Analgesia After Total Shoulder Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Total Shoulder Arthroplasty
• Intervention / Treatment: Procedure: 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

Detailed Description

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
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interscalene Block (ISB) - 0.375% Ropivacaine + additives	Procedure: 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
Active Comparator: Interscalene Block (ISB) - 0.2% Ropivacaine + additives	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
Active Comparator: Interscalene Block (ISB) - 0.1% Ropivacaine + additives	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
Active Comparator: Interscalene Block (ISB) - Systemic Control	Procedure: Interscalene Block (ISB) - Systemic Control; Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	24 hours after the interscalene block is given

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Analgesia From Interscalene Nerve Block	Median time until a patient needed to take opioid pain medication	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	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	24 hours after surgery

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: September 24, 2012
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimate): February 4, 2013

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: April 12, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2012-014