Double Regional Anesthesia in Video Assisted Thoracoscopy

NCT03852862 | Completed Phase 4

• 1 other identifier: 2017/182/HP
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Conditions

Video Assisted Thoracoscopy; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Number of opioids drug administrated

  24 hours postoperatively

Secondary Outcomes (2)

• Length of stay in recovery room

  24 hours postoperatively

• Total duration of hospitalization

  during the 28 days postoperatively

Study Arms (2)

Serratus plane block with paravertebral block

EXPERIMENTAL

Association of Serratus plane block and paravertebral block for anesthesia

Drug: Serratus plane block and paravertebral block

paravertebral block alone

ACTIVE COMPARATOR

Paravertebral block for anesthesia

Drug: paravertebral block

Interventions

Serratus plane block and paravertebral block DRUG

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)

Serratus plane block with paravertebral block

paravertebral block DRUG

Single Administration of 20 ml of ropivacaine for paravertebral block (T4 inter-vertebral injection)

paravertebral block alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

Related Publications (1)

• Dusseaux MM, Grego V, Baste JM, Besnier E, Boujibar F, Koscianski G, Ben Yahia MM, Compere V, Clavier T, Vannier M, Selim J. Paravertebral block combined with serratus anterior plane block after video-assisted thoracic surgery: a prospective randomized controlled trial. Eur J Cardiothorac Surg. 2023 Jul 3;64(1):ezad170. doi: 10.1093/ejcts/ezad170.

  PMID: 37094177 RESULT

Study Officials

• Marie-Melody DUSSEAUX, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 25, 2019
• Study Start: May 8, 2019
• Primary Completion: November 10, 2020
• Study Completion: November 10, 2020
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

FR (1)