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SERRATHOR TRIAL : Interest of the Novel Serratus Plane Block in Post Operative Analgesia After Video-Assisted Thoracoscopic Lobectomy (SERRATHOR)

Primary Purpose

Video Assisted Thoracoscopic Surgery, Lobectomy, Pain Post Operative

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ropivacaine
sterile saline
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Video Assisted Thoracoscopic Surgery focused on measuring Serratus plane block, Analgesia after VATS, Lobectomy VATS

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • All patients undergoing lobectomy VATS
  • Older > 18 years
  • Patients who meet criteria of ASA 1 to 3 class

Exclusion criteria:

  • Patient's refusal to participate in the study
  • Psychiatric disorder (impossibility to collect the informed consent)
  • Patient under juridical protection
  • On going an other study
  • Non balanced epilepsy
  • 3 grade auriculo-ventricular heart block without pacing
  • Severe hepatocellular insufficiency
  • Anti arrhythmic treatment : class III of the Vaughan William's classification
  • Pregnant patient or/and breastfeeding
  • History of opioid abuse
  • Allergy to local anesthetic drug or opioids

Sites / Locations

  • Les Hôpitaux Universitaires de Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Serratus Block

Placebo Block - Control Group

Arm Description

At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered. Under ultrasonography assistance, block will be performed at the fifth rib in the midaxillary line. Local anesthetic will be injected either superficial to the serratus anterior muscle or deep underneath the muscle. Anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product.

Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution. Under ultrasonography assistance, placebo will be injected at the fifth rib in the midaxillary line, either superficial to the serratus anterior muscle or deep underneath the muscle. Anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of sterile saline will be prepared identically by the central pharmacy, without any possible identification of the product.

Outcomes

Primary Outcome Measures

Total intravenous morphine consumption (mg) in the PACU and department.
Including the dose of titration while the patient is in PACU and PCA up to 24h postoperatively.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2019
Last Updated
June 3, 2019
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT03867695
Brief Title
SERRATHOR TRIAL : Interest of the Novel Serratus Plane Block in Post Operative Analgesia After Video-Assisted Thoracoscopic Lobectomy
Acronym
SERRATHOR
Official Title
SERRATHOR Trial : Analgesic Effect of Serratus Plane Block After Video-Assisted Thoracoscopic Surgery Lobectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pain after thoracic surgery remains a challenge for anesthetists. Although VATS for lobectomy is associated with fewer complications compared to thoracotomy, pain after VATS needs to be treated with opioids. Opioids may lead to PONV, respiratory depression, sedation and pruritus. As part of multimodal analgesia and opioids sparing, several local regional techniques has been described: paravertebral block, thoracic epidural analgesia, intercostal block. To date, there is no gold standard for regional anesthesia after VATS. Serratus plane block is a local regional technique, recently described for analgesia after breast surgery and ribs fracture. In our hospital center, since 2016, we used the Serratus plane block for patients scheduled for lobectomy VATS : a local retrospective trial showed that SPB was associated with a lower consumption of morphine. The purpose of this randomized controlled double blinded study is to evaluate the analgesic effect of the Serratus plane block, added to a general anesthesia on post operative pain control after VATS lobectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Video Assisted Thoracoscopic Surgery, Lobectomy, Pain Post Operative, Regional Anesthesia
Keywords
Serratus plane block, Analgesia after VATS, Lobectomy VATS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Serratus Block
Arm Type
Experimental
Arm Description
At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered. Under ultrasonography assistance, block will be performed at the fifth rib in the midaxillary line. Local anesthetic will be injected either superficial to the serratus anterior muscle or deep underneath the muscle. Anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product.
Arm Title
Placebo Block - Control Group
Arm Type
Placebo Comparator
Arm Description
Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution. Under ultrasonography assistance, placebo will be injected at the fifth rib in the midaxillary line, either superficial to the serratus anterior muscle or deep underneath the muscle. Anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of sterile saline will be prepared identically by the central pharmacy, without any possible identification of the product.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered.
Intervention Type
Drug
Intervention Name(s)
sterile saline
Intervention Description
Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution
Primary Outcome Measure Information:
Title
Total intravenous morphine consumption (mg) in the PACU and department.
Description
Including the dose of titration while the patient is in PACU and PCA up to 24h postoperatively.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: All patients undergoing lobectomy VATS Older > 18 years Patients who meet criteria of ASA 1 to 3 class Exclusion criteria: Patient's refusal to participate in the study Psychiatric disorder (impossibility to collect the informed consent) Patient under juridical protection On going an other study Non balanced epilepsy 3 grade auriculo-ventricular heart block without pacing Severe hepatocellular insufficiency Anti arrhythmic treatment : class III of the Vaughan William's classification Pregnant patient or/and breastfeeding History of opioid abuse Allergy to local anesthetic drug or opioids
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bob HEGER
Phone
+33 3.69.55.04.43
Email
Bob.Heger@chru-strasbourg.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gharib AJOB
Phone
+33 3.69.55.07.92
Email
Gharib.ajob@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bob HEGER
Organizational Affiliation
Les Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Les Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bob HEGER
Phone
+33 3.69.55.04.43
Email
Bob.Heger@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Bob HEGER
First Name & Middle Initial & Last Name & Degree
Gharib AJOB
First Name & Middle Initial & Last Name & Degree
Annick STEIB
First Name & Middle Initial & Last Name & Degree
Paul-Michel MERTES
First Name & Middle Initial & Last Name & Degree
Olivier HELMS
First Name & Middle Initial & Last Name & Degree
Fayçal EL MILOUDI
First Name & Middle Initial & Last Name & Degree
François FISCHER
First Name & Middle Initial & Last Name & Degree
Cécile GROS
First Name & Middle Initial & Last Name & Degree
Francois LEVY
First Name & Middle Initial & Last Name & Degree
Pierre-Emmanuel FALCOZ
First Name & Middle Initial & Last Name & Degree
Nicolas SANTELMO

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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SERRATHOR TRIAL : Interest of the Novel Serratus Plane Block in Post Operative Analgesia After Video-Assisted Thoracoscopic Lobectomy

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