Lung Cancer Clinical Trial
— ANESSTEVATSOfficial 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.
Verified date | September 2020 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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. |
Country | Name | City | State |
---|---|---|---|
France | Intensive Care Unit, D - University hospital of Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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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