ClinicalTrials.gg
Not yet recruitingNCT07163026Updated Sep 16, 2025

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

An interventional study of Erector Spine Plane Block and External Oblique - Intercostal Plane Block in Ventral Hernia, Postoperative Pain and Postoperative Nausea, sponsored by Ankara Ataturk Sanatorium Training and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Ankara Ataturk Sanatorium Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Ventral Hernia
  • Postoperative Pain
  • Postoperative Nausea
  • Postoperative Vomiting

Keywords

  • erector spinae plane block
  • external oblique intercostal plane block
  • bupivacain
03

In context

Hernia, Ventral

230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.

This study's planned enrollment of 50 is below the median of 90 across 153 interventional studies indexed under Hernia, Ventral.

Browse Hernia, Ventral studies →

Lead sponsor

Ankara Ataturk Sanatorium Training and Research Hospital is the lead sponsor of 38 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients scheduled for open ventral hernia repair under general anesthesia
  • Patients with ASA scores () 1 and 2
  • Patients with a between 18.5 and 34.9

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    ESPB Group

    Erector spinae plane block will be applied to the patients in this group.

    Procedure: Erector Spine Plane Block

  • Sham comparator
    EOIPB Group

    External Oblique - Intercostal Plane block will be applied to the patients in this group.

    Procedure: External Oblique - Intercostal Plane Block

Interventions

  • ProcedureErector Spine Plane Block

    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.

  • ProcedureExternal Oblique - Intercostal Plane Block

    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.

06

What researchers measure

Primary outcomes

  1. 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

  1. Remifentanil Consumption

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

    Time frame: 1 hour

Other outcomes

  1. 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

  2. Additional Analgesia

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

    Time frame: 24 hours

  3. 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

  4. Gas and Stool

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

    Time frame: 24 hours

  5. Pittsburgh Sleep Quality Index score

    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.

    Time frame: 24 hours

07

Study locations

1 site
08

References and documents

Publications

  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. PubMed 27501016 ↗
  • Kwon HM, Kim DH, Jeong SM, Choi KT, Park S, Kwon HJ, Lee JH. Does Erector Spinae Plane Block Have a Visceral Analgesic Effect?: A Randomized Controlled Trial. Sci Rep. 2020 May 21;10(1):8389. doi: 10.1038/s41598-020-65172-0. PubMed 32439926 ↗
  • Abu Elyazed MM, Mostafa SF, Abdelghany MS, Eid GM. Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Open Epigastric Hernia Repair: A Prospective Randomized Controlled Study. Anesth Analg. 2019 Jul;129(1):235-240. doi: 10.1213/ANE.0000000000004071. PubMed 30801359 ↗
  • Sorenstua M, Raeder J, Vamnes JS, Leonardsen AL. Evaluation of the Erector spinae plane block for postoperative analgesia in laparoscopic ventral hernia repair: a randomized placebo controlled trial. BMC Anesthesiol. 2024 May 29;24(1):192. doi: 10.1186/s12871-024-02566-x. PubMed 38811911 ↗
  • Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296. PubMed 34626112 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07163026
Lead sponsor
Ankara Ataturk Sanatorium Training and Research Hospital
Responsible party
Munire BABAYIGIT (Associate Professor, Ankara Ataturk Sanatorium Training and Research Hospital) — Principal investigator
First posted
Sep 9, 2025
Start date
Sep 30, 2025 (estimated)
Primary completion
Nov 15, 2025 (estimated)
Completion
Dec 15, 2025 (estimated)
Last update
Sep 16, 2025

Study contacts

Ali KOC, MD
Contact
alikoc.md@gmail.com
90 312 567 70 00 ext. 1332
Munire BABAYIGIT, Assoc. Prof.
Contact
munire.babayigit@sbu.edu.tr
90 312 567 70 00 ext. 2031
Munire BABAYIGIT, Assoc. Prof.
study director · Ankara Ataturk Sanatorium Research and Training Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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