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This study aims to evaluate whether an ultrasound-guided recto-intercostal fascial plane block performed before surgical incision in patients undergoing laparoscopic cholecystectomy reduces intraoperative opioid and volatile anesthetic consumption. Additionally, the study assesses its effects on postoperative pain and the incidence of nausea and vomiting.
This prospective, randomized controlled trial is conducted at Etlik City Hospital and includes adult patients undergoing elective laparoscopic cholecystectomy. Institutional Ethics Committee approval is obtained, and the study is conducted in accordance with the Declaration of Helsinki.
Participants are randomly assigned into two groups using a closed-envelope method. All patients receive general anesthesia. After induction and intubation, the block group receives an ultrasound-guided recto-intercostal fascial plane block prior to surgical incision, while the control group receives standard analgesic management. Anesthesia is maintained at approximately 1 minimum alveolar concentration (MAC) with bispectral index (BIS) values between 40 and 60.
The primary outcome is intraoperative opioid and volatile anesthetic consumption. Secondary outcomes include intraoperative hemodynamic parameters, postoperative pain intensity assessed using the Numerical Rating Scale (NRS), and the incidence of postoperative nausea and vomiting (PONV).
The recto-intercostal fascial plane block is performed under ultrasound guidance by an experienced anesthesiologist under aseptic conditions. Local anesthetic is administered bilaterally into the fascial plane between the rectus muscle and the costal cartilage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| block group | Active Comparator | block group bilateral 30 mlbupivacaine 0.25% |
|
| control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure: Recto-intercostal fascial plane block | Procedure | A total of 30 mL of 0.25% bupivacaine is administered bilaterally under ultrasound guidance into the recto-intercostal fascial plane prior to surgical incision. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative volatile anesthetic consumption | Total intraoperative volatile anesthetic consumption per patient, measured in milliliters (mL). | During surgery (up to 3 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative opioid consumption | Total amount of opioids administered intraoperatively, measured in micrograms (mcg) per patient. | During surgery (up to 3 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oya Kale, specialist anesthesiology | Contact | +90 0506 408 21 70 | oyakale@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Etlik City Hospital | Recruiting | Ankara | Türkiye | 06170 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41349840 | Background | Rehab OM, Bakr DM, El Malla DA, Helal RAEF, Morsy I, Eloraby M. The analgesic effects of ultrasound-guided recto-intercostal fascial plane block in laparoscopic hiatus hernia repair: A randomized double-blind controlled study. Anaesth Crit Care Pain Med. 2026 May;45(3):101724. doi: 10.1016/j.accpm.2025.101724. Epub 2025 Dec 3. | |
| 37295124 |
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Individual participant data (IPD) will not be shared. All data will be de-identified to protect participant confidentiality and will be accessible only to the study investigators.
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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The block procedure is performed after induction of general anesthesia, and participants are unaware of group allocation. Postoperative outcome assessment is conducted by an investigator who is blinded to group assignment.
| Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |