Clinical trial NCT04303585: SAP Versus ESP Block in Multimodal Pain Management in Mini-invasive Thoracic Surgery: an Observational Prospective Multicentric Study
Official title: Blocco Del Dentato Anteriore e Blocco Del Muscolo Erettore Della Colonna Vertebrale Nella Gestione Multimodale Del Dolore in Chirurgia Toracica Mininvasiva: Studio Osservazionale Prospettico Multicentrico
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SAP Block Versus ESP Block
Pain, Postoperative
Evaluation of Locoregional Techniques
Multimodal Pain Management
Keywords: SAP block
ESP block
Pain management
Mini-invasive
Thoracic surgery
SAP
ESP
Locoregional
Multimodal
Lead sponsor: University of Trieste
Sponsor class: OTHER
Collaborators: name: Cliniche Humanitas Gavazzeni
name: A.O.U. Città della Salute e della Scienza - Molinette Hospital
First posted: 2020-03-11
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are hospitalized in one of the centers taking part in the study undergoing mini-invasive lung-resective thoracic surgery.

Brief summary: Thoracic surgery is characterized by acute perioperative pain. There are different ways to provide analgesia, such as intravenous analgesics (opioids or non-opioids) or loco-regional procedures; these techniques are often used together in the context of a multimodal approach to pain management, in order to exploit their synergistic action and minimize side effects. In this observational prospective multicentric study the investigators evaluate the effectiveness of two routinely administered ultrasound guided loco-regional analgesic techniques in providing analgesia to patients undergoing mini-invasive lung-resective thoracic surgery. The two techniques compared are the serratus anterior plane (SAP) block and the erector spinae plane (ESP) block.

Detailed description: Whatever the loco-regional technique is (SAP block or ESP block), it must have been administered in the immediate preoperative phase; both procedures are routinely used for analgesic purpose in the clinical practice of the three centers involved in the study and are performed under ultrasound guide. Using medical records, data collected by Acute Pain Service nurses and patients' interviews useful data will be collected: demographic and clinical characteristics (age, sex, weight, comorbidities), surgical data (type of procedure, surgical approach and duration of surgery) and anesthesia data (type of block, dose and type of local anesthetic with record of potential side effects), intraoperative and postoperative opioid and non-opioid analgesic consumption (and rescue if needed) with record of potential side effects, pain evaluation in the first 24 hours after surgery and after at 3 months.

Eligibility criteria: Inclusion Criteria:

* Lung-resective thoracic surgery (lobectomy, bilobectomy, segmentectomy and wedge resection) with videothoracoscopic or mini-thoracotomic approach (maximum duration 180 minutes)
* BMI ranging from 18 to 30
* Age \> 18 years
* ASA I-III
* Ultrasound guided preoperative ESP block or SAP block
* Remifentanil as intraoperative opioid

Exclusion Criteria:

* Patient's refusal
* Weight \< 50 kg
* Pregnancy
* Emergent surgery
* Chronic opioid therapy
* History of drug or benzodiazepine addiction or alcohol abuse
* Previous thoracic surgery

Primary outcomes:
measure: Morphine consumption
timeFrame: First 24 hours after surgery
Secondary outcomes:
measure: Intraoperative opioid consumption
timeFrame: Duration of surgical procedure
measure: Numeric Rating Scale (NRS)
timeFrame: First 24 hours after surgery, then after 3 months
measure: Analgesic rescue and corticosteroids
timeFrame: First 24 hours after surgery
measure: Side effects
timeFrame: First 24 hours after surgery
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Cliniche Humanitas Gavazzeni
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza - Molinette Hospital
city: Trieste
country: Italy
facility: Cattinara Hospital
Study officials:
affiliation: University of Trieste
name: Umberto Lucangelo, MD PhD
role: STUDY_CHAIR
affiliation: University of Trieste
name: Marzia Umari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniche Humanitas Gavazzeni
name: Giovanni Albano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: A.O.U. Città della Salute e della Scienza - Molinette Hospital
name: Edoardo Ceraolo, MD
role: PRINCIPAL_INVESTIGATOR
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