Clinical trial NCT04173364: Interscalene Block and Dysfunction Diaphragmatic
Official title: Interscalene Block and Dysfunction Diaphragmatic: Effect of Low Volume of Ropivacaine 0,1%. A Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diaphragmatic Paralysis
Keywords: interscalene block
shoulder surgery
local anesthesic
respiratory function
diaphragmatic dysfunction
echography
locoregional anesthesia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study seeks to show that interscalene injection of a small volume (\<8ml) of ropivacaine at a low concentration (0.1%) reduces the frequency of hemi-diaphragmatic paresis compared to low volume injection at the standard concentration (0.5%) in patients undergoing arthroscopic shoulder surgery with ISB.

Detailed description: It's a prospective monocentric randomized controlled clinical trial in 2 parallel groups in double blind.

the study concerns patients undergoing arthroscopic shoulder surgery with ISB. The study seeks to show that interscalene injection of a small volume (\<8ml) of ropivacaine at a low concentration (0.1%) reduces the frequency of hemi-diaphragmatic paresis compared to low volume injection at the standard concentration (0.5%) in patients undergoing arthroscopic shoulder surgery with ISB.

Randomization in one of the two arms:

* Experimental group: \<8ml ropivacaine 0.1%.
* Control group: \<8mL of ropivacaine 0.5%.

Evaluation of diaphragmatic stroke by ultrasound and ventilatory function by spirometry and snip test before performing the ISB, then after installation of the ISB.

Performing the surgical procedure under general anesthesia assessment of postoperative analgesia and patient satisfaction during the following 48 hours.

Eligibility criteria: Inclusion Criteria:

* orthopedic surgery compatible with interscalene block
* french speaking
* Patient who signed consent to participate in the study

Exclusion Criteria:

* Pregnant woman
* ASA score \> 3
* Severe chronic respiratory insufficiency
* COPD \>3 or 4 of Gold score
* coagulation trouble
* Allergic to medication involved in the study
* Breastfeeding women

Primary outcomes:
measure: Compare the occurrence of hemi-diaphragmatic paresis
timeFrame: 1h after interscalene block
Secondary outcomes:
measure: Compare the frequency of hemi-diaphragmatic paralysis
timeFrame: 1h after interscalene block
measure: Compare intraoperative analgesia
timeFrame: peroperative time
measure: Compare postoperative analgesia
timeFrame: 24 hours postoperatively
measure: Compare the ventilatory function (spirometry and snip test).
timeFrame: 1h after interscalene block
measure: Compare patient satisfaction
timeFrame: 24 to 48 hours postoperatively
measure: Compare the contralateral diaphragmatic stroke
timeFrame: 1h after interscalene block
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU
Study officials:
affiliation: University Hospital, Lille
name: Arnaud ALLUIN, MD
role: PRINCIPAL_INVESTIGATOR
References: