NCT07666334

Brief Summary

This study aims to compare ultrasound guided subtransverse process interligamentary plane block versus rhomboid intercostal block combined with sub-serratus plane block for postoperative analgesia in pediatric thoracotomy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress46%
Sep 2025Sep 2027

Study Start

First participant enrolled

September 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 18, 2026

Last Update Submit

June 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to first rescue analgesia

    Time to the first rescue analgesia will be recorded from the end of surgery till first dose of morphine adminstrated.

    24 hours postoperatively

Secondary Outcomes (3)

  • Degree of pain

    24 hours postoperatively

  • Total Opioids consumption

    24 hours postoperatively

  • Intraoperative fentanyl consumption

    Intraoperatively

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Patients will receive no block intervention and standard intravenous analgesia will be given.

Other: Standard intravenous analgesia

STIL block

EXPERIMENTAL

Patients will receive ipsilateral ultrasound-guided subtransverse process interligamentary (STIL) plane block with bupivacaine 0.25% (0.5 mL/kg) after induction of general anesthesia.

Other: Subtransverse process interligamentary plane block

RISS block group

EXPERIMENTAL

Patients will receive ipsilateral ultrasound-guided rhomboid intercostal block (RIB) combined with sub-serratus plan block group with bupivacaine 0.25% (0.5mL/kg) after induction of general anesthesia.

Other: Rhomboid intercostal block (RIB) combined with sub-serratus plan block group

Interventions

Patients will receive no block intervention and standard intravenous analgesia will be given.

Control Group

Patients will receive ipsilateral ultrasound-guided subtransverse process interligamentary (STIL) plane block with bupivacaine 0.25% (0.5 mL/kg) after induction of general anesthesia.

STIL block

Patients will receive ipsilateral ultrasound-guided rhomboid intercostal block (RIB) combined with sub-serratus plan block group with bupivacaine 0.25% (0.5mL/kg) after induction of general anesthesia.

RISS block group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients between 6 to 12 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) Physical Status I - II.
  • Scheduled for thoracic surgery with thoracotomy incision under general anesthesia.

You may not qualify if:

  • Parents who refused regional anesthesia.
  • Patients were presented with advanced kidney, cardiac or liver diseases.
  • Coagulation and bleeding disorders.
  • Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
  • Patients with cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Walaa A Elbialy, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management, Faculty of Medicine, Tanta University, Egypt.

Study Record Dates

First Submitted

June 18, 2026

First Posted

June 24, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

June 24, 2026

Record last verified: 2026-06

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