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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04983836
Other study ID # 19-AOI-04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 5, 2021
Est. completion date December 15, 2022

Study information

Verified date June 2023
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Currently, the 2 main techniques of regional loco anesthesia in perioperative analgesic management of the thoracotomy remains the establishment of a thoracic epidural or paravertebral block. On the other hand, there is no standard of perioperative analgesic management in the case of thoracic surgery under video-thoracoscopy. The video-thoracoscopy, by its mini-invasive character, makes the levels of pain lower in post-operative questioning the benefit/risk balance of the paravertebral block. In 2013, Blanco published a new technique of locoregional anesthesia called the block Serratus allowing analgesia of a homolateral thorax hemi The latter by its simplicity of realization and its lesser risk is growing in thoracic surgery. This pilot study finds an equivalence in total oxycodone consumption in the first 2 post-operative days with a number of complications related to the serratus block lower than the serratus block compared to the paravertebral block in preoperative surgery.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date December 15, 2022
Est. primary completion date December 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > 18 years - Patient who has given their free, informed and signed consent - Social security affiliation; Exclusion Criteria: - pregnant woman - guardianship / curatorship / private patient under public law - surgery to be performed urgently (less than 24 hours) - surgery redux - thoracotomy surgery - sternotomy surgery - pleurectomy - patient participating simultaneously in another research that may interfere with results of the study - severe abnormality of haemostasis (80,000/ml platelets) and/or coagulation (TP 50%, factor V 50%). - Prior use of morphine; - chronic pain/chest neuropathies - sepsis - patients with insulin-dependent diabetes and/or diabetic neuropathy. - severe kidney or liver failure.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Serratus anesthesia technique
locoregional anaesthesia allowing analgesia of the hemi-thorax by ultrasound guided single injection of naropeine 5mg/ml
Paravertebral anesthesia technique
Ultrasound guided single injection of of naropeine 5mg/ml dose into the paravertebral space next to the thoracic spine

Locations

Country Name City State
France CHU de NICE Nice Toutes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain evaluation Assess the non-inferiority of the single-injection echo-guided serratus block, performed in video-thoracic surgery preoperative, on the post-operative mean pain during the first 48 hours, compared to the single-injection echo-guided paravertebral block with a simple numeric scale (from 0 to 10) 48 hours after the surgery
Secondary Walking test Improvement of walking distance during the test at 6 min post-operative 24 hours after the surgery
Secondary Post operative morphine dose Post operative administrated morphin dose Mesure of intraoperative morphine administrated dose and total morphine administrated dose (in mg). 48 hours after the surgery
Secondary Morphine side effect quantification Collection of adverse reactions due to morphine administration (nausea, vomiting, pruritus, urine retention, respiratory depression) 48 hours after the surgery
Secondary Length of hospitalisation duration Number of hospitalisation days 1 year
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