Ultrasound-Guided Erector Spinae Plane Block Versus Intravenous Nalbuphine

NCT07391475 | Completed Phase 4

• 1 other identifier: IRB#5386/ 8-7-2025
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

: Erector Spinae Plane Block, VATS

Outcome Measures

Primary Outcomes (1)

• Time to first rescue analgesia during the first 24 hours postoperative using Verbal Numerical Rating Scale (VNRS)

  Verbal Numerical Rating Scale (VNRS) is a clinical tool used to assess the intensity of pain by categorizing patient responses into ordered descriptive terms such as "no pain," "mild," "moderate," or "severe When VNRS was more than 3, at that time we will give rescue nalbuphine in a dose of 5 mg

  6 months

Study Arms (2)

group A

ACTIVE COMPARATOR

received ultrasound-guided Erector Spinae Plane Block (ESPB) in addition to multimodal analgesia

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

group B

NO INTERVENTION

who received conventional postoperative intravenous analgesia in the form of nalbuphine without ESPB (control group).

Interventions

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

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.

Also known as: Erector spinae plane block

group A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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)
• pregnancy

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

ZagazigU

Zagazig, Zagazig, 055, Egypt

Location

Related Publications (1)

• 1- Kaplowitz J, Papadakos PJ. Acute pain management for video-assisted thora-coscopic surgery: an update. J Cardiothorac Vasc Anesth. 2012;26(2):312-21. 2- Tulgar, S., Kapakli, M. S., Senturk, O., Selvi, O., Serifsoy, T. E., & Ozer, Z. (2018). Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: a prospective, randomized, controlled clinical trial. Journal of Clinical Anesthesia, 49, 101-106. 3- Forero M, Adhikary SD, López H, Tsui C, Chin KJ (2016). The erector spinae plane block novel analgesic technique in thoracic neuropathic pain. Reg Anesth Pain Med.;41(5):621-7.

  BACKGROUND

MeSH Terms

Interventions

Parapsychology; Dental Occlusion; Bupivacaine

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• ahmed M beniamen, MD

  zgazig university hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: February 5, 2026
• Study Start: July 8, 2025
• Primary Completion: January 7, 2026
• Study Completion: January 7, 2026
• Last Updated: February 5, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 21-11-2025 to 20-11-2026
• Access Criteria: WHO zagazig university hospitals

Locations

EG (1)