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Not yet recruiting NCT07163026

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

No phase Interventional Ventral Hernia Postoperative Pain Postoperative Nausea Postoperative Vomiting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Erector Spine Plane Block, External Oblique - Intercostal Plane Block.
Who it may be relevant to
Registry conditions: Ventral Hernia, Postoperative Pain, Postoperative Nausea, Postoperative Vomiting. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Procedure Erector 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
  • Procedure External 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

Primary outcome measures

  • Tramadol Consumption [Time frame: 24 hours]
Secondary outcome measures (1)
  • Remifentanil Consumption [Time frame: 1 hour]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Ataturk Sanatorium Research and Training Hospital — Ankara

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 34626112

Identifiers

NCT: NCT07163026 · SanatoryumEAH-AK-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗