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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04538235
Other study ID # RECHMPL19_0473
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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