Dexmedetomidine Added to Bupivacaine for ESP Block in Children Undergoing Lower Abdominal Surgeries

NCT07023991 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: FMASU MS113/2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of adding dexmedetomidine to bupivacaine in erector spinae plane (ESP) blocks on the duration of postoperative analgesia in pediatric patients undergoing lower abdominal surgery. Effective postoperative pain control in children remains a clinical challenge, and regional anesthesia techniques such as the ESP block have shown promise in improving outcomes. In this randomized, double-blind clinical trial, pediatric patients scheduled for elective lower abdominal surgeries will be assigned to receive either bupivacaine alone or bupivacaine combined with dexmedetomidine as part of an ultrasound-guided ESP block. The primary outcome is the duration of postoperative analgesia, defined as the time from the block until the first request for rescue analgesia. Secondary outcomes include total analgesic consumption and postoperative pain scores

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

• Duration of Postoperative Analgesia

  Measurement of the time from recovery of anesthesia to the need of first given dose of rescue analgesia.

  Up to 24 hours after surgery

Secondary Outcomes (4)

• Postoperative Pain Scores

  At 1, 2, 4, 6, 12, and 24 hours after surgery

• Total intraoperative analgesics

  During the operation from the induction of anesthesia until the recovery.

• Total Postoperative Analgesic Consumption

  Within 24 hours postoperatively

• Incidence of Adverse Effects

  Within 24 hours postoperatively

Study Arms (2)

Bupivacaine Group

ACTIVE COMPARATOR

Patients in this group will receive an ultrasound-guided erector spinae plane (ESP) block with bupivacaine only.

Drug: Bupivacaine

Bupivacaine + Dexmedetomidine Group

EXPERIMENTAL

Patients in this group will receive an ultrasound-guided erector spinae plane (ESP) block with a combination of bupivacaine and dexmedetomidine.

Drug: Bupivacaine; Drug: Dexmedetomidine

Interventions

Bupivacaine DRUG

Bupivacaine will be used in an ESP block to provide postoperative analgesia.

Also known as: Marcaine

Bupivacaine + Dexmedetomidine Group; Bupivacaine Group

Dexmedetomidine DRUG

Dexmedetomidine will be added to bupivacaine in the ESP block to evaluate its effect on duration of postoperative analgesia.

Also known as: Precedex

Bupivacaine + Dexmedetomidine Group

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients aging 1-7 years old of both sexes.
• Patients scheduled for unilateral or bilateral lower abdominal surgeries.
• American Society of Anesthesiologists (ASA) Physical Status Class I, II

You may not qualify if:

• Parents or legal guardian refusal of participation in the study.
• Contraindication to regional anesthesia (including coagulopathy and local infection).
• History or known allergy to local anesthetics.
• Past history of any complications related to the block. (including hematoma and intravascular injection)
• Spinal anomalies altered mental status, a history of developmental delay.
• Additional surgical procedures at different surgical sites.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt, 11865, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ahmed G Nowar, MBBCH

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 17, 2025
• Study Start: May 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before 1/2026
• Access Criteria: Free

Locations

EG (1)