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Clinical Trials/NCT02865226
NCT02865226
Completed
Phase 3

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)

CHU de Reims1 site in 1 country50 target enrollmentAugust 16, 2016
ConditionsPain

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Pain
Sponsor
CHU de Reims
Enrollment
50
Locations
1
Primary Endpoint
pain
Status
Completed
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 16, 2016
End Date
September 1, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

pain

Time Frame: 24 hours

Pain evaluated using a visual analog pain scale

Study Sites (1)

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