Could Peri-anal Block be Effective as Caudal Block in Trans-anal Pull-through Surgery ??.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2020
CompletedStudy Start
First participant enrolled
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedAugust 23, 2021
August 1, 2021
11 months
April 27, 2020
August 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative pain relieve
Assessment of postoperative pain using FLACC scale and the time to first analgesia request.
24 hours
Secondary Outcomes (3)
Ramsay's sedation scale
24 hours
Postoperative motor power
24 hours
Postoperative Complication
24 hours
Study Arms (2)
Peri-anal local anaesthetic infiltration
ACTIVE COMPARATORPatients in this group will receive the prepared anesthetic mixture (bupivacaine 0.25% in dose of 1ml\\kg plus dexametomidine 2ug\\kg diluted in 0.5ml of normal saline) in a syringe will be connected to 22\_ gauge short, beveled needle. The technique of the block will be done guided by Nystrom et al.
caudal anaesthesia
ACTIVE COMPARATORPatients in this group will receive caudal block using 22\_gauge short, beveled cannula or needle, The prepared anesthetic mixture (bupivacaine 0.25% in dose of 1ml\\kg plus dexametomidine 2ug\\kg diluted in 0.5ml of normal saline).
Interventions
postoperative pain relieve, among pediatrics patient
Regional anaesthesia for postoperative pain relieve, among pediatrics patient
Eligibility Criteria
You may qualify if:
- Patients of both sexes.
- Patients with age range 3 to 10 years old.
- Patients with ASA 1 , 2 classification.
You may not qualify if:
- Patient or parents refusal.
- Allergy to the study drugs.
- Suspect coagulopathy.
- Local infection at site of intervention.
- History of developmental delay.
- Neuromuscular disorders.
- Skeletal deformity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mohamed Salah Rashed
Asyut, Egypt
Related Publications (8)
de Beer DA, Thomas ML. Caudal additives in children--solutions or problems? Br J Anaesth. 2003 Apr;90(4):487-98. doi: 10.1093/bja/aeg064. No abstract available.
PMID: 12644422BACKGROUNDGopal DV. Diseases of the rectum and anus: a clinical approach to common disorders. Clin Cornerstone. 2002;4(4):34-48. doi: 10.1016/s1098-3597(02)90004-9.
PMID: 12739325BACKGROUNDGabrielli F, Cioffi U, Chiarelli M, Guttadauro A, De Simone M. Hemorrhoidectomy with posterior perineal block: experience with 400 cases. Dis Colon Rectum. 2000 Jun;43(6):809-12. doi: 10.1007/BF02238019.
PMID: 10859082BACKGROUNDLuck AJ, Hewett PJ. Ischiorectal fossa block decreases posthemorrhoidectomy pain: randomized, prospective, double-blind clinical trial. Dis Colon Rectum. 2000 Feb;43(2):142-5. doi: 10.1007/BF02236970.
PMID: 10696885BACKGROUNDNystrom PO, Derwinger K, Gerjy R. Local perianal block for anal surgery. Tech Coloproctol. 2004 Mar;8(1):23-6. doi: 10.1007/s10151-004-0046-8.
PMID: 15057585BACKGROUNDKaban OG, Yazicioglu D, Akkaya T, Sayin MM, Seker D, Gumus H. Spinal anaesthesia with hyperbaric prilocaine in day-case perianal surgery: randomised controlled trial. ScientificWorldJournal. 2014;2014:608372. doi: 10.1155/2014/608372. Epub 2014 Oct 14.
PMID: 25379541BACKGROUNDZhang Y, Bao Y, Li L, Shi D. The effect of different doses of chloroprocaine on saddle anesthesia in perianal surgery. Acta Cir Bras. 2014 Jan;29(1):66-70. doi: 10.1590/S0102-86502014000100010.
PMID: 24474180BACKGROUNDAnannamcharoen S, Cheeranont P, Boonya-usadon C. Local perianal nerve block versus spinal block for closed hemorrhoidectomy: a ramdomized controlled trial. J Med Assoc Thai. 2008 Dec;91(12):1862-6.
PMID: 19133521BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 27, 2020
First Posted
April 29, 2020
Study Start
June 30, 2021
Primary Completion
June 1, 2022
Study Completion
August 1, 2022
Last Updated
August 23, 2021
Record last verified: 2021-08