Clinical trial NCT05798585: Comparing Erector Spinae Plane (ESP) and Thoracic Paravertebral (TPV) Block Analgesic Effect After Elective VATS
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Thoracic
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare two different locoregional techniques in VATS.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: cumulative dose of opioids at 24 and 48 h
timeFrame: 48 hours
Secondary outcomes:
measure: Pain scores at 4h, 8h, 24h, 48h via numeric rating scale (NRS) at rest and during cough
timeFrame: 48 hours
measure: Hypotension
timeFrame: 48 hours
measure: Cardio-pulmonary complications
timeFrame: 48 hours
measure: Procedure time and complications
timeFrame: 48 hours
measure: Need for anti-nausea medication (dosage, doses and time points)
timeFrame: 48 hours
measure: Episodes of vomiting
timeFrame: 48 hours
measure: Episodes of urinary retention
timeFrame: 48 hours
measure: Length of hospital stay
timeFrame: 48 hours
measure: Need for epidural catheter
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Ente Ospedaliero Cantonale, Bellinzona
Study officials:
affiliation: Ente Ospedaliero Cantonale, Bellinzona
name: Andrea Saporito, Anesth
role: STUDY_CHAIR
References: