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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESPB Group | Active Comparator | Erector spinae plane block will be applied to the patients in this group. |
|
| EOIPB Group | Sham Comparator | External Oblique - Intercostal Plane block will be applied to the patients in this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tramadol Consumption | The primary endpoint of the study was whether tramadol consumption in the first 24 hours was significantly different between groups. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Remifentanil Consumption | The amount of remifentanil consumption required to maintain normal vital signs during the intraoperative period. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ali KOC, MD | Contact | 90 312 567 70 00 | 1332 | alikoc.md@gmail.com |
| Munire BABAYIGIT, Assoc. Prof. | Contact | 90 312 567 70 00 | 2031 | munire.babayigit@sbu.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Munire BABAYIGIT, Assoc. Prof. | Ankara Ataturk Sanatorium Research and Training Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Ataturk Sanatorium Research and Training Hospital | Ankara | 06290 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27501016 | Background | 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. | |
| 32439926 | 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. |
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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.
|
| 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. |
|
| 24 hours |
| Additional Analgesia | The time when patients request painkiller for the first time despite their existing analgesia plan. | 24 hours |
| 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. | 24 hours |
| Gas and Stool | Time to pass gas or stool for the first time in the postoperative period. | 24 hours |
| 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. | 24 hours |
| 30801359 | 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. |
| 38811911 | 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. |
| 34626112 | 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. |
| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
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