Clinical trial NCT04222010: Serratus Plain Block Versus Paravertebral Block Versus Serratus Plain Block and Paravertebral Block for Postoperative Pain Following Thoracoscopic Surgery
Official title: Serratus Plain Block Versus Paravertebral Block Versus Serratus Plain Block and Paravertebral Block for Postoperative Pain Following Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Anesthesia, Local
Pain, Postoperative
Keywords: Anesthesia, Local
Pain, Postoperative
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute and chronic postoperative pain remains a major concern following thoracoscopic surgery. Firstly because pain constitutes a serious concern for patients after surgery, and secondarily because an ineffective control of pain may lead to postoperative morbidity, especially in lung cancer surgery.

To date, several procedures have been described but the best modality of locoregional analgesia for thoracoscopic surgery has not been assessed yet. The main objective of this study is to evaluate efficiency of several validated approaches for preoperative locoregional analgesia, comparing serratus plain block versus paravertebral block versus serratus plain block and paravertebral block for postoperative pain following thoracoscopic surgery.

To this end, the investigators will conduct an interventional prospective monocentric, double blind, compared and randomized study. Previously to thoracoscopic surgery, patients will be randomized in one of the three following arms: serratus plain block, paravertebral block or serratus plain block and paravertebral block combined.


Eligibility criteria: Inclusion Criteria:

* adult patient over18 years old
* without guardianship
* video-assisted thoracoscopic surgery with 3 trocars
* No cons-indications to loco-regional anesthesia (allergy, skin condition)

Exclusion Criteria:

* patient under 18 years old
* patient under guardianship
* pregnant
* rejection of consent
* rejection of loco-regional anesthesia
* chronic pain antecedents under morphine medication
* pain assessment impossible

Primary outcomes:
measure: Pain Visual analog scale (VAS) score at coughing
timeFrame: Immediately after following thoracoscopic surgery
Secondary outcomes:
measure: Pain Visual analog scale (VAS) score at coughing
timeFrame: H1 = one hour following thoracoscopic surgery
measure: Pain Visual analog scale (VAS) score at coughing
timeFrame: H3 = 3 hours following thoracoscopic surgery
measure: Pain Visual analog scale (VAS) score at coughing
timeFrame: H6 = 6 hours following thoracoscopic surgery
measure: Pain Visual analog scale (VAS) score at coughing
timeFrame: Day1 = one day following thoracoscopic surgery
measure: Pain Visual analog scale (VAS) score at coughing
timeFrame: Day2 = two days following thoracoscopic surgery
measure: Pain Visual analog scale (VAS) score at coughing
timeFrame: Day3 = 3 days following thoracoscopic surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Pascal Berna, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Emmanuel Lorne, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Alex Fourdrain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Florent Leviel, MD
role: PRINCIPAL_INVESTIGATOR
References: