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

Regional Anesthesia Clinical Trial

— SERRATHOR  

Official title:

SERRATHOR Trial : Analgesic Effect of Serratus Plane Block After Video-Assisted Thoracoscopic Surgery Lobectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03867695
• Other study ID #: 6755
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2019
• Est. completion date: July 2020

Study information

• Verified date: March 2019
• Source: University Hospital, Strasbourg, France
• Contact: Bob HEGER
• Phone: +33 3.69.55.04.43
• Email: Bob.Heger[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: July 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Lobectomy
• Pain Post Operative
• Pain, Postoperative
• Regional Anesthesia
• Video Assisted Thoracoscopic Surgery

Intervention

Drug:
• Ropivacaine
At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered.
• sterile saline
Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours