Phase 4 N=80 Randomized Double-blind Treatment

Analgesia After Total Shoulder Arthroplasty

Total Shoulder Arthroplasty

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View on ClinicalTrials.gov: NCT01782872 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2016

Primary outcome: Primary: Numeric Rating Scale (NRS) Pain Score With Movement — 4.5; 3.4; 4.2; 4.9 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Interscalene Block (ISB) - 0.375% Ropivacaine + additives (Procedure); Interscalene Block (ISB) - 0.2% Ropivacaine + additives (Procedure); Interscalene Block (ISB) - 0.1% Ropivacaine + additives (Procedure); Interscalene Block (ISB) - Systemic Control (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hospital for Special Surgery, New York
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Numeric Rating Scale (NRS) Pain Score With Movement	4.5; 3.4; 4.2; 4.9	—
SECONDARY Duration of Analgesia From Interscalene Nerve Block	21.3; 16.8; 18.2; 16.4	—
SECONDARY Numeric Rating Scale (NRS) Pain Scores at Rest	3.0; 3.2; 3.0; 4.9	—
SECONDARY Middle Deltoid	2.8; 1.5; 2.2; 1.8	—

Summary

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01782872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.