Thoracic surgery for pulmonary anatomic resection MedDRA version: 20.0 Level: PT Classification code 10077488 Term: Pulmonary resection System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: ROPIVACAINE KABI
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ROPIVACAINE
CAS Number: 84057-95-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: e
Sponsors
CHU-Hôpitaux de Rouen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient aged 18 to 75 years; • Programmed for unilateral videothoracoscopy for anatomical resection (segmentectomy, lobectomy); • Subject affiliated to a social security scheme; • Subject having signed an informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: • Chronic treatment with opiates; • Contraindication to administration of morphine; • Allergy to local anesthetics or contraindications to the use of ropivacaine; • Contraindication to the realization of paravertebral blocks and serratus; • Pregnancy, breastfeeding; • Severe obesity (BMI > 40 kg/m²); • Renal impairment (GFR < 30 mL/min) or known severe hepatic impairment; • Difficulties of comprehension preventing the collection of consent and the realization of the study; • Emergency situation; • Safeguard of justice, guardianship, curatorship; • Patient participation in another therapeutic trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of the association of paravertebral block and serratus plane block with paravertebral block alone;Secondary Objective: To evaluate the pain during the first 24 hours post surgery, the length of stay in recovery room and total duration of hospitalization, the side effects of morphine and local anesthesics, the residual pain and quality of life after one month and the consumption of other analgesics during the first month post surgery;Primary end point(s): Consumption of opioids over the first 24 hours postoperatively;Timepoint(s) of evaluation of this end point: 24 hours post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - VAS at H0 - H '- H12 -H24 - Length of stay in recovery room and total duration of hospitalization - Side effects of morphine and local anesthesics treatment: nausea, bradypnea, cardiac rhythmic disorders, urinary retention - Residual pain at 1 month - Quality of life at 1 month evaluated by QoL SF-12 questionnaire - Consumption of analgesics of palliate I and II during the first month post-surgery ;Timepoint(s) of evaluation of this end point: H0 - H '- H12 -H24 | — |
Countries
France
Contacts
Public ContactBlot
CHU-Hôpitaux de Rouen
Outcome results
None listed