Could Peri-anal Block be Effective as Caudal Block in Trans-anal Pull-through Surgery ??.

Not Applicable

• Conditions: Analgesia
• Interventions: Procedure: Peri-anal local anaesthetic infiltration; Procedure: Caudal anaesthesia

• Registration Number: NCT04367818
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-29
• Study Start: 2021-06-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-23
• Primary Completion: 2022-06-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peri-anal local anaesthetic infiltration	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.
caudal anaesthesia	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).

Primary Outcome Measures

Name	Time	Method
Post-operative pain relieve	24 hours	Assessment of postoperative pain using FLACC scale and the time to first analgesia request.

Secondary Outcome Measures

Name	Time	Method
Ramsay's sedation scale	24 hours	Assessment of postoperative sedation using (Ramsay's sedation scale).
Postoperative Complication	24 hours	Assessment of postoperative Complication (nausea, vomiting, bradycardia with heart rate\< 80 or hypotension as systolic blood pressure\< {70+age in year \*2}).
Postoperative motor power	24 hours	Assessment of postoperative motor power.

Trial Locations

Locations (1)

Mohamed Salah Rashed; 🇪🇬 Assiut, Egypt