Double Regional Anesthesia in Video Assisted Thoracoscopy (DRAVATS)

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

Study Overview

• Status: Completed
• Conditions: Anesthesia; Video Assisted Thoracoscopy
• Intervention / Treatment: Drug: Serratus plane block and paravertebral block; Drug: paravertebral block

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Rouen, France
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Serratus plane block with paravertebral block; Association of Serratus plane block and paravertebral block for anesthesia	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)
Active Comparator: paravertebral block alone; Paravertebral block for anesthesia	Drug: paravertebral block; Single Administration of 20 ml of ropivacaine for paravertebral block (T4 inter-vertebral injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of opioids drug administrated	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of stay in recovery room	24 hours postoperatively
Total duration of hospitalization	during the 28 days postoperatively

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Marie-Melody DUSSEAUX, MD, Rouen University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2019
• Primary Completion (Actual): November 10, 2020
• Study Completion (Actual): November 10, 2020

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2017/182/HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No