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Interscalene Block and Dysfunction Diaphragmatic (NUMEROBIS)

Primary Purpose

Diaphragmatic Paralysis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Ropivacaine 0.5% Injectable Solution
Ropivacaine 0.1% Injectable Solution
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diaphragmatic Paralysis focused on measuring interscalene block, shoulder surgery, local anesthesic, respiratory function, diaphragmatic dysfunction, echography, locoregional anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Roger Salengro, CHU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group : ropivacaine 0.1%

control group : ropivacaine 0.5%

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 20, 2019
Last Updated
June 17, 2022
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT04173364
Brief Title
Interscalene Block and Dysfunction Diaphragmatic
Acronym
NUMEROBIS
Official Title
Interscalene Block and Dysfunction Diaphragmatic: Effect of Low Volume of Ropivacaine 0,1%. A Randomised, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 29, 2019 (Actual)
Primary Completion Date
September 21, 2020 (Actual)
Study Completion Date
September 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaphragmatic Paralysis
Keywords
interscalene block, shoulder surgery, local anesthesic, respiratory function, diaphragmatic dysfunction, echography, locoregional anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group : ropivacaine 0.1%
Arm Type
Experimental
Arm Description
Interscalene block for arthroscopic shoulder surgery with small volume of low concentration (0.1%) of ropivacaine
Arm Title
control group : ropivacaine 0.5%
Arm Type
Active Comparator
Arm Description
Interscalene block for arthroscopic shoulder surgery with small volume of standard concentration (0.5%) of ropivacaine
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5% Injectable Solution
Other Intervention Name(s)
naropeine 0.5%
Intervention Description
Injectable solution of ropivacaine 0.5%
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.1% Injectable Solution
Other Intervention Name(s)
Naropeine 0.1%
Intervention Description
Dilution of ropivacaine to the concentration of 0.1%
Primary Outcome Measure Information:
Title
Compare the occurrence of hemi-diaphragmatic paresis
Description
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.
Time Frame
1h after interscalene block
Secondary Outcome Measure Information:
Title
Compare the frequency of hemi-diaphragmatic paralysis
Description
Hemi-diaphragmatic paralysis refers to the absence of diaphragmatic movement (or paradoxical movement) in ultrasound during rest ventilation and slow, deep inhalation.
Time Frame
1h after interscalene block
Title
Compare intraoperative analgesia
Description
Total consumption of sufentanil, and Analgesia Nociception Index values (ANI, MetroDoloris, France).
Time Frame
peroperative time
Title
Compare postoperative analgesia
Description
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.
Time Frame
24 hours postoperatively
Title
Compare the ventilatory function (spirometry and snip test).
Description
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.
Time Frame
1h after interscalene block
Title
Compare patient satisfaction
Description
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)
Time Frame
24 to 48 hours postoperatively
Title
Compare the contralateral diaphragmatic stroke
Description
Evaluation of contralateral diaphragmatic compensation (diaphragmatic stroke in ultrasound, comparison of post-ISB time vs. pre-ISB time, expressed in %).
Time Frame
1h after interscalene block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud ALLUIN, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Roger Salengro, CHU
City
Lille
Country
France

12. IPD Sharing Statement

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Interscalene Block and Dysfunction Diaphragmatic

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