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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine Arm | Experimental | 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. |
|
| Reference Arm | Sham Comparator | 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Between surgery and up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | between surgery and 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Pierre GEKIERE, MD | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest | Bordeaux | 33076 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Ropivacaine: 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. |
| FG001 | Reference Arm | 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. Reference: 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Ropivacaine: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants with a VAS score available | Posted | Count of Participants | Participants | Between surgery and up to 48 hours |
|
48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Ropivacaine: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simone Mathoulin-Pélissier, Director of Clinical Trials Unit | Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR | +33 5 56 33 33 33 | s.mathoulin@bordeaux.unicancer.fr |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Individual series of products were prepared by the Pharmacy according to a list (randomization list pre-established by the biostatistics department), which was not accessible to anyone until the results were analyzed. The treatments were sent by the pharmacy to the operating room in the form of pre-filled syringes with no distinguishing marks indicating the treatment group. Blindness was maintained during the evaluation period.
| Reference | Drug | 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. |
|
| BG001 | Reference Arm | 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. Reference: 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Reference Arm | 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. Reference: 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. |
|
|
|
| Secondary | 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). | Participants with available data at 48 hours. | Posted | Mean | Standard Deviation | boluses | between surgery and 48 hours |
|
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Reference Arm | 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. Reference: 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. | 0 | 41 | 0 | 41 | 0 | 41 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |