of operations.

Several reports have described various forms of local anesthetic infiltration for ano- rectal surgery , hemorrhoidectomy,anal fistula or fissure surgeries or lateral sphincterotomy. Local peri-anal infiltration is a simple procedure that can be easily learned and performed by surgeon and this method allows the operation to begin almost immediately.

There are different types of local anesthesia like infiltration, nerve block, ring block field block. Considering anorectal surgeries, nerve bock mainly pudendal nerve along with infiltration anesthesia is used worldwide. Perianal block by local anesthetic infiltration is safe simple and effective for various anal operations with very high degree of acceptance and satisfaction among patients .it had been found to be associated with low pain score and postoperative complications and faster return to daily social activity.

Although there are studies on the use of caudal block and local infiltration of anesthetic agent for the surgical resolution of anorectal pathologies, there is no established protocol for comparing efficacy, postoperative pain, and satisfaction among pediatrics patient undergoing trans-anal pull through in congenital megacolon (Hirschsprung's disease).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Peri-anal Local Anaesthetic Infiltration Versus Caudal Anaesthesia for Post-operative Pain Relief in Trans-anal Pull Through Operation for Hirschsprung's Disease.
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : April 2022


Arm Intervention/treatment
Active Comparator: Peri-anal local anaesthetic infiltration Procedure: Peri-anal local anaesthetic infiltration
Evaluation and comparison between perianal block and caudal block in its efficacy, side effects, and postoperative pain relieve, among pediatrics patient undergoing trans-anal pull through in congenital megacolon (Hirschsprung's disease).
Other Name: caudal anaesthesia

Active Comparator: caudal anaesthesia Procedure: Peri-anal local anaesthetic infiltration
Evaluation and comparison between perianal block and caudal block in its efficacy, side effects, and postoperative pain relieve, among pediatrics patient undergoing trans-anal pull through in congenital megacolon (Hirschsprung's disease).
Other Name: caudal anaesthesia




Primary Outcome Measures :
  1. Post-operative pain relieve [ Time Frame: 24 hours ]
    Evaluation of post-operative pain relieve between perianal block and caudal block by using FLACC score.



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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of both sexes.
  • Pstients with age range 3 to 10 years old.
  • Patients with ASA 1 classification.

Exclusion Criteria:

  • Patient or parents refusal
  • without contraindications for use of local or caudal anesthesia (infection near the site of the needle insertion, coagulopathy, anti-coagulation therapy, pilonidal cyst, congenital anomalies of the lower spine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04367818


Contacts
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Contact: Esam Abdalla, Assistant Professor 01009633737 esamel_deen@yahoo.com
Contact: Mahmoud AbdElazeez, Professor 01097717172

Sponsors and Collaborators
Assiut University
Publications:
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Responsible Party: Mohamed Salah Rashed Abd Elraheem, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04367818    
Other Study ID Numbers: PALAIVCA
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hirschsprung Disease
Digestive System Abnormalities
Digestive System Diseases
Megacolon
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents