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Completed

NCT Number: NCT01782872

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interscalene Block (ISB) - 0.375% Ropivacaine + additives

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

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

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

Procedure

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

Primary outcomes

  1. Numeric Rating Scale (NRS) Pain Score With Movement

    Time frame: 24 hours after the interscalene block is given

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

Secondary outcomes

  1. Duration of Analgesia From Interscalene Nerve Block

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

    Median time until a patient needed to take opioid pain medication

  2. Numeric Rating Scale (NRS) Pain Scores at Rest

    Time frame: Preop

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

  3. Middle Deltoid

    Time frame: 24 hours after surgery

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

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2013
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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