Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Laparoscopic Cholecystectomy

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-02-01

Brief Summary

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The study is planned as a single-center prospective randomized study and includes patients undergoing laparoscopic cholecystectomy. The aim of this study is to compare postoperative analgesic efficacy of erector spinae plane block and thoracic paravertebral block. Primary outcome is 24-hour postoperative opioid consumption.

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Detailed Description

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All patients in the operating room receive the same anesthetic management under standard monitoring modalities. Both erector spinae plane block (ESPB) and thoracic paravertebral block (TPVB) are performed under ultrasound guidance at the T8 level using a linear probe and a longitudinal out-of-plane technique before induction of anesthesia. For ESPB, 10 mL of 0.375% bupivacaine is injected bilaterally between the deep fascia of the erector spinae muscle and the transverse process. For TPVB, 10 mL of 0.375% bupivacaine is injected bilaterally into the paravertebral space. After standard anesthesia induction, anesthesia is maintained with inhalation agents. Four milligrams of dexamethasone and 8 mg of ondansetron are administered for postoperative nausea and vomiting prophylaxis. As part of multimodal analgesia, all patients receive 1 g of paracetamol and 20 mg of tenoxicam.

All patients are followed according to a standardized postoperative analgesia protocol, which includes tramadol patient-controlled analgesia (10 mg bolus, 20-minute lockout). Postoperative static and dynamic pain scores are evaluated using the numeric rating scale (NRS) at 0, 1, 4, 6, 12, 18, and 24 hours. If the NRS score is greater than 3, 0.5 mg/kg meperidine is administered as rescue analgesia.

Conditions

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Pain, Acute Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Group 1: ESPB

Erector spinal plane block

Group Type EXPERIMENTAL

ESPB

Intervention Type PROCEDURE

10 mL of 0.375% bupivacaine is injected on each side between the deep fascia of the erector spinae muscle and the transverse process. Additionally, tramadol is administered via intravenous patient-controlled analgesia.

Group 2: TPVB

Thoracic paravertebral block

Group Type EXPERIMENTAL

TPVB

Intervention Type PROCEDURE

10 mL of 0.375% bupivacaine is injected on each side between the superior costotransverse ligament and the pleura.

Group 3: IV

intravenous analgesia

Group Type EXPERIMENTAL

IV

Intervention Type PROCEDURE

Tramadol is administered via intravenous patient-controlled analgesia.

Interventions

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ESPB

10 mL of 0.375% bupivacaine is injected on each side between the deep fascia of the erector spinae muscle and the transverse process. Additionally, tramadol is administered via intravenous patient-controlled analgesia.

Intervention Type PROCEDURE

TPVB

10 mL of 0.375% bupivacaine is injected on each side between the superior costotransverse ligament and the pleura.

Intervention Type PROCEDURE

IV

Tramadol is administered via intravenous patient-controlled analgesia.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Elective cholecystectomy
* Age \>18years
* American Society of Anesthesiologists classification I-III

Exclusion Criteria

* Presence of contraindications for using regional anesthesia ( not having patient approval, bleeding diathesis or use of anticoagulants, infection at the injection site, and allergy to local anesthetics)
* Chronic analgesic use
* Open cholecystectomy or conversion to open cholecystectomy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No