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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05908851
• Other study ID #: 120986
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Arthritis
• Local Infiltration
• Shoulder Arthritis

Intervention

Drug:
• 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)
Ultrasound guided brachial plexus blockade

Locations

Country	Name	City	State
Canada	St. Josephs Healthcare London	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain VAS	Pain visual analogue scale - 10 point scale: 0 = no pain, 10 = worst pain imaginable.	12 months
Secondary	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.	12 months
Secondary	EQ5D	Patient Rated general health measure - 100 point scale: 0 = poor health, 100 = excellent health.	12 months
Secondary	Shoulder Pain and Disability Index (SPADI)	Patient Rated Outcome: 0 - 130 rating scale - 0 = low pain and disability, 130 = high pain and disability.	12 months
Secondary	Quick Disabilities of the Arm Shoulder and Hand: Q-DASH	Patient Rated Outcome: 100 point scale: 0 = disability, 100 = no disability	12 months
Secondary	Western Ontario Osteoarthritis Shoulder Score (WOOS)	Patient Rated Outcome - 1900 point scale: 0 = excellent function, 1900 = poor function.	12 months
Secondary	Constant Score	Patient Rated Outcome: 0 - 100 point rating scale: 0 = poor function, 100 = normal function	12 months
Secondary	Single Assessment Numeric Evaluation: SANE Score	Patient Rated Outcome - 100 point rating scale: 0 = poor function, 100 = perfect function	12 months
Secondary	Analgesia Diary	record of analgesics used	3 months