Comparing Erector Spinae Plane (ESP) and Thoracic Paravertebral (TPV) Block Analgesic Effect After Elective Video Assisted Thoracic Surgery (VATS): a Single Center, Randomized, Multiple-blinded, Controlled, Non Inferiority Trial
| Registry | NCT05798585 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, parallel, masking: single, treatment |
| Enrollment | 50 (Actual) |
| Sponsor | Andrea Saporito (Other) |
| Conditions | Surgery, Thoracic |
| Interventions | ESP block (Procedure) |
| Dates | start 2023-03-31, primary completion 2024-12-31, completion 2024-12-31, first posted 2023-04-04, last updated 2025-02-28 |
| Locations | 1 site in Switzerland |
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The aim of the study is to compare two different locoregional techniques in VATS.
There are clear clinical and logistic reasons for pursuing the best possible post-operative pain management avoiding the negative side effects of opioid treatment; in order to garantee an enhanced recovery after surgery. A short hospital stay is fundamental to reduce patient morbidity and costs. Regional anesthetic nerve blocks are an ideal option to achieve this goal.
Paravertebral block serves as an ideal approach for thoracic and abdominal surgery through delivering segmental anesthesia of operative sites. Thoracic paravertebral block has superior analgesia as well as fewer complications than systemic opioids. It has been successfully applied in sternotomy, breast surgery, abdominoplasty, and laparoscopic cholecystectomy. ESP block is a recently described technique, with promising results in different scenarios. It probabily has a better risk profile than PVB, for its lower possibility of accidental pleural puncture and reabsorption of local anesthtetic than PVB one
| Arm | Type | Interventions | Description |
|---|---|---|---|
| US-guided ESP block + sham US-guided TPV block | Experimental | Procedure: ESP block | ESP block will be performed with local anesthetic under US guide; instead TPV block with physiological solution |
| sham US-guided ESP block + US-guided TPV block | Sham comparator | Procedure: ESP block | ESP block will be performed with physiological solution under US guide; instead TPV block with local anesthetic |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * patients over 18 year of age undergoing elective VATS lung resection at ORBV Exclusion Criteria: * patients with inability to consent, contraindications to standard care, or factors that can cause bias in interpretation, absolute contraindications to the regional anesthesia techniques studied (patient's refusal, allergy to local anesthetics, infections in the site of injection). Pregnant women are not a target study-group so they are excluded for design simplification. Conversion to the open technique will be a post-randomization exclusion factor concerning the main outcomes
| Facility | City | Country | Status |
|---|---|---|---|
| Ente Ospedaliero Cantonale, Bellinzona | Bellinzona, Bellinzona | Switzerland |