Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07163026

Comparison of Two Plane Blocks Used in Open Ventral Hernia Repair Operations

The aim of this study is to compare the postoperative analgesic efficacy of bilateral erector spinae plane block and bilateral external oblique-intercostal plane block in patients undergoing open ventral hernia repair.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea Postoperative Nausea and Vomiting Postoperative Pain Postoperative Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Ataturk Sanatorium Research and Training Hospital

Ankara, 06290, Turkey (Türkiye)

Location contact

Mustafa Ozgur CIRIK, Assoc. Prof.

CONTACT

[email protected]

90 312 567 70 00 ext. 2031

About this study

The effectiveness of trunk blocks applied at equivalent doses will be evaluated in order to most effectively treat postoperative pain, minimize nausea and vomiting, and optimize the comfort of patients during the postoperative period after open ventral hernia repair operations. The methods used in this study are proven safe in ventral hernia repair surgery and other abdominal surgeries, and are routinely performed in our clinic. The procedures performed pose no additional risks to patients compared to routine procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for open ventral hernia repair under general anesthesia
  • Patients with ASA scores (American Society of Anesthesiologists) 1 and 2
  • Patients with a body mass index between 18.5 and 34.9

Exclusion criteria

  • Patients scheduled for open ventral hernia repair under spinal or epidural anesthesia
  • Patients who have previously undergone spine surgery.
  • Patients with known local anesthetic allergy
  • Pregnant women
  • Mentally uncooperative patients
  • Patients with a history of chronic analgesic use

Treatment and study plan

Erector spine plane block

Procedure

Bilateral erector spinae plane block was performed under aseptic conditions at the T7 vertebral level using ultrasound guidance with a convex probe. An 80-mm peripheral nerve block needle was inserted 3-4 cm lateral to the midline with an in-plane approach to the fascial plane deep to the erector spinae muscle. After negative aspiration and hydrodissection with 1-3 ml of saline, 30 ml of 0.25% bupivacaine was injected on each side, with craniocaudal spread confirmed by ultrasound. Patients were then positioned for surgery.

External Oblique - Intercostal Plane Block

Procedure

Bilateral external oblique-intercostal plane block was performed under aseptic conditions by identifying the 6th and 7th ribs along the midclavicular line. Using ultrasound guidance with the probe placed parallel to the midclavicular line, the ribs, intercostal muscles, external oblique muscle, and pleura were visualized. A 50-mm block needle was advanced craniocaudally into the plane between the external oblique and intercostal muscles. After negative aspiration and hydrodissection with 1-3 ml saline, 30 ml of 0.25% bupivacaine was injected on each side, with craniocaudal spread confirmed by ultrasound. Patients were then positioned for surgery.

Primary outcomes

  1. Tramadol Consumption

    Time frame: 24 hours

    The primary endpoint of the study was whether tramadol consumption in the first 24 hours was significantly different between groups.

Secondary outcomes

  1. Remifentanil Consumption

    Time frame: 1 hour

    The amount of remifentanil consumption required to maintain normal vital signs during the intraoperative period.

Other outcomes

  1. Pain Scores

    Time frame: 24 hours

    Difference between pain scores according to Visual Analog Scale at the 2nd and 24th postoperative hours. This scale consists of a 100-millimeter line, with 0 representing no symptoms and 100 representing the most severe symptoms ever experienced. Patients are asked to mark the intensity they feel on the line. A numerical value is then obtained by measuring the millimeter at which the mark appears.

  2. Additional Analgesia

    Time frame: 24 hours

    The time when patients request painkiller for the first time despite their existing analgesia plan.

  3. Nausea and Vomiting

    Time frame: 24 hours

    Nausea and vomiting according to Visual Analog Scale that can be observed at the 2nd and 24th postoperative hours.This scale consists of a 100-millimeter line, with 0 representing no symptoms and 100 representing the most severe symptoms ever experienced. Patients are asked to mark the intensity they feel on the line. A numerical value is then obtained by measuring the millimeter at which the mark appears.

  4. Gas and Stool

    Time frame: 24 hours

    Time to pass gas or stool for the first time in the postoperative period.

  5. Pittsburgh Sleep Quality Index score

    Time frame: 24 hours

    Evaluation of patients' sleep in the last month according to the Pittsburgh Sleep Quality Index score. The Pittsburgh Sleep Quality Index consists of seven components, each scored 0-3, yielding a global score of 0-21. Higher scores reflect poorer sleep quality, with a global score >5 indicating clinically significant sleep disturbance.

Study contacts

Contact information is provided by the study sponsor or research team.

Ali KOC, MD

CONTACT

[email protected]

90 312 567 70 00 ext. 1332

Munire BABAYIGIT, Assoc. Prof.

CONTACT

[email protected]

90 312 567 70 00 ext. 2031

Sponsors and collaborators

Lead sponsor

Ankara Ataturk Sanatorium Training and Research Hospital

Other Gov

Registry information

Official study title

Comparison of Analgesic Efficacy of Erector Spinae Plane Block and External Oblique-Intercostal Plane Block in Patients Undergoing Open Ventral Hernia Repair

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 9, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.