Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Pain Locoregional Anesthesia Lung Resections Post-operative Complications Post-Operative Pain, Chronic Thoracic Surgery Uniportal Video Assisted Thoracic Surgery (U-VATS)

Keywords

ESPBErectus Spinae Plane BlockSAPBSerratus Anterior Plane BlockICNBIntercostal BlockUniportal VATSThoracic Surgery

Outcome Measures

Primary Outcomes (2)

analgesic drug consumption
number of doses of analgesic drugs administered on patients' request during the postoperative period
first 72 hours after extubation
severity of early postoperative pain
static and dynamic pain scores, measured by the visual analog scale (VAS), at 6 pre-established time-points during the first 48 hours postoperatively.
first 48 hours after extubation

Secondary Outcomes (3)

respiratory and cardiac complications
first 72 hours after extubation

Study Arms (3)

c-ESPB group

Postoperative analgesia ensured by continuous ultrasound-guided ESPB performed at the end of surgery.

Procedure: c-ESPB

c-SAPB group

Postoperative analgesia ensured by continuous SAPB performed by surgeons at the end of surgery.

Procedure: c-SAPB

ICNB-group

Postoperative analgesia ensured by "one-shot" ICNB + continuous intravenous administration of tramadol by elastomeric pump.

Procedure: ICNB

Interventions

c-ESPBProcedure

In the c-ESPB group an ultrasound-guided ESPB will be performed by the attending anaesthesiologist at the end of surgery, immediately after the last surgical stitch and before extubation. After an initial bolus of 20 ml 0,2% ropivacaine, a catheter will be left in place into the fascial plane deep to the erector spinae muscle to ensure continuous infusion (5ml/h for 48 hours) of the local anesthetic.

c-ESPB group

c-SAPBProcedure

In the c-SAPB group SAPB will be performed by surgeons intraoperatively, immediately before the closure of chest wall muscle planes, by injection of 20 ml 0,2% ropivacaine into the fascial plane above the Serratus Anterior muscle. After the initial bolus, a catheter will be left in place into the superficial fascial plane of the Serratus Anterior muscle to ensure continuous infusion (5ml/h for 48 hours) of the local anesthetic.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Adults patients (age \> 18 years) scheduled for Uniportal-VATS lung resections, regardless of whether for benign or malignant disease and for any type of lung resection (segmentectomy, lobectomy, atypical lung resection).

You may qualify if:

Age \>18 years

Sponsors & Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Otherlead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

MeSH Terms

Conditions

Pain, PostoperativeAcute Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

Dania Nachira, MD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
PRINCIPAL INVESTIGATOR
Giovanni Punzo, MD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
PRINCIPAL INVESTIGATOR

Enrollment

75 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 19, 2021

Study Start

January 1, 2022

Actual (reported)

Erector Spinae Plane Block in Uniportal VATS

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (3)

c-ESPB group

c-SAPB group

ICNB-group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (3)

c-ESPB group

c-SAPB group

ICNB-group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations