Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Laparoscopic Cholecystectomy

Not Applicable

Not yet recruiting

• Conditions: Pain, Acute Postoperative

• Registration Number: NCT07149584
• Lead Sponsor: Istanbul University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-23
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study Start: 2025-09-01
• Study First Posted: 2025-09-02
• Last Update Posted: 2025-09-02
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tramadol consumption	postoperative 24 hours	amount of postoperative 24-hour tramadol consumption

Secondary Outcome Measures

Name	Time	Method
Amount of fentanyl	during surgery	Amount of fentanyl used intraoperatively
Static and dynamic pain score	postoperative 24 hours	Static and dynamic pain scores are assessed with numeric rating scale at 0., 1., 4., 6., 12., 18. and 24. hours.
First rescue analgesic time	postoperative 24 hours	The first time patient required rescue analgesic.
Number of patients required rescue analgesic.	postoperative 24 hours	If the NRS score is greater than 3, 0.5 mg/kg meperidine is administered as rescue analgesia.
Nausea and vomiting	postoperative 24 hours	Number of patients experienced postoperative nausea and vomiting
Complications	postoperative 24 hours	Number of patients experienced complications postoperatively
Quality of recovery	postoperative 24 hours	Patient recovery quality is evaluated using the Quality of Recovery-15 (QoR-15) questionnaire. QoR-15 scores range from 0 (extremely poor quality of recovery) to 150 (excellent quality of recovery).
Length of hospital stay	up to 1 week	Length of hospital stay

Trial Locations

Locations (1)

Istanbul University, Istanbul Faculty of Medicine; Istanbul, Turkey (Türkiye)