Ignite Creation Date:
2024-05-06 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03691922
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2018-09-18
Brief Title:
Erector Spinae Block Versus Shoulder Periarticular Anesthetic Infiltration for Arthroscopic Shoulder Surgery
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Randomized Control Trial of Ultrasound-Guided Erector Spinae Block Versus Shoulder Periarticular Anesthetic Infiltration for Pain Control After Arthroscopic Shoulder Surgery
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Arthroscopic shoulder surgery is a common and minimally invasive procedure utilized for different shoulder pathologies but it is often associated with moderate to severe postoperative pain that may interfere with patients well-being and course of recovery By using an effective analgesic technique with few side effects a patient may experience less pain after surgery have a shortened hospital stay and endure less nausea vomiting or excessive drowsiness that are associated with the use of opioids to manage postoperative pain Periarticular infiltration PAI with local anesthetic LA has been used for shoulder surgery pain management but the more effective interscalene nerve block ISNB is the current gold standard analgesic modality despite risk of significant side effects including diaphragm paralysis and rebound pain In this study the investigators want to look at the effectiveness and safety profile of a novel technique for pain management after shoulder surgery that has the potential to provide successful pain relief with minimal risk of side effects Half of the patients will be randomly selected to receive the novel nerve block called the Erector Spinae Plane ESP block while the other half will receive a more standard PAI of local anesthetic to numb the shoulder Patients pain intensity and opioid consumption in the post-anesthesia care unit PACU as well as during the first 24 hours after surgery will be evaluated Any complications from the interventions will also be noted The investigators predict that the ESP block will provide superior analgesia compared to PAI for these shoulder arthroscopy patients
Detailed Description:
The use of opioids to manage immediate postoperative pain is frequently associated with nausea vomiting respiratory depression hormonal effects and dysphoria As such achieving pain control while minimizing opioid use is critical since more than 60 of unplanned prolonged hospitalizations and hospital readmissions are thought to be related to inadequate pain control or to side effects of opioids A number of techniques have been used to achieve good pain control after arthroscopic shoulder surgery including periarticular infiltration PAI with local anesthetic LA and regional anesthetic nerve blocks Although PAI in the shoulder has been shown to decrease shoulder pain and opioid consumption it is not as effective as regional blocks such as the interscalene nerve block ISNB which is the current gold standard Nevertheless the ISNB is potentially associated with significant side effects including persistent neurologic complications rebound pain phrenic nerve palsy respiratory distress cardiac arrest pneumothorax and central nerve toxicity In view of this investigating alternate regional blocks having the potential for good pain relief with minimal side effects is important The Erector Spinae Plane ESP block can be considered as a modification of thoracic paravertebral block PVB that blocks thoracic spinal nerves using injections outside of the conventional paravertebral space It is performed under ultrasound US by injecting local anesthetic deep to the erector spinae muscle at the interfascial space between either the erector spinae muscle and the rhomboid major muscle higher up or between the erector spinae muscle and the external intercostal muscles at lower sites Cadaveric studies of ultrasound-guided ESP blocks with methylene blue dye and subsequent dissection as well an ESP block with a dye mixture and CT scanning demonstrated that when injecting deep into the erector spinae the block likely affects the ventral and dorsal rami leading to the sensory blockade The advantages include its simplicity and safety by limiting the risk of nerve damage and pneumothorax Various case reports have demonstrated the ESP block to be successful for abdominal breast and axillary and other surgery types and a recent case report described the successful management of chronic shoulder pain without motor blockade with ESP performed at T3 level The investigators conducted a systematic review via Pubmed to identify studies that have utilized ESP for post-surgical shoulder pain Out of 77 reports the investigators did not identify any comparative studies looking at the potential of ESP for shoulder surgery pain The investigators also looked into ongoing and proposed trials of ESP by looking into clinicaltrialsgov The investigators identified 21 studies including some randomized controlled trials RCT for thoracic surgery and general surgery population but none for shoulder surgeries Given the importance of providing adequate analgesia for arthroscopic shoulder surgery and lack of consensus amongst surgeons and anesthesiologists for the optimal analgesic technique this trial will help establish the effectiveness of the ESP block in pain control after shoulder arthroscopy and define its safety profile The results of this trial will allow the clinician to inform patients accurately regarding the benefits and risks of the block and thus guide the clinical practice of this block for shoulder arthroscopy If proven to be effective it may be used as an alternative to ISNB especially in cases where ISNB is contraindicated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None