External Oblique Intercostal Block in Laparoscopic Cholecystectomy

NCT07164664 | Completed

• 1 other identifier: EOIBLIALC2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Adequate postoperative pain management is essential for improving patient comfort and recovery after laparoscopic cholecystectomy. This study evaluated the effectiveness of the external oblique intercostal block compared with port-site infiltration in terms of pain scores and opioid consumption during the first 24 hours after surgery.

Conditions

Pain, Postoperative; Pain, Acute; Opioid Use

Keywords

Postoperative pain; regional anesthesia; external oblique intercostal block

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid consumption in the first 24 hours after surgery

  The primary outcome will be defined as cumulative opioid consumption during the first 24 hours following surgery, which will be calculated in intravenous morphine milligram equivalents (IV-MME), encompassing both PCA- administered morphine and rescue intravenous tramadol, according to the standardized ESAIC conversion guidelines. Patients can request opioids via a PCA device when their NRS score is≥ 4.

  Postoperative day 1

Secondary Outcomes (7)

• Cumulative opioid consumption in the first 12 hours after surgery

  Postoperative 12 hours

• Intraoperative Remifentanil Consumption

  The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes

• Numerical Rating Scale Assessment of Postoperative Pain

  Postoperative day 1

• Time to First Opioid Demand via PCA

  Postoperative day 1

• The number of patients who required rescue analgesia.

  Postoperative day 1

Study Arms (2)

Group EOIB

ACTIVE COMPARATOR

A bilateral External Oblique Intercostal Block (30 ml, %0.25 bupivacaine, bilaterally) + IV morphine patient-controlled analgesia (PCA)

Procedure: External Oblique Intercostal Block; Drug: ıv morphine PCA

Group PSI

ACTIVE COMPARATOR

Port sites injection (5 mL at each port site, 0.25% bupivacaine solution ) + IV morphine patient-controlled analgesia (PCA)

Procedure: Port-Site Infiltration; Drug: ıv morphine PCA

Interventions

External Oblique Intercostal Block PROCEDURE

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.

Also known as: EOIB

Group EOIB

ıv morphine PCA DRUG

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.

Also known as: PCA

Group EOIB; Group PSI

Port-Site Infiltration PROCEDURE

Before port placement, 0.25% bupivacaine solution will be injected into the laparoscopic port insertion sites (5 mL at each port site).

Also known as: PSI

Group PSI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-75 undergoing elective Laparoscopic Cholecystectomy
• American Society of Anesthesiologists (ASA)classification I-III patients.
• Patients who can use PCA.
• Patients who will sign the informed consent form.

You may not qualify if:

• They will refuse to participate.
• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, 55139, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Interventions

Passive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena

Study Officials

• Esra Turunc

  Ondokuz Mayis University, School of Medicine, Department of Anesthesiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based "Research Randomizer" (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1 ratio. A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist administering the block/blocks about which group the patient is in immediately before administration. Researchers, surgeons, and nurses will not be aware of the randomization of groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous, 2013)'.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: September 10, 2025
• Primary Completion: January 10, 2026
• Study Completion: February 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

TU (1)