Analgesia After Total Shoulder Arthroplasty

Hospital for Special Surgery, New York80 enrolled

Overview

The purpose of this study is to determine which medication(s) should be included in the interscalene nerve block (an injection of local anesthetic \[numbing medicine\] near nerves in the shoulder) for patients undergoing total shoulder arthroplasty (shoulder replacement). The ideal nerve block would reduce pain after shoulder surgery without causing a great deal of muscle weakness.

All patients will receive an intravenous pain pump (patient-controlled analgesia) and a nerve block with long-lasting local anesthetic. The three study groups will receive additives (clonidine, dexamethasone, buprenorphine plus local anesthetic) in the nerve block that may reduce postoperative pain. One of the study groups uses the usual concentration of local anesthetic, while the other two study groups use reduced concentrations of local anesthetic. Follow-up with study patients begins on the day of surgery and continues through postoperative day 2. Seen twice daily, patients will be asked about their pain and assessed for sensory function and strength of their shoulder muscle and hand grip.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Total Shoulder Arthroplasty

Interventions

Interscalene Block (ISB) - 0.375% Ropivacaine + additivesPROCEDURE

Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous (IV): saline

Interscalene Block (ISB) - 0.2% Ropivacaine + additivesPROCEDURE

Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline

Interscalene Block (ISB) - 0.1% Ropivacaine + additivesPROCEDURE

Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine \[100 mcg\] + dexamethasone \[4 mg\] + buprenorphine \[150 mcg\]); Intravenous: saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with osteoarthritis * Primary total shoulder arthroplasty * Age 18 to 80 years old * Planned use of general anesthesia * Planned use of a brachial plexus nerve block for postoperative analgesia * Ability to follow study protocol Exclusion Criteria: * Patients younger than 18 years old and older than 80 * Allergy or intolerance to one of the study medications * Patients with an American Society of Anesthesiologists (ASA) physical status of IV * Patients with insulin-dependent diabetes * Patients with hepatic (liver) failure * Patients with chronic renal (kidney) failure * Bradycardia (heart rate \< 50) or hypotension (systolic blood pressure \< 90 mmHg) * Chronic opioid use (taking opioids for longer than 3 months) (or active diagnosis of complex regional pain syndrome \[CRPS\]/reflex sympathetic dystrophy \[RSD\]) * Lack of English fluency

Locations (1)

Hospital for Special Surgery

New York, New York, United States

Outcomes

Primary Outcomes

Numeric Rating Scale (NRS) Pain Score With Movement

Pain with movement at 24 hours from the nerve block (scale of 0-10; 0 = no pain, 10 = worst possible pain)

Time frame: 24 hours after the interscalene block is given

Secondary Outcomes

Duration of Analgesia From Interscalene Nerve Block

Median time until a patient needed to take opioid pain medication

Time frame: Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM

Numeric Rating Scale (NRS) Pain Scores at Rest

Assessment of NRS pain scores (scale of 0-10; 0 = no pain, 10 = worst possible pain) at rest

Time frame: Preop

Middle Deltoid

A physical assessment will be done to determine the strength of the middle deltoid muscle in the operative arm using a dynamometer

Time frame: 24 hours after surgery

Data from ClinicalTrials.gov

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