Evaluation of Adding Magnesium Sulfate to (Fentanyl/Bupivacaine)Bi-mixture in Caudal Block

NCT06162806 | Completed

• 1 other identifier: MS-454-2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

this is a randomized controlled study ,patients will be randomly divided into 2 groups , Group A will receive caudal block using 1ml/kg Bupivacaine +0.5u/kg fentanyl, Group B will receive caudal block 50 mg magnesium sulfate added to (1ml/kg Bupivacaine +0.5u/kg fentanyl)

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• time to first requirement of rescue analgesia

  the time after the operation when the patient need rescue analgesia

  24 hours

Secondary Outcomes (2)

• postoperative opioid analgesia consumption

  24 hours

• complications

  24 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

This group of patients will receive ultrasound guided caudal epidural block using 1ml/kg of Bupivacaine +0.5ulkg fentanyl

Procedure: ultrasound guided caudal epidural block using 1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl

Group B

EXPERIMENTAL

This group of patients will receive ultrasound guided caudal epidural block with 50 mg of magnesium added to (1ml/kg Bupivacaine+0.5ulkg fentanyl)bi-mixture

Procedure: ultrasound guided caudal epidural block using 50 mg of Magnesium sulfate added to(1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl)

Interventions

ultrasound guided caudal epidural block using 1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl PROCEDURE

injection of local anesthetic mixture(Bupivacaine +Fentanyl ) in the caudal epidural space under guidance of ultrasound, it is performed by inserting a needle through the sacral hiatus to gain entrance into the sacral epidural space

Group A

ultrasound guided caudal epidural block using 50 mg of Magnesium sulfate added to(1ml/kg of Bupivacaine 0.25% + 0.5microgram/kg of Fentanyl) PROCEDURE

injection of local anesthetic mixture(Bupivacaine +Fentanyl +magnesium sulfate) in the caudal epidural space under guidance of ultrasound, it is performed by inserting a needle through the sacral hiatus to gain entrance into the sacral epidural space

Group B

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• pediatric patients aging from 2-12 years
• undergoing lower abdominal urological surgeries not exceeding 3 hours
• ASA I and II

You may not qualify if:

• parents refusal to participate in the study
• deformities in the spine
• coagulopathy
• localized infection at site of needle insertion
• known allergic to any of the used drugs

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ahmed H Farouk, lecturer

  Anesthesia department , cairo university

  STUDY DIRECTOR

• sherif M soaida, assprofessor

  Anesthesia department , Cairo university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: December 8, 2023
• Study Start: December 14, 2023
• Primary Completion: February 27, 2024
• Study Completion: March 6, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)