Ventral HerniaNCT07163026
Comparison of Two Plane Blocks Used in Open Ventral Hernia Repair Operations
A study testing Erector Spine Plane Block and External Oblique - Intercostal Plane Block in people with Ventral Hernia and Postoperative Pain, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ventral Hernia, Postoperative Pain, Postoperative Nausea
- What is being tested?
- Erector Spine Plane Block and External Oblique - Intercostal Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Ataturk Sanatorium Research and Training Hospital
Ankara, 06290
Mustafa Ozgur CIRIK, Assoc. Prof., 90 312 567 70 00 ext. 2031, dr.ozgurr@outlook.com
About this study
Official title: Comparison of Analgesic Efficacy of Erector Spinae Plane Block and External Oblique-Intercostal Plane Block in Patients Undergoing Open Ventral Hernia Repair
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.
- Being tested
- Erector Spine Plane Block, External Oblique - Intercostal Plane Block
- Keywords
- erector spinae plane block, external oblique intercostal plane block, bupivacain
- Medical subject headings
- Hernia, Ventral, Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spine Plane BlockProcedure or 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 BlockProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| ESPB Group | Active comparator | Erector spinae plane block will be applied to the patients in this group. Receives: Procedure: Erector Spine Plane Block |
| EOIPB Group | Sham comparator | External Oblique - Intercostal Plane block will be applied to the patients in this group. Receives: Procedure: External Oblique - Intercostal Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tramadol Consumption
The primary endpoint of the study was whether tramadol consumption in the first 24 hours was significantly different between groups.
Measured: 24 hours
Secondary outcomes (1)
Remifentanil Consumption
The amount of remifentanil consumption required to maintain normal vital signs during the intraoperative period.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Munire BABAYIGIT, Ankara Ataturk Sanatorium Training and Research Hospital
- Investigators
- Munire BABAYIGIT, Assoc. Prof., Study director, Ankara Ataturk Sanatorium Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163026
- Sponsor's protocol ID
- SanatoryumEAH-AK-02
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27501016Kwon 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 32439926Abu 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 30801359Sorenstua 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 38811911Elsharkawy 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy of Erector Spinae Plane Block and External Oblique-Intercostal Plane Block in Patients Undergoing Open Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT07163026
- Acronym / sponsor ID
- SanatoryumEAH-AK-02
- Keywords
- erector spinae plane block, external oblique intercostal plane block, bupivacain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB Group | Active comparator | Procedure: Erector Spine Plane BlockErector spinae plane block will be applied to the patients in this group. |
| EOIPB Group | Sham comparator | Procedure: External Oblique - Intercostal Plane BlockExternal Oblique - Intercostal Plane block will be applied to the patients in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spine Plane BlockBilateral 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. | Procedure or surgery | ESPB Group |
| External Oblique - Intercostal Plane BlockBilateral 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. | Procedure or surgery | EOIPB Group |
Primary outcome
Tramadol Consumption
Time frame: 24 hours
The primary endpoint of the study was whether tramadol consumption in the first 24 hours was significantly different between groups.
1 secondary outcome
Remifentanil Consumption
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Background: PubMed 27501016Forero 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.
- Background: PubMed 32439926Kwon 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.
- Background: PubMed 30801359Abu 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.
- Background: PubMed 38811911Sorenstua 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.
- Background: PubMed 34626112Elsharkawy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Munire BABAYIGIT, Assoc. Prof. study director
Ankara Ataturk Sanatorium Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spine Plane Block and External Oblique - Intercostal Plane Block in people with Ventral Hernia and Postoperative Pain, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali KOC, MD (90 312 567 70 00 ext. 1332, alikoc.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tramadol Consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07163026, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.