Pain After Shoulder Surgery
Conditions
Keywords
Postoperative pain, Fascial plane block, Infraspinatus-teres minor block
Brief summary
The main study objective is to observe the ability of the ITM block to provide clinically acceptable pain control after elective shoulder arthroscopy as measured by pain scores and morphine consumption. The secondary objectives are determining its trajectory of efficacy up to 24 hours by measure of pain scores, morphine consumption and side effects.
Detailed description
Significant post-operative pain follows shoulder arthroscopy. Currently the interscalene brachial plexus (ISB) block is recommended as the first-choice regional anaesthesia technique (1). However, interscalene bloc is associated with phrenic nerve paralysis for the duration of the block which can exacerbate pulmonary co-morbidities, as well as motor block of the arm which can decrease patient autonomy. An alternative to the interscalene block is the combined suprascapular nerve and axillary nerve (SSAX) block (2). However, this requires two needle punctures and is more difficult to perform technically. Recently, the Infraspinatus Teres Minor Interfascial Plane (ITM) block was developed by Kim et al (1) to anaesthetise the suprascapular and axillary nerves with a single approach. As a fascial plane block, its high safety profile and ease of performance make it a potentially safer alternative the SSAX block when the ISB is contraindicated. A monocentric, prospective Simon two-stage trial
Interventions
OTHERInfraspinatus-teres minor block
A fascial plane block of the posterior shoulder with an injection between the infraspinatus and teres minor muscle which will anesthetise the axillary and supraclavicular nerves.
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A Simon's Two-Stage Design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* The study population inclusion criteria will be: * Patients of any sex * Class ASAI-III * Patients 18 years of age or older * Scheduled for elective shoulder arthroscopy * Able to give written informed consent autonomously * Sex and gender dimensions are irrelevant for this study as enrolled patients are benefitting from shoulder surgery without reference to gender and our standard care as well as our research disposition is indiscriminately applied to all genders.
Exclusion criteria
* The subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic efficacy | At 2 hours postoperatively and at 24 hours postoperatively. | The binary primary endpoint is block success, requiring the two following criteria: 1. Early treatment success: defined as the absence of treatment failure during the initial 2 hours postoperatively. Treatment failure is defined as either the requirement for greater than or equal to 10 mg of intravenous morphine and a VAS pain score \>3, or a VAS pain score of greater than or equal to 7 at any time during this period. 2. Twenty-four-hour analgesic success: defined as a VAS pain score \<4 at 24 hours postoperatively while consuming no more than 30 mg of reserve oral morphine. |
Countries
Switzerland
Contacts
CONTACTProfessor Dr. Med Eric Albrecht, DM, MD
CONTACTCorey A Kull, MD
Outcome results
None listed