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NCT Number: NCT04173364

Interscalene Block and Dysfunction Diaphragmatic

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.

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Key information

Conditions

Diaphragmatic Paralysis Nervous System Diseases Neurologic Manifestations Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Insufficiency Respiratory Paralysis Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Roger Salengro, CHU

Lille, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine 0.5% Injectable Solution

Drug

Injectable solution of ropivacaine 0.5%

Other names: naropeine 0.5%

Ropivacaine 0.1% Injectable Solution

Drug

Dilution of ropivacaine to the concentration of 0.1%

Other names: Naropeine 0.1%

Primary outcomes

  1. Compare the occurrence of hemi-diaphragmatic paresis

    Time frame: 1h after interscalene block

    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.

Secondary outcomes

  1. Compare the frequency of hemi-diaphragmatic paralysis

    Time frame: 1h after interscalene block

    Hemi-diaphragmatic paralysis refers to the absence of diaphragmatic movement (or paradoxical movement) in ultrasound during rest ventilation and slow, deep inhalation.

  2. Compare intraoperative analgesia

    Time frame: peroperative time

    Total consumption of sufentanil, and Analgesia Nociception Index values (ANI, MetroDoloris, France).

  3. Compare postoperative analgesia

    Time frame: 24 hours postoperatively

    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.

  4. Compare the ventilatory function (spirometry and snip test).

    Time frame: 1h after interscalene block

    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.

  5. Compare patient satisfaction

    Time frame: 24 to 48 hours postoperatively

    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)

  6. Compare the contralateral diaphragmatic stroke

    Time frame: 1h after interscalene block

    Evaluation of contralateral diaphragmatic compensation (diaphragmatic stroke in ultrasound, comparison of post-ISB time vs. pre-ISB time, expressed in %).

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: NUMEROBIS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 21, 2019
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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