Double Regional Anesthesia in Video Assisted Thoracoscopy

Anesthesia Clinical Trial

— DRAVATS  

Official title:

Double Regional Anesthesia in Video Assisted Thoracoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03852862
• Other study ID #: 2017/182/HP
• Status: Completed
• Phase: Phase 4
• Start date: May 8, 2019
• Est. completion date: November 10, 2020

Study information

• Verified date: October 2021
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Monocentric, randomized, controlled, single-blind study who's aim is to demonstrate the efficacy of the association of paravertebral block and serratus plane block with paravertebral block alone

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 10, 2020
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient aged 18 to 75 years;
• Programmed for unilateral videothoracoscopy for anatomical resection (segmentectomy, lobectomy);
• Subject affiliated to a social security scheme;
• Subject having signed an informed consent

Exclusion Criteria:

• Chronic treatment with opiates;
• Contraindication to administration of morphine;
• Allergy to local anesthetics or contraindications to the use of ropivacaine;
• Contraindication to the realization of paravertebral blocks and serratus;
• Pregnancy, breastfeeding;
• Severe obesity (BMI > 40 kg/m²);
• Renal impairment (GFR < 30 mL/min) or known severe hepatic impairment;
• Difficulties of comprehension preventing the collection of consent and the realization of the study;

Related Conditions & MeSH terms

• Anesthesia
• Video Assisted Thoracoscopy

Intervention

Drug:
• Serratus plane block and paravertebral block
Single Administration of 20 mL of ropivacaine for Serratus plane block (Intra-muscular injection) followed by a single administration of 20 ml ropivacaine for paravertebral block (T4 inter-vertebral injection)
• paravertebral block
Single Administration of 20 ml of ropivacaine for paravertebral block (T4 inter-vertebral injection)

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of opioids drug administrated		24 hours postoperatively
Secondary	Length of stay in recovery room		24 hours postoperatively
Secondary	Total duration of hospitalization		during the 28 days postoperatively