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Thoracic Paravertebral Block for Postoperative Analgesia After Video-assisted Thoracic Surgery.

NCT ID: NCT01082744

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-12-31

Brief Summary

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The use of paravertebral catheters is a recommended technique to achieve postoperative analgesia after thoracic surgery. To date there is no consensus on which drug regime (local anesthetics with or without opioid) is best. The aim of this prospective clinical trial is to determine wether the use of ropivacaine and sufentanil injected through a thoracic paravertebral catheter results in decreased acute postoperative pain compared with plain ropivacaine in patients after thoracoscopic lung surgery.

Detailed Description

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Conditions

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Pain, Postoperative

Keywords

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Paravertebral Block Regional Anesthesia Anesthetics Local Ropivacaine Sufentanil Pain Postoperative Chronic Pain Thoracic Surgery Video-Assisted.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Continuous paravertebral block with ropivacaine

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours

Continuous paravertebral block with ropivacaine and sufentanil

Group Type EXPERIMENTAL

Ropivacaine + Sufentanil

Intervention Type DRUG

Sufentanil at 0.25 µg/ml added to ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours

Interventions

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Ropivacaine + Sufentanil

Sufentanil at 0.25 µg/ml added to ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours

Intervention Type DRUG

Ropivacaine

Ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient scheduled for planned video-assisted thoracic surgery
* Patient that consent to participate
* Planned placement of paravertebral catheter
* Patient having a medical insurance

Exclusion Criteria

* Patient less than 18 years
* Refusal to participate
* Known pregnancy
* Known allergies to local anesthetics, sufentanil and /or to iodinated contrast material
* Intolerance to sufentanil and/or morphine
* Chronic consumption of opiates
* Preoperative chronic pain syndrome
* Patient having a contraindication to placement of paravertebrtal catheter
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian BAUER, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon, Hopital Louis Pradel

Locations

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Hospices Civils de Lyon, Hopital Louis Pradel, Department of Anesthesiology

Bron, , France

Site Status

Countries

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France

References

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Bauer C, Pavlakovic I, Mercier C, Maury JM, Koffel C, Roy P, Fellahi JL. Adding sufentanil to ropivacaine in continuous thoracic paravertebral block fails to improve analgesia after video-assisted thoracic surgery: A randomised controlled trial. Eur J Anaesthesiol. 2018 Oct;35(10):766-773. doi: 10.1097/EJA.0000000000000777.

Reference Type RESULT
PMID: 29373333 (View on PubMed)

Other Identifiers

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2009-014832-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2009.558

Identifier Type: -

Identifier Source: org_study_id