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Analgesic Non Inferiority of the Thoracic Bi-block in Comparison With Thoracic Epidural for VATS.

Analgesic Non Inferiority of the Thoracic Bi-block Combining an Erector Spinae Muscle Plane Block and a Serratus Anterior Muscle Plane Block in Comparison With Thoracic Epidural for Video-Assisted Thoracic Surgery.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04538235
Acronym
ANESSTEVATS
Enrollment
90
Registered
2020-09-04
Start date
2019-10-20
Completion date
2019-12-31
Last updated
2020-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Enhanced Recovery After Surgery, Erector Spinae Muscle Plane Block, Lung Cancer, Pleural Diseases, Serratus Anterior Muscle Plane Block, Thoracic Epidural, Video-Assisted Thoracic Surgery

Keywords

regional anesthesia, video-assisted thoracic surgery

Brief summary

Video-Assisted thoracic surgery (VATS) is the standard treatment for localized lung cancer. However, there is no consensus on analgesic management in patients undergoing VATS. The aim of the study is to compare the analgesic efficacy of thoracic epidural with that a Bi-block combining an Erector Spinae muscle plane Block (ESP) and a Serratus Anterior Block (SAP) in patients undergoing VATS for lung or pleural surgery. Our main hypothesis is that the analgesic efficacy of the Bi-block, assessed by morphine consumption, is not inferior to that provided by a thoracic epidural during the first 48 hours after VATS. We conducted a age, gender and type of surgery-matched retrospective cohort study in the Department of Thoracic Anesthesia of the Montpellier University Hospital (France).

Interventions

PROCEDUREThoracic Regional Analgesia

In the TEA group, a thoracic epidural was performed before VATS. In the Bi-block group, a SAP block associated with an ESP block were performed before surgical incision under general anesthesia.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* To be over 18. * To be scheduled for VATS in the center of the study during the study period. * Thoracic Epidural analgesia of Bi-block analgesia.

Exclusion criteria

* Chronic pain or opioid use before surgery (6 months). * Postoperative hospitalization in ICU during the first two days. * Postoperative surgical complication needing surgical revision during the first two days. * Preoperative dementia or other psychiatric disease incompatible with VAS pain scoring.

Design outcomes

Primary

MeasureTime frameDescription
cumulative morphine consumption on postoperative day 2postoperative day 2cumulative morphine consumption on postoperative day 2, including the morphine administered in Post anesthesia care unit (PACU), on postoperative day 0, 1 and 2.

Secondary

MeasureTime frameDescription
Pain assessed by visual analog pain scale (VAS)up to postoperative day 2mean VAS, maximal VAS, number of events with a VAS \> 3
Urinary retentionup to postoperative day 2
hypotensionup to postoperative day 2
non-opioid analgesics consumption on postoperative day 2postoperative day 2Paracetamol, Tramadol, Ketoprofen, Nefopam cumulative consumption on POD 2.
duration of hospitalizationup to postoperative day 2
occurrence of pruritup to postoperative day 2
pleural drain durationup to postoperative day 2

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026