Clinical trial NCT04367818: Could Peri-anal Block be Effective as Caudal Block in Trans-anal Pull-through Surgery ??.
Official title: Could Peri-anal Block be Effective as Caudal Block in Trans-anal Pull-through Surgery for Children With Hirschsprung Disease??. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: Inclusion Criteria:

* Patients of both sexes.
* Patients with age range 3 to 10 years old.
* Patients with ASA 1 , 2 classification.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Post-operative pain relieve
timeFrame: 24 hours
Secondary outcomes:
measure: Ramsay's sedation scale
timeFrame: 24 hours
measure: Postoperative motor power
timeFrame: 24 hours
measure: Postoperative Complication
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Mohamed Salah Rashed
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.