SAP Versus ESP Block in Multimodal Pain Management in Mini-invasive Thoracic Surgery: an Observational Prospective Multicentric Study

• Conditions: Multimodal Pain Management; Evaluation of Locoregional Techniques; SAP Block Versus ESP Block; Pain, Postoperative
• Interventions: Procedure: SAP block; Procedure: ESP block

• Registration Number: NCT04303585
• Lead Sponsor: University of Trieste

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.

Study Timeline

• Study Start: 2019-06-27
• Study First Submitted: 2020-03-08
• Study First Submitted QC: 2020-03-08
• Study First Posted: 2020-03-11
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-02
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SAP block	SAP block	This group includes patients who receive preoperative Serratus Anterior Plane block
ESP block	ESP block	This group includes patients who receive preoperative Erector Spinae Plane block

Primary Outcome Measures

Name	Time	Method
Morphine consumption	First 24 hours after surgery	Evaluation of morphine consumption in the first 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Intraoperative opioid consumption	Duration of surgical procedure	Evaluation of opioid consumption during lung-resective thoracic surgery
Numeric Rating Scale (NRS)	First 24 hours after surgery, then after 3 months	Evaluation of NRS for static, dynamic and cough-associated pain
Analgesic rescue and corticosteroids	First 24 hours after surgery	Evaluation of eventual administration of rescue analgesic drugs and corticosteroids in the first 24 hours after surgery
Side effects	First 24 hours after surgery	Evaluation of eventual side effects related to the locoregional techinque or the analgesics used (LAST, hypotension, Post Operative Nausea and Vomiting (PONV) and opioid-related side effects) in the first 24 hours after surgery

Trial Locations

Locations (3)

Cliniche Humanitas Gavazzeni; 🇮🇹 Bergamo, Italy

A.O.U. Città della Salute e della Scienza - Molinette Hospital; 🇮🇹 Torino, Italy

Cattinara Hospital; 🇮🇹 Trieste, Italy