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Perioperative Pain Management for Total Shoulder Arthroplasty: A Pilot Non-Inferiority Trial

Primary Purpose

Shoulder Arthritis, Anesthesia, Local, Local Infiltration

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
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)
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients undergoing total shoulder arthroplasty for: Osteoarthritis Rheumatoid arthritis Rotator cuff arthropathy Acute fracture Fracture sequelae. Exclusion Criteria: Patients with known allergy to study medications Patients with obstructive sleep apnea Prior TSA patients previously on chronic narcotic medication patients who are unable to read English patients not able/willing to follow up for the study period of 12 months.

Sites / Locations

  • St. Josephs Healthcare London

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Regional Brachial Plexus Blockade

Local Infiltration Anesthesia

Arm Description

Ultrasound guided brachial plexus blocade with 10 ml of 0.5% ropivacaine using a high frequency linear array transducer.

High volume local infiltration anesthesia with 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.

Outcomes

Primary Outcome Measures

Pain VAS
Pain visual analogue scale - 10 point scale: 0 = no pain, 10 = worst pain imaginable.

Secondary Outcome Measures

ASES Shoulder Score
ASES - Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
EQ5D
Patient Rated general health measure - 100 point scale: 0 = poor health, 100 = excellent health.
Shoulder Pain and Disability Index (SPADI)
Patient Rated Outcome: 0 - 130 rating scale - 0 = low pain and disability, 130 = high pain and disability.
Quick Disabilities of the Arm Shoulder and Hand: Q-DASH
Patient Rated Outcome: 100 point scale: 0 = disability, 100 = no disability
Western Ontario Osteoarthritis Shoulder Score (WOOS)
Patient Rated Outcome - 1900 point scale: 0 = excellent function, 1900 = poor function.
Constant Score
Patient Rated Outcome: 0 - 100 point rating scale: 0 = poor function, 100 = normal function
Single Assessment Numeric Evaluation: SANE Score
Patient Rated Outcome - 100 point rating scale: 0 = poor function, 100 = perfect function
Analgesia Diary
record of analgesics used

Full Information

First Posted
April 25, 2023
Last Updated
October 3, 2023
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05908851
Brief Title
Perioperative Pain Management for Total Shoulder Arthroplasty: A Pilot Non-Inferiority Trial
Official Title
Perioperative Pain Management for Total Shoulder Arthroplasty: A Pilot Non-Inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 (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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Arthritis, Anesthesia, Local, Local Infiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regional Brachial Plexus Blockade
Arm Type
No Intervention
Arm Description
Ultrasound guided brachial plexus blocade with 10 ml of 0.5% ropivacaine using a high frequency linear array transducer.
Arm Title
Local Infiltration Anesthesia
Arm Type
Experimental
Arm Description
High volume local infiltration anesthesia with 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.
Intervention Type
Drug
Intervention Name(s)
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)
Other Intervention Name(s)
High volume local infiltration anesthesia
Intervention Description
Ultrasound guided brachial plexus blockade
Primary Outcome Measure Information:
Title
Pain VAS
Description
Pain visual analogue scale - 10 point scale: 0 = no pain, 10 = worst pain imaginable.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
ASES Shoulder Score
Description
ASES - Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Time Frame
12 months
Title
EQ5D
Description
Patient Rated general health measure - 100 point scale: 0 = poor health, 100 = excellent health.
Time Frame
12 months
Title
Shoulder Pain and Disability Index (SPADI)
Description
Patient Rated Outcome: 0 - 130 rating scale - 0 = low pain and disability, 130 = high pain and disability.
Time Frame
12 months
Title
Quick Disabilities of the Arm Shoulder and Hand: Q-DASH
Description
Patient Rated Outcome: 100 point scale: 0 = disability, 100 = no disability
Time Frame
12 months
Title
Western Ontario Osteoarthritis Shoulder Score (WOOS)
Description
Patient Rated Outcome - 1900 point scale: 0 = excellent function, 1900 = poor function.
Time Frame
12 months
Title
Constant Score
Description
Patient Rated Outcome: 0 - 100 point rating scale: 0 = poor function, 100 = normal function
Time Frame
12 months
Title
Single Assessment Numeric Evaluation: SANE Score
Description
Patient Rated Outcome - 100 point rating scale: 0 = poor function, 100 = perfect function
Time Frame
12 months
Title
Analgesia Diary
Description
record of analgesics used
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing total shoulder arthroplasty for: Osteoarthritis Rheumatoid arthritis Rotator cuff arthropathy Acute fracture Fracture sequelae. Exclusion Criteria: Patients with known allergy to study medications Patients with obstructive sleep apnea Prior TSA patients previously on chronic narcotic medication patients who are unable to read English patients not able/willing to follow up for the study period of 12 months.
Facility Information:
Facility Name
St. Josephs Healthcare London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A4V2
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth J Faber, MD
Phone
5196466312
Email
ken.faber@sjhc.london.on.ca
First Name & Middle Initial & Last Name & Degree
Kristen Barton, MD
Email
kbarto@uwo.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Perioperative Pain Management for Total Shoulder Arthroplasty: A Pilot Non-Inferiority Trial

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