Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery

Institut Bergonié90 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Postoperative Pain Cancer

Interventions

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.

ReferenceDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

Bordeaux, France

Outcomes

Primary Outcomes

Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy

Pain is measured using a visual analog scale (VAS), ranging from 0 (no pain) to 100 (worst pain ever). A participant is considered to have major pain if VAS score is \>= 70.

Time frame: Between surgery and up to 48 hours

Secondary Outcomes

Post-operative Morphine Consumption Following Lung Surgery by Posterolateral Thoracotomy

Morphine consumption during the 48 hours following surgery. Morphine consumption is defined as the number of morphine boluses (1 bolus = 1mg).

Time frame: between surgery and 48 hours

Data from ClinicalTrials.gov

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