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Clinical Trials/NCT02865226
NCT02865226CompletedPhase 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 Reims2 sites in 1 country50 target enrollmentStarted: August 16, 2016Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
50
Locations
2
Primary Endpoint
pain

Study 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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