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

Could Peri-anal Block be Effective as Caudal Block in Trans-anal Pull-through Surgery for Children With Hirschsprung Disease??. A Randomized Controlled Trial.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04367818
Enrollment
60
Registered
2020-04-29
Start date
2021-06-30
Completion date
2022-08-01
Last updated
2021-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

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).

Interventions

PROCEDUREPeri-anal local anaesthetic infiltration

postoperative pain relieve, among pediatrics patient

Regional anaesthesia for postoperative pain relieve, among pediatrics patient

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Post-operative pain relieve24 hoursAssessment of postoperative pain using FLACC scale and the time to first analgesia request.

Secondary

MeasureTime frameDescription
Ramsay's sedation scale24 hoursAssessment of postoperative sedation using (Ramsay's sedation scale).
Postoperative motor power24 hoursAssessment of postoperative motor power.
Postoperative Complication24 hoursAssessment of postoperative Complication (nausea, vomiting, bradycardia with heart rate\< 80 or hypotension as systolic blood pressure\< {70+age in year \*2}).

Countries

Egypt

Contacts

Primary ContactEsam Abdalla, Professor
esamel_deen@yahoo.com01009633737
Backup ContactFatma Nabil, Professor
01003633992

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026