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Phase 2 N=90 Randomized Triple-blind Treatment

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

Postoperative Pain · Cancer

Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy — 4; 3 Participants — p=0.99

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Ropivacaine (Drug); Reference (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Institut Bergonié
Primary completion
Jun 2006

Outcome Measures

OutcomeResultp-value
PRIMARY
Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy
4; 3 0.99
SECONDARY
Post-operative Morphine Consumption Following Lung Surgery by Posterolateral Thoracotomy
29.9; 15.6 0.69

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

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00210132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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