Double regional anesthesia in video assisted thoracoscopy

Phase 1

• Conditions: 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; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2018-001343-31-FR
• Lead Sponsor: CHU-Hôpitaux de Rouen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-19
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 112

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the efficacy of the association of paravertebral block and serratus plane block with paravertebral block alone;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 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

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): - VAS at H0 - H '- H12 -H24<br> - Length of stay in recovery room and total duration of hospitalization<br> - Side effects of morphine and local anesthesics treatment: nausea, bradypnea, cardiac rhythmic disorders, urinary retention<br> - Residual pain at 1 month<br> - Quality of life at 1 month evaluated by QoL SF-12 questionnaire<br> - Consumption of analgesics of palliate I and II during the first month post-surgery<br> ;Timepoint(s) of evaluation of this end point: H0 - H '- H12 -H24