NCT06452225

Brief Summary

The aim of this study is to compare the ultrasound guided TAP Block and EOIP block for postoperative analgesia in pediatrics undergoing open nephrectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

June 12, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

1.4 years

First QC Date

May 30, 2024

Last Update Submit

November 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to the 1st rescue analgesia

    A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 15 mg /kg/8 hrs as routine analgesia. Rescue analgesia of morphine will be given as 0.05 mg/kg if face, legs, activity, and cry consolability scale (FLACC) ≥ 4 and the maximum allowed dose is 0.1mg/kg every 4 hours. FLACC will be assessed at 0, 2, 4, 8, 12 and 24h postoperatively. it will be measured from the end of surgery to first dose of morphine administrated.

    24 hours postoperatively

Secondary Outcomes (4)

  • Intraoperative fentanyl consumption

    Intraoperatively

  • Total morphine consumption

    24 hours postoperatively

  • Degree of pain

    24 hours postoperatively

  • Mean arterial pressure

    Every 15 minutes till the end of surgery

Other Outcomes (1)

  • Heart rate

    Every 15 minutes till the end of surgery

Study Arms (2)

External Oblique Intercostal Plane Block

EXPERIMENTAL

Patients will receive external oblique intercostal plane block.

Other: External Oblique Intercostal Plane Block

Transversus Abdominis Plane Block

EXPERIMENTAL

Patients will receive ultrasound guided transversus abdominis plane block.

Other: Transversus Abdominis Plane Block

Interventions

Patients will receive external oblique intercostal plane block.

External Oblique Intercostal Plane Block

Patients will receive ultrasound guided transversus abdominis plane block.

Transversus Abdominis Plane Block

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age ≤ 18 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I-III.
  • Scheduled for open nephrectomy.

You may not qualify if:

  • Abnormal blood coagulation.
  • Scar, infection, and tumor of puncture site.
  • History or family history of high malignant fever.
  • Severe cardiovascular problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

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
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

May 30, 2024

First Posted

June 11, 2024

Study Start

June 12, 2024

Primary Completion

October 20, 2025

Study Completion

October 20, 2025

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year
Access Criteria
The data will be available upon a reasonable request from the corresponding author

Locations