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

July 1, 2020 updated by: Marzia Umari, University of Trieste

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bergamo, Italy, 24125
        • Recruiting
        • Cliniche Humanitas Gavazzeni
        • Contact:
        • Principal Investigator:
          • Giovanni Albano, MD
        • Sub-Investigator:
          • Claudio Roscitano, MD
        • Sub-Investigator:
          • Costantino Solinas, MD
      • Torino, Italy, 10126
        • Recruiting
        • A.O.U. Città della Salute e della Scienza - Molinette Hospital
        • Principal Investigator:
          • Edoardo Ceraolo, MD
        • Contact:
        • Sub-Investigator:
          • Giulio Rosboch, MD
        • Sub-Investigator:
          • Eva Pii, Resident
        • Sub-Investigator:
          • Federica Giunta, Resident
        • Sub-Investigator:
          • Giulio Padovani, Resident
      • Trieste, Italy, 34149
        • Recruiting
        • Cattinara Hospital
        • Contact:
        • Principal Investigator:
          • Marzia Umari, MD
        • Sub-Investigator:
          • Valentina Carpanese, Resident
        • Sub-Investigator:
          • Valeria Moro, Resident
        • Sub-Investigator:
          • Matteo Stella, Resident
        • Sub-Investigator:
          • Giacomo Paluzzano, Resident
        • Sub-Investigator:
          • Edoardo Moro, Resident
        • Sub-Investigator:
          • Lucia Comuzzi, MD
        • Sub-Investigator:
          • Giulia Colussi, Resident
        • Sub-Investigator:
          • Giovanna Gallas, Resident
        • Sub-Investigator:
          • Caterina Peratoner, Resident
        • Sub-Investigator:
          • Sara Rigutti, Resident
        • Sub-Investigator:
          • Enrico Lena, MD
        • Sub-Investigator:
          • Gaia Maria Baldo, Resident

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SAP block
This group includes patients who receive preoperative Serratus Anterior Plane block
Procedure: SAP block
The anesthesiologist performs SAP block immediately before surgery under ultrasound guide
ESP block
This group includes patients who receive preoperative Erector Spinae Plane block
Procedure: ESP block
The anesthesiologist performs ESP block immediately before surgery under ultrasound guide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: First 24 hours after surgery
Evaluation of morphine consumption in the first 24 hours after surgery
First 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative opioid consumption
Time Frame: Duration of surgical procedure
Evaluation of opioid consumption during lung-resective thoracic surgery
Duration of surgical procedure
Numeric Rating Scale (NRS)
Time Frame: First 24 hours after surgery, then after 3 months
Evaluation of NRS for static, dynamic and cough-associated pain
First 24 hours after surgery, then after 3 months
Analgesic rescue and corticosteroids
Time Frame: First 24 hours after surgery
Evaluation of eventual administration of rescue analgesic drugs and corticosteroids in the first 24 hours after surgery
First 24 hours after surgery
Side effects
Time Frame: 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
First 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Trieste

Collaborators

Cliniche Humanitas Gavazzeni
A.O.U. Città della Salute e della Scienza - Molinette Hospital

Investigators

  • Study Chair: Umberto Lucangelo, MD PhD, University of Trieste
  • Principal Investigator: Giovanni Albano, MD, Cliniche Humanitas Gavazzeni
  • Principal Investigator: Edoardo Ceraolo, MD, A.O.U. Città della Salute e della Scienza - Molinette Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2019

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

March 8, 2020

First Submitted That Met QC Criteria

March 8, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

July 2, 2020

Last Update Submitted That Met QC Criteria

July 1, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 145_2018 Blocco gran dentato

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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