External Oblique Intercostal Block in Laparoscopic Cholecystectomy
NCT ID: NCT07164664
Last Updated: 2025-12-23
Study Results
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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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-09-10
2026-01-01
Brief Summary
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Detailed Description
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Regional anesthesia techniques, particularly abdominal wall and fascial plane blocks, have gained increasing attention as part of multimodal analgesia strategies aimed at reducing opioid consumption and minimizing related adverse effects. Among these, the external oblique intercostal block (EOIB) has recently been described as a novel regional technique that may provide effective postoperative pain relief.
In clinical practice, port-site infiltration with local anesthetics is a commonly used and simple technique for providing postoperative analgesia in laparoscopic procedures, although its effectiveness may be limited.
The present study was designed to compare the effectiveness of the external oblique intercostal block with port-site infiltration in patients undergoing laparoscopic cholecystectomy, with a focus on postoperative pain scores and opioid consumption during the first 24 hours after surgery.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group EOIB
A bilateral External Oblique Intercostal Block (30 ml, %0.25 bupivacaine, bilaterally) + IV morphine patient-controlled analgesia (PCA)
External Oblique Intercostal Block
Bilateral ultrasound-guided External Oblique Intercostal Block (30 mL, 0.25% bupivacaine, bilaterally) will be performed. All patients will receive multimodal analgesia, including a single dose of IV tenoxicam 20 mg. Additionally, 15 mg/kg IV paracetamol (based on IBW) will be administered at skin closure and continued every 6 hours postoperatively. A standardized IV PCA protocol will be initiated using a PCA device programmed to deliver morphine boluses of 0.01-0.015 mg/kg (IBW), with a 6-minute lockout and a 4-hour maximum of 0.1-0.15 mg/kg (IBW). Upon arrival in the PACU, patients with a resting NRS ≥4 will receive titrated IV morphine boluses of 0.03 mg/kg (IBW; max 10 mg) every 10 minutes until pain is controlled. In the surgical ward, patients with breakthrough pain (NRS ≥4) despite PCA use will receive IV tramadol 1-1.5 mg/kg (IBW) in 50-100 mg slow doses, not exceeding 400 mg/day.All patients will receive 8 mg dexamethasone and 0.15 mg/kg ondansetron (IBW) for PONV prophylaxis.
ıv morphine PCA
A standardized IV PCA protocol will be initiated for all patients using a PCA device (Body Guard 575 pain manager, UK), programmed to deliver morphine boluses of 0.01-0.015 mg/kg (IBW), with a 6-minute lockout and a 4-hour maximum dose of 0.1-0.15 mg/ kg (IBW). No basal infusion will be used.
Group PSI
Port sites injection (5 mL at each port site, 0.25% bupivacaine solution ) + IV morphine patient-controlled analgesia (PCA)
Port-Site Infiltration
Before port placement, 0.25% bupivacaine solution will be injected into the laparoscopic port insertion sites (5 mL at each port site).
ıv morphine PCA
A standardized IV PCA protocol will be initiated for all patients using a PCA device (Body Guard 575 pain manager, UK), programmed to deliver morphine boluses of 0.01-0.015 mg/kg (IBW), with a 6-minute lockout and a 4-hour maximum dose of 0.1-0.15 mg/ kg (IBW). No basal infusion will be used.
Interventions
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External Oblique Intercostal Block
Bilateral ultrasound-guided External Oblique Intercostal Block (30 mL, 0.25% bupivacaine, bilaterally) will be performed. All patients will receive multimodal analgesia, including a single dose of IV tenoxicam 20 mg. Additionally, 15 mg/kg IV paracetamol (based on IBW) will be administered at skin closure and continued every 6 hours postoperatively. A standardized IV PCA protocol will be initiated using a PCA device programmed to deliver morphine boluses of 0.01-0.015 mg/kg (IBW), with a 6-minute lockout and a 4-hour maximum of 0.1-0.15 mg/kg (IBW). Upon arrival in the PACU, patients with a resting NRS ≥4 will receive titrated IV morphine boluses of 0.03 mg/kg (IBW; max 10 mg) every 10 minutes until pain is controlled. In the surgical ward, patients with breakthrough pain (NRS ≥4) despite PCA use will receive IV tramadol 1-1.5 mg/kg (IBW) in 50-100 mg slow doses, not exceeding 400 mg/day.All patients will receive 8 mg dexamethasone and 0.15 mg/kg ondansetron (IBW) for PONV prophylaxis.
Port-Site Infiltration
Before port placement, 0.25% bupivacaine solution will be injected into the laparoscopic port insertion sites (5 mL at each port site).
ıv morphine PCA
A standardized IV PCA protocol will be initiated for all patients using a PCA device (Body Guard 575 pain manager, UK), programmed to deliver morphine boluses of 0.01-0.015 mg/kg (IBW), with a 6-minute lockout and a 4-hour maximum dose of 0.1-0.15 mg/ kg (IBW). No basal infusion will be used.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA)classification II-III patients.
* Patients who can use PCA.
* Patients who will sign the informed consent form.
Exclusion Criteria
* They will have a body mass index (BMI) greater than 35 kg/m2.
* They will have contraindications to peripheral nerve blocks (e.g., coagulopathy, abnormal INR, thrombocytopenia, local or systemic infection).
* They will have clinically significant cardiovascular or cerebrovascular disease.
* They will have severe hepatic, renal, or respiratory dysfunction. They will have known drug allergies.
* They will have a history of substance abuse.
* They will have chronic opioid use, defined as regular use of ≥15 mg oral morphine equivalent per day for at least 30 consecutive days within the past 3 months.
* They will have chronic pain syndromes (e.g., fibromyalgia, diabetic neuropathy, or chronic low back pain).
* They will have neuropsychiatric disorders or cognitive impairment that precludes effective communication with the investigators.
18 Years
75 Years
ALL
Yes
Sponsors
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Ondokuz Mayıs University
OTHER
Responsible Party
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Esra Turunc
Director
Principal Investigators
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Esra Turunc
Role: STUDY_DIRECTOR
Ondokuz Mayis University, School of Medicine, Department of Anesthesiology
Locations
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Ondokuz Mayis University
Samsun, , Turkey (Türkiye)
Countries
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Central Contacts
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Esra Turunc
Role: CONTACT
Facility Contacts
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Esra Turunc, MD
Role: primary
Other Identifiers
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EOIBLIALC2025
Identifier Type: -
Identifier Source: org_study_id