Regional Analgesia Techniques for Laparoscopic Cholecystectomy (PVB-EOI-PCA)

Çukurova University

Status: Not yet enrolling

Conditions: Postoperative Pain; External Oblique Intercostal Plane Block; Laparoscopic Cholecystectomy; Paravertebral Block; Patient Controlled Analgesia

Treatments: Drug: Tramadol IV Patient-Controlled Analgesia (PCA); Procedure: External Oblique Intercostal Block (EOI Block); Procedure: Paravertebral Block (PVB)

Study type: Interventional

Funder types: Other

Identifiers

NCT07241949

Pending-EC-2025-NSadikoglu

Details and patient eligibility

About

This single-center, prospective, randomized controlled trial aims to compare the effects of paravertebral block (PVB), external oblique intercostal (EOI) block, and intravenous patient-controlled analgesia (PCA) with tramadol on postoperative pain and opioid consumption in patients undergoing elective laparoscopic cholecystectomy. The primary endpoint is total tramadol consumption within 24 hours postoperatively. Secondary outcomes include pain scores, additional analgesic use, incidence of nausea/vomiting, mobilization time, and length of hospital stay.

Full description

This single-center, prospective, randomized controlled clinical trial aims to compare the analgesic efficacy and opioid-sparing effects of paravertebral block (PVB), external oblique intercostal (EOI) block, and intravenous patient-controlled analgesia (IV PCA) in adult patients undergoing elective laparoscopic cholecystectomy (LC) under general anesthesia.

Although laparoscopic cholecystectomy is a minimally invasive procedure, postoperative pain remains a significant clinical problem, particularly during the first 24 hours after surgery. Effective multimodal analgesia is essential to improve patient comfort, facilitate early mobilization, and reduce opioid-related side effects. Regional anesthesia techniques, such as PVB and EOI block, target both somatic and visceral components of pain and may offer superior postoperative analgesia compared with systemic opioid administration alone.

After obtaining informed consent, eligible patients (aged 18-65 years, ASA I-III) scheduled for elective LC will be randomly assigned to one of three groups using the sealed envelope method:

Group P (Paravertebral Block): After induction of general anesthesia, bilateral paravertebral blocks will be performed at thoracic levels with 0.25% bupivacaine (20 mL per side; total 40 mL).

Group E (External Oblique Intercostal Block): After induction, bilateral EOI blocks will be performed using 0.25% bupivacaine (20 mL per side; total 40 mL) injected into the fascial plane between the external oblique and intercostal muscles under ultrasound guidance.

Group C (Control): Patients will receive standard general anesthesia followed by IV PCA with tramadol (maximum dose 400 mg/24h) and IV paracetamol 1 g every 8 hours.

All patients will receive standard intraoperative monitoring and anesthesia management. Postoperative analgesia will be evaluated using an 11-point Numerical Rating Scale (NRS, 0-10) both at rest and during movement at 20 minutes, 6 hpurs, 12 hours, and 24 hours after surgery. If the NRS score is ≥4 in the postoperative care unit, IV morphine (0.05 mg/kg), If the NRS score is ≥7 Meperidine 0.3 mg/kg will be administered as rescue analgesia.

The primary outcome is total tramadol consumption within the first 24 postoperative hours.

Secondary outcomes include pain scores at predefined time points, requirement for rescue analgesics, incidence of postoperative nausea and vomiting (PONV), time to mobilization, and length of hospital stay.

Patients will be followed for 24 hours postoperatively. The anesthesia team performing the blocks will not participate in data collection. Pain assessments will be conducted by an investigator blinded to group allocation to minimize bias.

This study will provide comparative data on two ultrasound-guided regional anesthesia techniques and systemic opioid-based analgesia for LC, aiming to identify the method that ensures optimal postoperative pain control with the least opioid requirement and side effects.

Enrollment: 147 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 65 years
• Scheduled for elective laparoscopic cholecystectomy under general anesthesia
• ASA physical status I-III
• Able to understand the study procedure and provide informed consent

Exclusion criteria

Patient refusal or inability to provide informed consent

Allergy or contraindication to local anesthetics, tramadol, or study medications

Coagulopathy or current anticoagulant therapy

Local infection at the planned block injection site

Severe hepatic or renal impairment

Chronic opioid use or opioid dependence

Neurological or psychiatric disorders affecting pain perception or communication

Pregnancy or breastfeeding

Body mass index (BMI) > 35 kg/m²

Conversion to open cholecystectomy during surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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147 participants in 3 patient groups

Paravertebral Block Group

Active Comparator group

Description:

Participants in this arm will receive bilateral paravertebral block after induction of general anesthesia. Under ultrasound guidance, 0.25% bupivacaine (20 mL per side; total 40 mL) will be administered to provide postoperative analgesia following laparoscopic cholecystectomy. Patients will also receive standard intravenous paracetamol postoperatively.

Treatment:

Procedure: Paravertebral Block (PVB)

External Oblique Intercostal Block Group

Active Comparator group

Description:

Participants in this arm will receive bilateral external oblique intercostal (EOI) block after induction of general anesthesia. Under ultrasound guidance, 0.25% bupivacaine (20 mL per side; total 40 mL) will be injected into the fascial plane between the external oblique and intercostal muscles. Standard intravenous paracetamol will be administered postoperatively.

Treatment:

Procedure: External Oblique Intercostal Block (EOI Block)

Control Group - IV PCA Tramadol

Active Comparator group

Description:

Participants in this arm will receive intravenous patient-controlled analgesia (PCA) with tramadol for postoperative pain management. The PCA pump will be set to a maximum dose of 400 mg tramadol in 24 hours. Standard intravenous paracetamol (1 g every 8 hours) will also be administered. No regional anesthesia block will be performed in this group.

Treatment:

Drug: Tramadol IV Patient-Controlled Analgesia (PCA)