The Hemodynamic Effects of Different Volumes of Bupivacaine 0.25% Caudal Blocks in Pediatrics Undergoing Lower Abdominal Surgeries as Measured by Electrical Cardiometry

NCT05133687 | Completed Phase 3

• 1 other identifier: MS-445-2021
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, controlled study is designed to estimate the effects of different volumes of plain bupivacaine 0.25% caudal block on different hemodynamic parameters assessed by electrical cardiometry.

Conditions

Anesthesia, Caudal; Pediatrics

Keywords

pediatrics; caudal anesthesia; hemodynamics; electrical cardiometry; bupivacaine 0.25%

Outcome Measures

Primary Outcomes (1)

• The percentage of change from the baseline measurement of the cardiac index CI 10 minutes after successful caudal block.

  10 minutes after caudal block.

Secondary Outcomes (4)

• Electrical cardiometry cardiac index

  30 minutes

• mean ABP

  1-2 hours

• Incidence of complications: block failure, bradycardia (HR < 80/min) , hypotension (blood pressure <20% of base line) and local anesthesia systemic toxicity (LAST)

  1-2 hours

• heart rate

  1-2 hours

Study Arms (3)

Group (0.8-G)

EXPERIMENTAL

This group will receive general anesthesia and caudal block with 0.8 ml/kg of bupivacaine 0.25%

Drug: Bupivacaine Hydrochloride

Group (1.2-G)

EXPERIMENTAL

This group will receive general anesthesia and caudal block with 1.2 ml/kg of bupivacaine 0.25%

Drug: Bupivacaine Hydrochloride

Group G

ACTIVE COMPARATOR

This group will receive general anesthesia with local infiltration of the wound or transversus abdominis plan block (TAPB) at the end of the procedure.

Drug: Bupivacaine Hydrochloride

Interventions

Bupivacaine Hydrochloride DRUG

Recruited children will be randomly assigned to one of three groups in a 1:1:1 ratio; (Group 0.8-G), (Group 1.2-G) and (Group G).

Group (0.8-G); Group (1.2-G); Group G

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All pediatrics ASA I\&II aged 1-8 years undergoing elective lower abdominal surgeries.

You may not qualify if:

• ASA ≥ III. Parents refusal of caudal block. Patients with coagulation disorders (Platelets ≤ 50,000 and/or INR\> 1.5). Patients with suspected or proved allergic to local anesthetics. Rash or signs of infection at the injection site. Patients requiring emergency or laparoscopic procedures.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo university hospitals, kasralainy

Cairo, 11559, Egypt

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The concealed envelopes will be opened by an anesthesia resident (who will not be involved in patient management) and he will be responsible for preparing and giving the caudal block for the caudal groups as instructed in the envelope. the data will be collected by another anesthetist who is blinded to the group assignment.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator,Lecturer of anesthesia, Cairo university

Model Details: Children will be recruited into the trial during pre-operative assessment. Recruited children will be randomly assigned to one of three groups in a 1:1:1 ratio; (Group 0.8-G) to receive general anesthesia and caudal block with 0.8 ml/kg of bupivacaine 0.25% and (Group 1.2-G) to receive general anesthesia and caudal block with 1.2 ml/kg of bupivacaine 0.25% and (Group G) to receive general anesthesia with local infiltration of the wound or transversus abdominis plan block (TAPB) at the end of the procedure.

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 24, 2021
• Study Start: November 15, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

EG (1)