Comparison of the Clinical Efficacy of 2 Paravertebral Block Strategies in Thoracic Surgery by Thoracotomy: by the Anesthetist (Paravertebral Block Guided by Ultrasound) and by the Thoracic Surgeon (Paravertebral Block Visual)

Phase 3

Completed

• Conditions: Pain
• Interventions: Other: paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound); Other: paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual).

• Registration Number: NCT02865226
• Lead Sponsor: CHU de Reims

Brief Summary

Post-thoracotomy pain is one of the most severe. The local analgesia allows its effective control and a reduction of postoperative morbidity and mortality.

The gold standard for local analgesia is the thoracic epidural. However, this technique can be dangerous with severe complications.

The paravertebral block showed comparable efficacy to the thoracic epidural for local analgesia . In addition, it has a better safety profile. There are several installation techniques. The difference in efficiency of these laying techniques is unknown.

Detailed Description

Compare the clinical effectiveness of two strategies of realization of paravertebral block: by the anesthetist before incision (paravertebral block guided by ultrasound) and by the thoracic surgeon at chest closure (paravertebral block visual).

Study Timeline

• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-12
• Study Start: 2016-08-16
• Primary Completion: 2020-10-10
• Study Completion: 2021-09-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patient with thoracotomy indication for segmentectomy (s), lobectomy (s) lung or pulmonary wedge resection
• patient consenting to participate to the study
• patient enrolled in the national healthcare insurance program
• patient older than 18 years

Exclusion Criteria

• patient with neuropathy
• patient with body mass index superior to 35 kg/m2
• patient with contraindication for paravertebral block or local analgesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound)	paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound)
control group	paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual).	paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual)

Primary Outcome Measures

Name	Time	Method
pain	24 hours	Pain evaluated using a visual analog pain scale

Trial Locations

Locations (1)

Chu de Reims; 🇫🇷 Reims, France