Trials / Completed
CompletedNCT07149584
Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Laparoscopic Cholecystectomy
Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Laparoscopic Cholecystectomy: A Randomized Controlled Trial on Opioid Consumption
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Istanbul University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 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. |
| PROCEDURE | TPVB | 10 mL of 0.375% bupivacaine is injected on each side between the superior costotransverse ligament and the pleura. |
| PROCEDURE | IV | Tramadol is administered via intravenous patient-controlled analgesia. |
Timeline
- Start date
- 2025-09-01
- Primary completion
- 2026-02-23
- Completion
- 2026-02-23
- First posted
- 2025-09-02
- Last updated
- 2026-03-02
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07149584. Inclusion in this directory is not an endorsement.