Interscalene Block and Dysfunction Diaphragmatic

NCT ID: NCT04173364

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-29
• Study Completion Date: 2020-09-21

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.

Conditions

Diaphragmatic Paralysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group : ropivacaine 0.1%

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

Group Type: EXPERIMENTAL

Ropivacaine 0.1% Injectable Solution

Intervention Type: DRUG

Dilution of ropivacaine to the concentration of 0.1%

control group : ropivacaine 0.5%

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

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.5% Injectable Solution

Intervention Type: DRUG

Injectable solution of ropivacaine 0.5%

Interventions

Ropivacaine 0.5% Injectable Solution

Injectable solution of ropivacaine 0.5%

Intervention Type: DRUG

Ropivacaine 0.1% Injectable Solution

Dilution of ropivacaine to the concentration of 0.1%

Intervention Type: DRUG

Other Intervention Names

naropeine 0.5%; Naropeine 0.1%

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arnaud ALLUIN, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hôpital Roger Salengro, CHU

Lille, , France

Countries

France

Other Identifiers

2019-001984-62

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2018_66

Identifier Type: -

Identifier Source: org_study_id