Peri-anal Local Anaesthetic Infiltration Versus Caudal Anaesthesia in Hirschsprung's Disease.
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04367818 |
Recruitment Status :
Not yet recruiting
First Posted : April 29, 2020
Last Update Posted : May 6, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Analgesia | Procedure: Peri-anal local anaesthetic infiltration | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Supportive Care |
Official Title: | Peri-anal Local Anaesthetic Infiltration Versus Caudal Anaesthesia for Post-operative Pain Relief in Trans-anal Pull Through Operation for Hirschsprung's Disease. |
Estimated Study Start Date : | September 2020 |
Estimated Primary Completion Date : | October 2021 |
Estimated Study Completion Date : | April 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Peri-anal local anaesthetic infiltration |
Procedure: Peri-anal local anaesthetic infiltration
Evaluation and comparison between perianal block and caudal block in its efficacy, side effects, and postoperative pain relieve, among pediatrics patient undergoing trans-anal pull through in congenital megacolon (Hirschsprung's disease).
Other Name: caudal anaesthesia |
Active Comparator: caudal anaesthesia |
Procedure: Peri-anal local anaesthetic infiltration
Evaluation and comparison between perianal block and caudal block in its efficacy, side effects, and postoperative pain relieve, among pediatrics patient undergoing trans-anal pull through in congenital megacolon (Hirschsprung's disease).
Other Name: caudal anaesthesia |
- Post-operative pain relieve [ Time Frame: 24 hours ]Evaluation of post-operative pain relieve between perianal block and caudal block by using FLACC score.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 3 Years to 10 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients of both sexes.
- Pstients with age range 3 to 10 years old.
- Patients with ASA 1 classification.
Exclusion Criteria:
- Patient or parents refusal
- without contraindications for use of local or caudal anesthesia (infection near the site of the needle insertion, coagulopathy, anti-coagulation therapy, pilonidal cyst, congenital anomalies of the lower spine.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04367818
Contact: Esam Abdalla, Assistant Professor | 01009633737 | esamel_deen@yahoo.com | |
Contact: Mahmoud AbdElazeez, Professor | 01097717172 |
Responsible Party: | Mohamed Salah Rashed Abd Elraheem, Principal Investigator, Assiut University |
ClinicalTrials.gov Identifier: | NCT04367818 |
Other Study ID Numbers: |
PALAIVCA |
First Posted: | April 29, 2020 Key Record Dates |
Last Update Posted: | May 6, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hirschsprung Disease Digestive System Abnormalities Digestive System Diseases Megacolon Colonic Diseases Intestinal Diseases Gastrointestinal Diseases |
Congenital Abnormalities Anesthetics Anesthetics, Local Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |