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

NCT01082744 | Completed Phase 3 DMC

• 2 other identifiers: 2009.5582009-014832-38
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative

Keywords

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

Outcome Measures

Primary Outcomes (1)

• morphine consumption during the first 48 hours

  48 hours

Secondary Outcomes (4)

• Acute pain

  48 hours

• Biological measurements

  48 hours

• Patient satisfaction

  48 hours

• Chronic pain

  3 and 6 monthes

Study Arms (2)

Continuous paravertebral block with ropivacaine

ACTIVE COMPARATOR

Drug: Ropivacaine

Continuous paravertebral block with ropivacaine and sufentanil

EXPERIMENTAL

Drug: Ropivacaine + Sufentanil

Interventions

Ropivacaine + Sufentanil 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

Continuous paravertebral block with ropivacaine and sufentanil

Ropivacaine 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

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69500, France

Location

Related Publications (1)

• 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.

  PMID: 29373333 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain

Interventions

Ropivacaine; Sufentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Christian BAUER, MD

  Hospices Civils de Lyon, Hopital Louis Pradel

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 9, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)