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

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ClinicalTrials.gov Identifier: NCT03867695
Recruitment Status : Not yet recruiting
First Posted : March 8, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.


Condition or disease Intervention/treatment Phase
Video Assisted Thoracoscopic Surgery Lobectomy Pain Post Operative Regional Anesthesia Drug: Ropivacaine Drug: sterile saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: SERRATHOR Trial : Analgesic Effect of Serratus Plane Block After Video-Assisted Thoracoscopic Surgery Lobectomy
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Serratus Block

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.

Drug: Ropivacaine
At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered.

Placebo Comparator: Placebo Block - Control Group

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.

Drug: sterile saline
Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution




Primary Outcome Measures :
  1. Total intravenous morphine consumption (mg) in the PACU and department. [ Time Frame: 24 hours ]
    Including the dose of titration while the patient is in PACU and PCA up to 24h postoperatively.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867695


Contacts
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Contact: Bob HEGER +33 3.69.55.04.43 Bob.Heger@chru-strasbourg.fr
Contact: Gharib AJOB +33 3.69.55.07.92 Gharib.ajob@chru-strasbourg.fr

Locations
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France
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Contact: Bob HEGER    +33 3.69.55.04.43    Bob.Heger@chru-strasbourg.fr   
Principal Investigator: Bob HEGER         
Sub-Investigator: Gharib AJOB         
Sub-Investigator: Annick STEIB         
Sub-Investigator: Paul-Michel MERTES         
Sub-Investigator: Olivier HELMS         
Sub-Investigator: Fayçal EL MILOUDI         
Sub-Investigator: François FISCHER         
Sub-Investigator: Cécile GROS         
Sub-Investigator: Francois LEVY         
Sub-Investigator: Pierre-Emmanuel FALCOZ         
Sub-Investigator: Nicolas SANTELMO         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Bob HEGER Les Hôpitaux Universitaires de Strasbourg
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03867695    
Other Study ID Numbers: 6755
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Serratus plane block
Analgesia after VATS
Lobectomy VATS
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents