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

ConditionsVentral Hernia Postoperative Pain Postoperative Nausea Postoperative Vomiting

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorAnkara Ataturk Sanatorium Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Erector Spine Plane Block
Procedure/Surgery
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/Surgery
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.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: ESPB GroupActive comparator 1 intervention

Group B: EOIPB GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

Tramadol Consumption

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

Time frame

24 hours

Secondary outcomes

Remifentanil Consumption

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

Time frame

1 hour

Other outcomes

Pain Scores

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.

Time frame

24 hours

Additional Analgesia

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

Time frame

24 hours

Nausea and Vomiting

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.

Time frame

24 hours

Gas and Stool

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

Time frame

24 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ankara Ataturk Sanatorium Training and Research Hospital

Lead sponsor

Source ClinicalTrials.gov

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