NCT07240064

Brief Summary

Laparoscopic abdominal surgeries are frequently performed in pediatric patients and are often associated with significant postoperative pain, which, if inadequately managed, may delay recovery and increase the risk of chronic pain. Optimal analgesia is therefore essential. Regional anesthesia techniques have gained prominence for their ability to provide targeted pain relief, reduce systemic analgesic requirements, and improve recovery outcomes. Among these, the MTAPA through the Perichondral Approach (MTAPA) and the ESPB have attracted attention for potential pediatric use. MTAPA, a refinement of the traditional TAPA, targets thoracoabdominal and lower intercostal nerves, offering effective abdominal wall analgesia. Its perichondral approach aims to enhance local anesthetic spread, potentially improving postoperative pain control. ESPB involves depositing local anesthetic between the erector spinae muscle and vertebral transverse processes, producing analgesia through dorsal and ventral rami blockade. Though widely applied in various surgeries, its role in pediatric laparoscopic abdominal procedures is less studied. MTAPA covers a broader dermatomal range than techniques such as the Transversus Abdominis Plane (TAP) or Oblique Subcostal TAP block, particularly for anterior dermatomes, though most adult reports note coverage between T6-T12. Both MTAPA and ESPB have shown promise in adults, yet their comparative efficacy in pediatric laparoscopic abdominal surgeries remains unclear. This study aims to address this knowledge gap. Therefore, this study aimed to compare the effectiveness of the ESPB and the MTAPA in providing postoperative analgesia for pediatric patients undergoing laparoscopic abdominal surgeries. The study was prospective randomized double blinded comparative and was conducted on 50 patients. They were divided into two equal groups: group (A): they received MTAPA block after induction of GA and group (B): they received ESPB after induction of GA. The study will be double blinded in which the patients, and outcome assessors involved will be blinded to the study allocation and outcomes. Patients received GA induction via propofol 1.5-2.5 mg/kg, fentanyl 1 µg/kg and the maintenance dose were sevoflurane 2%, Tracrium 0.03 mg/kg.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

May 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

September 22, 2025

Last Update Submit

November 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to first analgesic request (hours)

    Time to first analgesic request (hours)

    24 hours

Secondary Outcomes (1)

  • Secondary outcome

    24 hours

Study Arms (2)

Erector spinae plane block

ACTIVE COMPARATOR
Procedure: Erector Spinae Plane Block

Modified thoracoabdominal plane block

ACTIVE COMPARATOR
Procedure: Modified thoracoabdominal plane block

Interventions

Patients were placed in the lateral decubitus position for block performance. The probe in a sterile sleeve was applied 1-2 cm lateral to the Patients and Methods 44 midline to identify the 11-transverse process by counting upward from the sacrum region. After identifying the erector spinae muscle and transverse processes, a 22- gauge, 50 mm nerve block needle were advanced into the target interfacial plane in the craniocaudal direction using the in-plane technique. After confirming the needle placement, 0.4 ml/kg bupivacaine 0.25% were injected. ESPB was considered successful by the linear spread craniocaudally between the tip of the transverse process and the erector spinae muscle. The same process was repeated for the other side.

Erector spinae plane block

The patient was positioned in a supine posture. A deep angle was given to the costochondral angle at the edge of the 10th costa with the probe in the sagittal direction to view the lower surface of the costal cartilage in the midline. A 22-G, 50-mm block needle was inserted in the cranial direction using the in-plane technique and the needle tip was moved to the posterior aspect of the 10th costal cartilage. It was noted that the needle tip never crossed the cranial edge of the 10th costal cartilage and 0.4 ml/kg bupivacaine 0.25% were injected into the lower surface of the chondrium. The same process will be repeated for the other side.

Modified thoracoabdominal plane block

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age from 2 to 7 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I and II.
  • Patients undergoing elective laparoscopic abdominal surgeries under general anesthesia.

You may not qualify if:

  • Known allergies to local anesthetics.
  • Pre-existing chronic pain conditions.
  • Significant hepatic or renal dysfunction.
  • Patients with upper airway infection 2 weeks ago.
  • History of developmental delays, mental retardation, or CNS disease.
  • Congenital spine anomaly.
  • Patients with bleeding and coagulation disorders (e.g., platelet count \<100,000/mm³, INR \> 1.5).
  • Contraindications to regional anesthesia (

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Cairo Governorate, 12345, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor mahmoud abdeltawab mahmoud lectrer of anesthesia

Study Record Dates

First Submitted

September 22, 2025

First Posted

November 20, 2025

Study Start

May 1, 2025

Primary Completion

September 15, 2025

Study Completion

September 15, 2025

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

All ipd will be shared

Shared Documents
STUDY PROTOCOL

Locations