Peri-anal Local Anaesthetic Infiltration Versus Caudal Anaesthesia in Hirschsprung's Disease.

• ClinicalTrials.gov Identifier: NCT04367818
• Recruitment Status: Not yet recruiting
• First Posted: April 29, 2020
• Last Update Posted: May 6, 2020
• Sponsor: Assiut University
• Information provided by (Responsible Party): Mohamed Salah Rashed Abd Elraheem, Assiut University

Tracking Information

• First Submitted Date: April 27, 2020
• First Posted Date: April 29, 2020
• Last Update Posted Date: May 6, 2020
• Estimated Study Start Date: September 2020
• Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 27, 2020)

Post-operative pain relieve [ Time Frame: 24 hours ]

Evaluation of post-operative pain relieve between perianal block and caudal block by using FLACC score.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Peri-anal Local Anaesthetic Infiltration Versus Caudal Anaesthesia in Hirschsprung's Disease.
• 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.
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Supportive Care
• Condition: Analgesia

Intervention

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

Study Arms

• Active Comparator: Peri-anal local anaesthetic infiltration
  Intervention: Procedure: Peri-anal local anaesthetic infiltration
• Active Comparator: caudal anaesthesia
  Intervention: Procedure: Peri-anal local anaesthetic infiltration

Publications *

• de Beer DA, Thomas ML. Caudal additives in children--solutions or problems? Br J Anaesth. 2003 Apr;90(4):487-98. Review.
• Gopal DV. Diseases of the rectum and anus: a clinical approach to common disorders. Clin Cornerstone. 2002;4(4):34-48. Review.
• 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.
• 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.
• Nyström PO, Derwinger K, Gerjy R. Local perianal block for anal surgery. Tech Coloproctol. 2004 Mar;8(1):23-6.
• 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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 27, 2020): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2022
• Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Years to 10 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Esam Abdalla, Assistant Professor; 01009633737; esamel_deen@yahoo.com

Contact: Mahmoud AbdElazeez, Professor; 01097717172

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04367818
• Other Study ID Numbers: PALAIVCA
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Mohamed Salah Rashed Abd Elraheem, Assiut University
• Study Sponsor: Assiut University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assiut University
• Verification Date: April 2020