Could Peri-anal Block be Effective as Caudal Block in Trans-anal Pull-through Surgery ??.
NCT ID: NCT04367818
Last Updated: 2021-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-06-30
2022-08-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Peri-anal local anaesthetic infiltration
Patients 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.
Peri-anal local anaesthetic infiltration
postoperative pain relieve, among pediatrics patient
caudal anaesthesia
Patients 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).
Caudal anaesthesia
Regional anaesthesia for postoperative pain relieve, among pediatrics patient
Interventions
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Peri-anal local anaesthetic infiltration
postoperative pain relieve, among pediatrics patient
Caudal anaesthesia
Regional anaesthesia for postoperative pain relieve, among pediatrics patient
Eligibility Criteria
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Inclusion Criteria
* Patients with age range 3 to 10 years old.
* Patients with ASA 1 , 2 classification.
Exclusion Criteria
* Allergy to the study drugs.
* Suspect coagulopathy.
* Local infection at site of intervention.
* History of developmental delay.
* Neuromuscular disorders.
* Skeletal deformity.
3 Years
10 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mohamed Salah Rashed Abd Elraheem
Principal Investigator
Locations
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Mohamed Salah Rashed
Asyut, , Egypt
Countries
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Central Contacts
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Fatma Nabil, Professor
Role: CONTACT
Facility Contacts
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References
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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.
Gopal 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.
Gabrielli 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.
Luck 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.
Nystrom 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.
Kaban 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.
Zhang 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.
Anannamcharoen 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.
Other Identifiers
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CPABBEACB
Identifier Type: -
Identifier Source: org_study_id
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