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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

Tracking Information
First Submitted Date  ICMJE April 27, 2020
First Posted Date  ICMJE April 29, 2020
Last Update Posted Date May 6, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
Post-operative pain relieve [ Time Frame: 24 hours ]
Evaluation of post-operative pain relieve between perianal block and caudal block by using FLACC score.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peri-anal Local Anaesthetic Infiltration Versus Caudal Anaesthesia in Hirschsprung's Disease.
Official Title  ICMJE Peri-anal Local Anaesthetic Infiltration Versus Caudal Anaesthesia for Post-operative Pain Relief in Trans-anal Pull Through Operation for Hirschsprung's Disease.
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Analgesia
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Peri-anal local anaesthetic infiltration
    Intervention: Procedure: Peri-anal local anaesthetic infiltration
  • Active Comparator: caudal anaesthesia
    Intervention: Procedure: Peri-anal local anaesthetic infiltration
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Esam Abdalla, Assistant Professor 01009633737 esamel_deen@yahoo.com
Contact: Mahmoud AbdElazeez, Professor 01097717172
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04367818
Other Study ID Numbers  ICMJE PALAIVCA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mohamed Salah Rashed Abd Elraheem, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP