Clinical trial NCT04538235: Analgesic Non Inferiority of the Thoracic Bi-block in Comparison With Thoracic Epidural for VATS.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erector Spinae Muscle Plane Block
Serratus Anterior Muscle Plane Block
Video-Assisted Thoracic Surgery
Lung Cancer
Pleural Diseases
Thoracic Epidural
Analgesia
Enhanced Recovery After Surgery
Keywords: regional anesthesia
video-assisted thoracic surgery
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Each patient enrolled in the Bi-block group were matched by age, gender and type of surgery with two controls in the TEA group. Patients not-matched were secondarily excluded.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: cumulative morphine consumption on postoperative day 2
timeFrame: postoperative day 2
Secondary outcomes:
measure: non-opioid analgesics consumption on postoperative day 2
timeFrame: postoperative day 2
measure: Pain assessed by visual analog pain scale (VAS)
timeFrame: up to postoperative day 2
measure: Urinary retention
timeFrame: up to postoperative day 2
measure: hypotension
timeFrame: up to postoperative day 2
measure: pleural drain duration
timeFrame: up to postoperative day 2
measure: duration of hospitalization
timeFrame: up to postoperative day 2
measure: occurrence of prurit
timeFrame: up to postoperative day 2
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Intensive Care Unit, D - University hospital of Montpellier
Study officials:
affiliation: Montpellier University Hospital
name: Pierre Sentenac, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montpellier University Hospital
name: Pascal H Colson, MD, PhD
role: STUDY_CHAIR
References: