Interscalene Block and Dysfunction Diaphragmatic

Diaphragmatic Paralysis Clinical Trial

— NUMEROBIS  

Official title:

Interscalene Block and Dysfunction Diaphragmatic: Effect of Low Volume of Ropivacaine 0,1%. A Randomised, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04173364
• Other study ID #: 2018_66
• Secondary ID: 2019-001984-62
• Status: Completed
• Phase: Phase 3
• Start date: October 29, 2019
• Est. completion date: September 21, 2020

Study information

• Verified date: June 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 21, 2020
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diaphragmatic Paralysis
• Paralysis
• Respiratory Paralysis

Intervention

Drug:
• Ropivacaine 0.5% Injectable Solution
Injectable solution of ropivacaine 0.5%
• Ropivacaine 0.1% Injectable Solution
Dilution of ropivacaine to the concentration of 0.1%

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the occurrence of hemi-diaphragmatic paresis	Hemi diaphragmatic paresis is evaluated by quantifying the homolateral diaphragmatic stroke at interscalene block (ISB) by ultrasound analysis (measured in centimeter), during slow and deep inspiration. Diaphragmatic hemiparesis is defined as a decrease (at post-ISB time vs. pre-ISB time) of more than 25% of the diaphragmatic stroke during this slow and deep inspiration.	1h after interscalene block
Secondary	Compare the frequency of hemi-diaphragmatic paralysis	Hemi-diaphragmatic paralysis refers to the absence of diaphragmatic movement (or paradoxical movement) in ultrasound during rest ventilation and slow, deep inhalation.	1h after interscalene block
Secondary	Compare intraoperative analgesia	Total consumption of sufentanil, and Analgesia Nociception Index values (ANI, MetroDoloris, France).	peroperative time
Secondary	Compare postoperative analgesia	Duration of effective analgesia (defined as the period up to the first EVA > 3 (excluding PACU Consumption of morphine in PACU and analgesics within the first 24 hours.	24 hours postoperatively
Secondary	Compare the ventilatory function (spirometry and snip test).	Presence of a respiratory impairment detected by spirometry (Spiro-USB® device) and presence of a diaphragmatic impairment detected by snip test, (micro-RPM®). Ventilation impairment will be considered present if there is a decrease of at least 25% in vital capacity between the pre and post ISB. Diaphragmatic damage is defined as a decrease of at least 25% in the Snip-test values between the pre and post ISB.	1h after interscalene block
Secondary	Compare patient satisfaction	Evaluation of patient satisfaction by questionnaire at the patient's bedside or by telephone call within 24h-48h postoperatively. It is assessed on a numerical scale from 0 to 10 (0 being the lowest satisfaction value and 10 the highest value)	24 to 48 hours postoperatively
Secondary	Compare the contralateral diaphragmatic stroke	Evaluation of contralateral diaphragmatic compensation (diaphragmatic stroke in ultrasound, comparison of post-ISB time vs. pre-ISB time, expressed in %).	1h after interscalene block