Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery (ROPAL-1)

Institut Bergonié

Status and phase: Completed; Phase 2

Conditions: Postoperative Pain; Cancer

Treatments: Drug: Ropivacaine; Drug: Reference

Study type: Interventional

Funder types: Other

Identifiers

NCT00210132

IB2003-23

Details and patient eligibility

About

Thoracic surgery via posterolateral thoracotomy causes significant postoperative pain.

There are several methods of postoperative pain relief, including intravenous analgesics and local-regional analgesia techniques. Although thoracic epidural remains the gold standard, it is not without complications, which are rare but serious, and should be reserved for trained teams or patients with high morbidity.

Intrapleural analgesia is a simple method, performed by the surgeon intraoperatively.

Its effectiveness is controversial and the results remain inconsistent. Ropivacaine is a recently marketed local anesthetic with a modest vasoconstrictive effect. The variation in plasma levels of ropivacaine obtained by this technique has not yet been evaluated.

The purposes of this study are:

1. To determine the efficacy of inter pleural analgesia
2. To determine the plasmatic concentration of ropivacaine by inter pleural road

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Thoracotomy for oncology thoracic surgery
• Secondary or primary cancer
• American Society of Anesthesiology (ASA) class 1 or 2

Exclusion criteria

• Ropivacaine hypersensibility
• Psychiatric disorders
• Incapacity of using visual analog scale

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

90 participants in 2 patient groups

Ropivacaine Arm

Experimental group

Description:

ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours.

Treatment:

Drug: Ropivacaine

Reference Arm

Sham Comparator group

Description:

8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.

Treatment:

Drug: Reference