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Clinical Trials/NCT07240064
NCT07240064CompletedNot Applicable

Erector Spinae Plane Block Versus Modified Thoracoabdominal Nerve Block for Analgesia in Pediatric Laparoscopic Abdominal Surgeries: a Prospective, Randomized Comparative Study

Cairo University1 site in 1 country50 target enrollmentStarted: May 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Time to first analgesic request (hours)

Study Overview

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.

Detailed Description

This prospective randomized double blinded controlled study was carried out on 50 pediatric patients who scheduled to undergo elective laparoscopic abdominal surgeries admitted to Cairo University Specialized Children Hospital in the duration from …...to…...after the approval of ethical committee. Group M-TAPA (group A) (n=25): Patients received M-TAPA block after induction of GA.

• Group ESPB (group B) (n=25): Patients received ESPB after induction of GA. Patients and outcome assessors were blinded to the group of the patients. A pharmacist who is not involved in the study prepared the interventional medications. Methods

Preoperative assessment:

Medical and surgical history of the patients were taken, clinical examination of the patients was performed and routine laboratory investigations such as CBC, coagulation studies (INR), renal function (serum creatinine) and liver function (SGPT, SGOT) were done. Each patient was instructed about postoperative pain assessment with the Face, Legs, Activity, Cry and Consolability (FLACC) scale. FLACC (0 represents "no pain" while 10 represents "the maximum pain").

Intraoperative:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
2 Years to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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 (

Arms & Interventions

Erector spinae plane block

Active Comparator

Intervention: Erector Spinae Plane Block (Procedure)

Modified thoracoabdominal plane block

Active Comparator

Intervention: Modified thoracoabdominal plane block (Procedure)

Outcomes

Primary Outcomes

Time to first analgesic request (hours)

Time Frame: 24 hours

Time to first analgesic request (hours)

Secondary Outcomes

  • Secondary outcome(24 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Gbre

doctor mahmoud abdeltawab mahmoud lectrer of anesthesia

Cairo University

Study Sites (1)

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