Diaphragmatic Paralysis
Conditions
Keywords
interscalene block, shoulder surgery, local anesthesic, respiratory function, diaphragmatic dysfunction, echography, locoregional anesthesia
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.
Interventions
DRUGRopivacaine 0.5% Injectable Solution
Injectable solution of ropivacaine 0.5%
Dilution of ropivacaine to the concentration of 0.1%
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the occurrence of hemi-diaphragmatic paresis | 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
| Measure | Time frame | Description |
|---|---|---|
| Compare intraoperative analgesia | peroperative time | Total consumption of sufentanil, and Analgesia Nociception Index values (ANI, MetroDoloris, France). |
| Compare postoperative analgesia | 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. |
| Compare the frequency of hemi-diaphragmatic paralysis | 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. |
| Compare patient satisfaction | 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) |
| Compare the contralateral diaphragmatic stroke | 1h after interscalene block | Evaluation of contralateral diaphragmatic compensation (diaphragmatic stroke in ultrasound, comparison of post-ISB time vs. pre-ISB time, expressed in %). |
| Compare the ventilatory function (spirometry and snip test). | 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. |
Countries
France
Outcome results
None listed