Randomized Trial to Evaluate the Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery
Overview
- Phase
- Phase 2
- Intervention
- Ropivacaine
- Conditions
- Postoperative Pain
- Sponsor
- Institut Bergonié
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
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:
- To determine the efficacy of inter pleural analgesia
- To determine the plasmatic concentration of ropivacaine by inter pleural road
Investigators
Eligibility Criteria
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
Arms & Interventions
Ropivacaine Arm
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.
Intervention: Ropivacaine
Reference Arm
8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.
Intervention: Reference
Outcomes
Primary Outcomes
Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy
Time Frame: Between surgery and up to 48 hours
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.
Secondary Outcomes
- Post-operative Morphine Consumption Following Lung Surgery by Posterolateral Thoracotomy(between surgery and 48 hours)