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

Civil Hospices of Lyon

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Ropivacaine; Drug: Ropivacaine + Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT01082744

2009.558

2009-014832-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

90 participants in 2 patient groups

Continuous paravertebral block with ropivacaine

Active Comparator group

Treatment:

Drug: Ropivacaine

Continuous paravertebral block with ropivacaine and sufentanil

Experimental group

Treatment:

Drug: Ropivacaine + Sufentanil