Interscalene Block and Dysfunction Diaphragmatic (NUMEROBIS)

University Hospital, Lille

Status and phase: Completed; Phase 3

Conditions: Diaphragmatic Paralysis

Treatments: Drug: Ropivacaine 0.1% Injectable Solution; Drug: Ropivacaine 0.5% Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04173364

2019-001984-62 (EudraCT Number)

2018_66

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Experimental group : ropivacaine 0.1%

Experimental group

Description:

Interscalene block for arthroscopic shoulder surgery with small volume of low concentration (0.1%) of ropivacaine

Treatment:

Drug: Ropivacaine 0.1% Injectable Solution

control group : ropivacaine 0.5%

Active Comparator group

Description:

Interscalene block for arthroscopic shoulder surgery with small volume of standard concentration (0.5%) of ropivacaine

Treatment:

Drug: Ropivacaine 0.5% Injectable Solution