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Ultrasound-Guided Erector Spinae Plane Block Versus Intravenous Nalbuphine

NCT07391475 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-02-05

No results posted yet for this study

Summary

2.1. Study population and setting: This prospective, randomized, controlled clinical trial will be conducted at the thoracic surgery operation room, cardiothoracic surgery building, Zagazig University Hospitals, from July 2025 to December 2025.

Our study included 102 patients who are planned for video-assisted thoracoscopy. Cases will randomly divided into two groups: Erector Spinae Plane Block (ESPB) and the control group, comprising 51 patients each. Inclusion criteria also include: American Society of Anesthesiologist (ASA) status of II and III, age between 21 years and 60 years, and BMI (body mass index) between 30 and 40 kg/ m2. Patients who will be excluded from the present study included: BMI \<30 or \> 40 kg/ m2, chronic pain with regular use of either opioids or gabapentinoids during the 2 weeks before surgery, history of thoracic surgery on the same side, anticipated high risk of conversion to thoracotomy, taking anticoagulation, suffering from any bleed¬ing disorders, known allergy to local anesthetics, nalbuphine or fentanyl, active infection at the injection site, pre-existing neurological or psychiatric illness, severe cardiovascular disease, liver failure, renal failure (estimated glomerular filtration rate less than 15 ml min), and pregnancy.

Patients will be also excluded after randomiza¬tion if they have converted to thoracot¬omy, severe intra- or postoperative blood loss \>1000cc, required postoperative mechanical ventilation, or a technical difficulty in the ESPB performance.

2.2. Randomization and allocation Patients will be randomized in a one-to-one ratio and assigned to either the ESPB (group A) or control group (group B) (Fig. 1). Randomization allocations will be kept in sealed opaque covers and only opened by the investigator immediately prior to the ESPB, which will be performed in a holding area before entry into the block rooms. All blocks will be performed by the same anesthetist using the linear probe of an Ultrasound machine (GE Vivid E95).

Conditions

  • Postoperative Pain Management

Interventions

PROCEDURE

Erector Spinae (ESP) Block with Bupivacaine (Marcaine®)

Scanning was done in the longitudinal plane 3 cm parasagittal from the midline on the operated side, as defined by Forero et al. 2016. The tip of the T6 transverse process was identified by progressively downgrading from C7. When the T6 transverse process was in the middle of the image and the pleura were visualized, the A22-gauge, 80mm needle was inserted in-plane and guided to the middle of the transverse process of T6 in a cephalad- caudad direction until the tip of the needle was placed into the fascial plane on the deep aspect of the erector spinae muscle.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • ahmed M beniamen, MD · zgazig university hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-08
Primary Completion
2026-01-07
Completion
2026-01-07

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07391475 on ClinicalTrials.gov