Analgesia After Total Shoulder Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01782872
First received: September 24, 2012
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Total Shoulder Arthroplasty
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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesia After Total Shoulder Arthroplasty

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • Numeric Rating Scale (NRS) Pain Score with Movement [ Time Frame: 24 hours after the interscalene block is given ] [ Designated as safety issue: No ]
    Pain with movement at 24 hours from the nerve block (scale of 0-10; 0 = no pain, 10 = worst possible pain)


Secondary Outcome Measures:
  • Duration of Analgesia from Interscalene Nerve Block [ Time Frame: Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM ] [ Designated as safety issue: No ]
    Patients will be asked about the duration of analgesia from an analgesic interscalene block at each visit until the block has resolved

  • Numeric Rating Scale (NRS) Pain Scores at Rest and with Movement [ Time Frame: Day of surgery (preop & 1-2 hours after arrival in the Post Anesthesia Care Unit), postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM ] [ Designated as safety issue: No ]
    Assessment of NRS pain scores (scale of 0-10; 0 = no pain, 10 = worst possible pain) at rest and with movement

  • Middle Deltoid & Hand Grip Strength [ Time Frame: Day of surgery (preop & 1-2 hours after arrival in the Post Anesthesia Care Unit), postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM ] [ Designated as safety issue: No ]
    A physical assessment will be done to determine the strength of the middle deltoid muscle and hand grip in the operative arm using a dynamometer


Enrollment: 80
Study Start Date: October 2012
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782872

Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Jacques T YaDeau, MD, PhD Hospital for Special Surgery, New York
  More Information

No publications provided

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01782872     History of Changes
Other Study ID Numbers: 2012-014
Study First Received: September 24, 2012
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014