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

NCT07163026 | Not Yet Recruiting

• 1 other identifier: SanatoryumEAH-AK-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventral Hernia; Postoperative Pain; Postoperative Nausea; Postoperative Vomiting

Keywords

erector spinae plane block; external oblique intercostal plane block; bupivacain

Outcome Measures

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.

  24 hours

Secondary Outcomes (1)

• Remifentanil Consumption

  1 hour

Other Outcomes (5)

• Pain Scores

  24 hours

• Additional Analgesia

  24 hours

• Nausea and Vomiting

  24 hours

Study Arms (2)

ESPB Group

ACTIVE COMPARATOR

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

Procedure: Erector Spine Plane Block

EOIPB Group

SHAM COMPARATOR

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

Procedure: External Oblique - Intercostal Plane Block

Interventions

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.

ESPB Group

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.

EOIPB Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Ataturk Sanatorium Training and Research Hospital: lead

Study Sites (1)

Ankara Ataturk Sanatorium Research and Training Hospital

Ankara, 06290, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 32439926 BACKGROUND

• 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.

  PMID: 30801359 BACKGROUND

• 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.

  PMID: 38811911 BACKGROUND

• 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.

  PMID: 34626112 BACKGROUND

MeSH Terms

Conditions

Hernia, Ventral; Pain, Postoperative; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

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

Study Officials

• Munire BABAYIGIT, Assoc. Prof.

  Ankara Ataturk Sanatorium Research and Training Hospital

  STUDY DIRECTOR

Central Study Contacts

Ali KOC, MD

CONTACT

90 312 567 70 00; alikoc.md@gmail.com

Munire BABAYIGIT, Assoc. Prof.

CONTACT

90 312 567 70 00; munire.babayigit@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Block provider doesn't know peroperative process and the patient's postoperative assesment. Anesthesia provider doesn't know the block type and the patient's postoperative assesment. Outcomes assessor doesn't know about the block type and intraoperative process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: September 30, 2025
• Primary Completion: November 15, 2025
• Study Completion: December 15, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)