Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05908851 |
Other study ID # |
120986 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 1, 2023 |
Est. completion date |
November 1, 2025 |
Study information
Verified date |
October 2023 |
Source |
Lawson Health Research Institute |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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 (n=80) will be
randomized preoperatively into either 1) the ultrasound guided ISB group (n=40) or 2) the
high-volume LIA group (n=40). 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 0.5% 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 0.9% normal saline (57ml), 0.5% ropivacaine (40 ml), 10 mg morphine
(10 mg/ml), 0.1 mg of epinephrine (0.1 mg/ml), and 30 mg of ketorolac (30 mg/ml) divided
equally into a 20 ml five-zone field infiltration into the suprascapular notch/posterior
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. n=80 participants (n=40 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 .