Analgesia After Total Shoulder Arthroplasty

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Total Shoulder Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Interscalene Block (ISB) - 0.375% Ropivacaine + additives

Group Type ACTIVE_COMPARATOR

Interscalene Block (ISB) - 0.375% Ropivacaine + additives

Intervention Type PROCEDURE

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 + additives

Group Type ACTIVE_COMPARATOR

Interscalene Block (ISB) - 0.2% Ropivacaine + additives

Intervention Type PROCEDURE

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 + additives

Group Type ACTIVE_COMPARATOR

Interscalene Block (ISB) - 0.1% Ropivacaine + additives

Intervention Type PROCEDURE

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

Interscalene Block (ISB) - Systemic Control

Group Type ACTIVE_COMPARATOR

Interscalene Block (ISB) - Systemic Control

Intervention Type PROCEDURE

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

Interventions

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Interscalene Block (ISB) - 0.375% Ropivacaine + additives

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

Intervention Type PROCEDURE

Interscalene Block (ISB) - 0.2% Ropivacaine + additives

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

Intervention Type PROCEDURE

Interscalene Block (ISB) - 0.1% Ropivacaine + additives

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

Intervention Type PROCEDURE

Interscalene Block (ISB) - Systemic Control

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No