Cancer, Postoperative Pain
Conditions
Keywords
Thoracic surgery, postoperative pain, ropivacaine, inter pleural analgesia
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: 1. To determine the efficacy of inter pleural analgesia 2. To determine the plasmatic concentration of ropivacaine by inter pleural road
Interventions
DRUGRopivacaine
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.
DRUGReference
8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.
Sponsors
Institut Bergonié
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy | 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
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Morphine Consumption Following Lung Surgery by Posterolateral Thoracotomy | between surgery and 48 hours | Morphine consumption during the 48 hours following surgery. Morphine consumption is defined as the number of morphine boluses (1 bolus = 1mg). |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| 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. | 41 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 4 |
Baseline characteristics
| Characteristic | Reference Arm | Total | Ropivacaine Arm |
|---|---|---|---|
| Age, Continuous | 51.4 years STANDARD_DEVIATION 13.6 | 53.9 years STANDARD_DEVIATION 13.4 | 56.1 years STANDARD_DEVIATION 12.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment France | 41 participants | 85 participants | 44 participants |
| Sex: Female, Male Female | 11 Participants | 30 Participants | 19 Participants |
| Sex: Female, Male Male | 30 Participants | 55 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 41 |
| other Total, other adverse events | 0 / 44 | 0 / 41 |
| serious Total, serious adverse events | 0 / 44 | 0 / 41 |
Outcome results
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.
Time frame: Between surgery and up to 48 hours
Population: Participants with a VAS score available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ropivacaine Arm | Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy | 4 Participants |
| Reference Arm | Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy | 3 Participants |
Comparison: Comparison of proportions.p-value: 0.99Fisher Exact
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).
Time frame: between surgery and 48 hours
Population: Participants with available data at 48 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine Arm | Post-operative Morphine Consumption Following Lung Surgery by Posterolateral Thoracotomy | 29.9 boluses | Standard Deviation 23.5 |
| Reference Arm | Post-operative Morphine Consumption Following Lung Surgery by Posterolateral Thoracotomy | 15.6 boluses | Standard Deviation 17.4 |
p-value: 0.69Wilcoxon (Mann-Whitney)