DRAVATS: Double Regional Anesthesia in Video Assisted Thoracoscopy

• Sponsor: University Hospital, Rouen (Other)
• Overall Status: Completed
• CT.gov ID: NCT03852862
• Collaborator: (none)
• Enrollment: 112
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.1
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Video Assisted Thoracoscopy; Anesthesia	Drug: Serratus plane block and paravertebral block; Drug: paravertebral block	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double Regional Anesthesia in Video Assisted Thoracoscopy
• Actual Study Start Date: May 8, 2019
• Actual Primary Completion Date: Nov 10, 2020
• Actual Study Completion Date: Nov 10, 2020

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Number of opioids drug administrated [24 hours postoperatively]

Secondary Outcome Measures

1. Length of stay in recovery room [24 hours postoperatively]

2. Total duration of hospitalization [during the 28 days postoperatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rouen University Hospital	Rouen		France

Sponsors and Collaborators

• University Hospital, Rouen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Rouen
• ClinicalTrials.gov Identifier: NCT03852862
• Other Study ID Numbers: 2017/182/HP
• First Posted: Feb 25, 2019
• Last Update Posted: Oct 12, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 12, 2021