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

NCT ID: NCT07163026

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2025-12-15

Brief Summary

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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

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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.

Conditions

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Ventral Hernia Postoperative Pain Postoperative Nausea Postoperative Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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ESPB Group

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

Group Type ACTIVE_COMPARATOR

Erector Spine Plane Block

Intervention Type 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.

EOIPB Group

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

Group Type SHAM_COMPARATOR

External Oblique - Intercostal Plane Block

Intervention Type 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.

Interventions

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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 then positioned for surgery.

Intervention Type 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 saline, 30 ml of 0.25% bupivacaine was injected on each side, with craniocaudal spread confirmed by ultrasound. Patients were then positioned for surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Ataturk Sanatorium Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Munire BABAYIGIT

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Munire BABAYIGIT, Assoc. Prof.

Role: STUDY_DIRECTOR

Ankara Ataturk Sanatorium Research and Training Hospital

Locations

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Ankara Ataturk Sanatorium Research and Training Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Ali KOC, MD

Role: CONTACT

90 312 567 70 00 ext. 1332

Munire BABAYIGIT, Assoc. Prof.

Role: CONTACT

90 312 567 70 00 ext. 2031

Facility Contacts

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Mustafa Ozgur CIRIK, Assoc. Prof.

Role: primary

90 312 567 70 00 ext. 2031

References

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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.

Reference Type BACKGROUND
PMID: 27501016 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32439926 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30801359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38811911 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34626112 (View on PubMed)

Other Identifiers

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SanatoryumEAH-AK-02

Identifier Type: -

Identifier Source: org_study_id

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