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

Lung Cancer Clinical Trial

— ANESSTEVATS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538235
• Other study ID #: RECHMPL19_0473
• Status: Completed
• Start date: October 20, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Thoracic 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.

Locations

Country	Name	City	State
France	Intensive Care Unit, D - University hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative morphine consumption on postoperative day 2	cumulative morphine consumption on postoperative day 2, including the morphine administered in Post anesthesia care unit (PACU), on postoperative day 0, 1 and 2.	postoperative day 2
Secondary	non-opioid analgesics consumption on postoperative day 2	Paracetamol, Tramadol, Ketoprofen, Nefopam cumulative consumption on POD 2.	postoperative day 2
Secondary	Pain assessed by visual analog pain scale (VAS)	mean VAS, maximal VAS, number of events with a VAS > 3	up to postoperative day 2
Secondary	Urinary retention		up to postoperative day 2
Secondary	hypotension		up to postoperative day 2
Secondary	pleural drain duration		up to postoperative day 2
Secondary	duration of hospitalization		up to postoperative day 2
Secondary	occurrence of prurit		up to postoperative day 2