Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05908851
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-05
First Post:
2023-04-25
Brief Title:
Perioperative Pain Management for Total Shoulder Arthroplasty A Pilot Non-Inferiority Trial
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Perioperative Pain Management for Total Shoulder Arthroplasty A Pilot Non-Inferiority Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
Total shoulder arthroplasty TSA is a common and effective treatment for end-stage shoulder pathologies Over the past 25 years implant designs have evolved and the indications for joint replacement have expanded significantly to include arthritis rotator cuff arthropathy complex shoulder trauma and trauma sequelae This has resulted in a worldwide increase in rates of shoulder replacement surgery The concomitant increased treatment burden for health care systems has prompted interest in strategies to improve the effectiveness and efficiency of patient care such as streamlining intraoperative procedures mitigating complications and reducing length of stay by providing outpatient surgical care Outpatient lower extremity arthroplasty is commonplace and provides helpful information that can guide the development of outpatient TSA such as careful patient selection and the use of standardized perioperative pain management protocols In lower extremity arthroplasty several authors have described challenges associated with nerve blockade and the advantages of high-volume local infiltration analgesia LIA for outpatient arthroplasty Proponents of outpatient TSA also describe the importance of patient selection standardized perioperative protocols and implementation of comprehensive perioperative pain management strategies that can include the use of perioperative ultrasound guided interscalene brachial plexus blockade with a single shot injection ultrasound guided interscalene brachial plexus blockade with a temporary indwelling catheter ISB LIA near the surgical site and multimodal postoperative analgesics
Detailed Description:
A noninferiority clinical trial will be utilized for the study Eighty patients undergoing primary TSA anatomic or reverse TSA with an orthopaedic surgeon at the Roth McFarlane Hand and Upper Limb Centre will be recruited into the study The study participants n80 will be randomized preoperatively into either 1 the ultrasound guided ISB group n40 or 2 the high-volume LIA group n40 For the pilot study the investigators will also measure recruitment rates time to study completion and drop-out rates
All patients will undergo TSA through a standard deltopectoral approach Postoperative rehabilitation will include routine protocols including sling protection for 6 weeks and the following progressive exercises sling pendulum active-assisted range of motion active range of motion passive range of motion and shoulder girdle strengthening Patients randomized to the ultrasound guided ISB group will receive brachial plexus blockade with 10 ml of 05 ropivacaine using a high frequency linear array transducer Sonosite Edge II FUJIFILM Sonsonite Inc Bothell WA USA Patients randomized to the high-volume LIA group will receive 100 mL of 09 normal saline 57ml 05 ropivacaine 40 ml 10 mg morphine 10 mgml 01 mg of epinephrine 01 mgml and 30 mg of ketorolac 30 mgml divided equally into a 20 ml five-zone field infiltration into the suprascapular notchposterior capsule suprascapular and axillary nerves coracobrachialis muscle anterior deltoid muscle superior pectoralis major muscle and skin incision at the conclusion of the procedure by the treating surgeon Patients will be discharged with a standard prescription of multimodal analgesics including acetaminophen ibuprofen sustained release morphine and short acting opioid
In this case because the LIA option is likely associated with lesser cost and lower risk of adverse events non-inferior effectiveness for pain control would provide sufficient and clear evidence that the LIA is the preferred choice The trial will follow CONSORT reporting guidelines All measures will be administered though our Methods Centre web-based data collection and will be completed in clinic under the direction of a study coordinator If a patient misses a follow-up the web-based system will allow us to capture the outcome measures remotely While investigators have selected multiple secondary outcome measures they reflect important secondary dimensions and are measured with well-validated short forms that have low response burden Potential mediators Sex age gender-related pain expectations occupation and comorbid health status will be recorded as potential covariates Sample size estimation The criteria for sample size requirements for noninferiority trials is based on the smallest difference that is considered clinically relevant and the standard deviation expected from the sample n80 participants n40 per group is a conservative estimate based on the ability to detect a moderate effect between study groups for a mean between-groups difference in the primary outcome
All patients will undergo TSA through a standard deltopectoral approach Postoperative rehabilitation will include routine protocols including sling protection for 6 weeks and the following progressive exercises sling pendulum active-assisted range of motion active range of motion passive range of motion and shoulder girdle strengthening Patients randomized to the ultrasound guided ISB group will receive brachial plexus blockade with 10 ml of 05 ropivacaine using a high frequency linear array transducer Sonosite Edge II FUJIFILM Sonsonite Inc Bothell WA USA Patients randomized to the high-volume LIA group will receive 100 mL of 09 normal saline 57ml 05 ropivacaine 40 ml 10 mg morphine 10 mgml 01 mg of epinephrine 01 mgml and 30 mg of ketorolac 30 mgml divided equally into a 20 ml five-zone field infiltration into the suprascapular notchposterior capsule suprascapular and axillary nerves coracobrachialis muscle anterior deltoid muscle superior pectoralis major muscle and skin incision at the conclusion of the procedure by the treating surgeon Patients will be discharged with a standard prescription of multimodal analgesics including acetaminophen ibuprofen sustained release morphine and short acting opioid
In this case because the LIA option is likely associated with lesser cost and lower risk of adverse events non-inferior effectiveness for pain control would provide sufficient and clear evidence that the LIA is the preferred choice The trial will follow CONSORT reporting guidelines All measures will be administered though our Methods Centre web-based data collection and will be completed in clinic under the direction of a study coordinator If a patient misses a follow-up the web-based system will allow us to capture the outcome measures remotely While investigators have selected multiple secondary outcome measures they reflect important secondary dimensions and are measured with well-validated short forms that have low response burden Potential mediators Sex age gender-related pain expectations occupation and comorbid health status will be recorded as potential covariates Sample size estimation The criteria for sample size requirements for noninferiority trials is based on the smallest difference that is considered clinically relevant and the standard deviation expected from the sample n80 participants n40 per group is a conservative estimate based on the ability to detect a moderate effect between study groups for a mean between-groups difference in the primary outcome
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