Comparing Erector Spinae Plane (ESP) and Thoracic Paravertebral (TPV) Block Analgesic Effect After Elective VATS
- Conditions
- ThoracicSurgery
- Interventions
- Procedure: ESP block
- Registration Number
- NCT05798585
- Lead Sponsor
- Andrea Saporito
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- patients over 18 year of age undergoing elective VATS lung resection at ORBV
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description US-guided ESP block + sham US-guided TPV block 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 ESP block ESP block will be performed with physiological solution under US guide; instead TPV block with local anesthetic
- Primary Outcome Measures
Name Time Method cumulative dose of opioids at 24 and 48 h 48 hours by using a PCA we will see how many times the patient asked for analgesia
- Secondary Outcome Measures
Name Time Method Episodes of urinary retention 48 hours We will observe if any episode of urinary retention is present
Pain scores at 4h, 8h, 24h, 48h via numeric rating scale (NRS) at rest and during cough 48 hours we will test pain score in several moment by asking the NRS scale at rest and during cough
Hypotension 48 hours we will compare the systolic pressure before anesthesia and after the block have been performed
Procedure time and complications 48 hours we will observe the time necessary to perform the block and the complications after it
Need for anti-nausea medication (dosage, doses and time points) 48 hours We will observe if the patient need any type of anti-nausea medication
Episodes of vomiting 48 hours We will observe if any episode of vomiting is present
Length of hospital stay 48 hours We will observe how long the hospital stay is
Cardio-pulmonary complications 48 hours we will check if any cardio-pulmonary complication is present after surgery during the hospital stay
Need for epidural catheter 48 hours We will observe if the patient needs for an epidural catheter
Trial Locations
- Locations (1)
Ente Ospedaliero Cantonale, Bellinzona
🇨ðŸ‡Bellinzona, Switzerland