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)

NCT02865226 | Completed Phase 3

• 1 other identifier: PA15082
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

thoracic surgery; thoracotomy

Outcome Measures

Primary Outcomes (1)

• pain

  Pain evaluated using a visual analog pain scale

  24 hours

Study Arms (2)

experimental group

EXPERIMENTAL

paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound)

Other: paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound)

control group

ACTIVE COMPARATOR

paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual)

Other: paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual).

Interventions

paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound) OTHER

experimental group

paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual). OTHER

control group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu de Reims

Reims, 51092, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 12, 2016
• Study Start: August 16, 2016
• Primary Completion: October 10, 2020
• Study Completion: September 1, 2021
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

FR (1)