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NCT07391475CompletedPhase 4

Ultrasound-Guided Erector Spinae Plane Block Versus Intravenous Nalbuphine

Ultrasound-Guided Erector Spinae Plane Block Versus Intravenous Nalbuphine for Postoperative Analgesia After Video-assisted Thoracoscopy in Obese Patients: A Randomized Controlled Trial of Safety and Effectiveness

Source: ClinicalTrials.gov · Last updated 5 Feb 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
102 (actual)
First submitted
23 Nov 2025
Start date
8 Jul 2025
Primary completion date
7 Jan 2026
Lead sponsor
Zagazig University
Diseases
Obesity
NCT number
NCT07391475

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 102
  • From 8 Jul 2025 to the primary completion date, 7 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • chronic pain with regular use of either opioids or gabapentinoids during the 2 weeks before surgery

Other illness

  • history of thoracic surgery on the same side
  • suffering from any bleeding 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)

Other

  • BMI \<30 or \> 40 kg/ m2
  • anticipated high risk of conversion to thoracotomy
  • taking anticoagulation
  • pregnancy

Who the study is looking for

  • American Society of Anesthesiologist (ASA) status of II and III,
  • age between 21 years and 60 years
  • BMI (body mass index) between 30 and 40 kg/ m2

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ZagazigU
Coordinator of this site? Confirm its status
ZagazigEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.