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Interscalene Dynamometer Pilot Study

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ClinicalTrials.gov Identifier: NCT01550952
Recruitment Status : Completed
First Posted : March 12, 2012
Results First Posted : March 31, 2016
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Tracking Information
First Submitted Date March 1, 2012
First Posted Date March 12, 2012
Results First Submitted Date January 29, 2016
Results First Posted Date March 31, 2016
Last Update Posted Date March 31, 2016
Study Start Date December 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2016)
  • Anterior Deltoid Strength [ Time Frame: 2 days postoperatively ]
    Anterior deltoid strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).
  • Hand Grip Strength [ Time Frame: 2 days postoperatively ]
    Hand grip strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).
Original Primary Outcome Measures
 (submitted: March 7, 2012)
  • Anterior Deltoid Strength [ Time Frame: 2 days postoperatively ]
    Anterior deltoid strength as measured by a dynamometer twice daily
  • Hand Grip Strength [ Time Frame: 2 days postoperatively ]
    Hand grip strength as measured by a dynamometer twice daily
Change History Complete list of historical versions of study NCT01550952 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 1, 2016)
  • Number of Participants With Reduced Sensation in a Dermatome [ Time Frame: 2 days postoperatively ]
    Pin-prick sensation assessed.
  • Numeric Rating Scale (NRS) Pain Scores With Movement [ Time Frame: 2 days postoperatively ]
    NRS pain scores (0-10; 0 = no pain, 10 = worst pain possible) assessed.
  • Total Oral Opioid Intake in 48hrs [ Time Frame: 0-48hrs ]
    Opioid Usage
Original Secondary Outcome Measures
 (submitted: March 7, 2012)
  • Sensory Data [ Time Frame: 2 days postoperatively ]
    Pin-prick sensation assessed twice daily
  • NRS Pain [ Time Frame: 2 days postoperatively ]
    NRS Pain assessed twice daily
  • Opioid Usage [ Time Frame: 2 days postoperatively ]
    Opioid Usage (pre-operative, POD1, POD2)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Interscalene Dynamometer Pilot Study
Official Title Interscalene Dynamometer Pilot Study
Brief Summary Total shoulder arthroplasty (shoulder replacement) can cause severe postoperative pain. Commonly, patients receive general anesthesia with interscalene block (injection of local anesthetic or numbing medicine near nerves in the shoulder) during surgery. As a result of the interscalene block, patients often experience sensory and motor blockade. The purpose of this study is to determine the effects of the interscalene block on the anterior deltoid muscle and hand grip strength after total shoulder arthroplasty.
Detailed Description Total shoulder arthroplasty can cause severe postoperative pain. Pain management includes general anesthesia with interscalene block during surgery and intravenous (IV) hydromorphone patient controlled analgesia (PCA) and oral opioid analgesics given after surgery. Side effects, such as motor blockade, may impair participation in physical therapy and diminish patient satisfaction. In order to prepare for a future study that will examine what mixtures of adjuncts/additives will best prevent recovery room pain and minimize motor blockade, the investigators are conducting this pilot study to collect preliminary data on current practice. The investigators believe the current regimen will provide adequate pain relief, but may cause extensive motor blockade and reduce patients' muscle strength after surgery.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients 18-80 years old who are undergoing primary total shoulder arthroplasty.
Condition Total Shoulder Arthroplasty
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 7, 2012)
10
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients scheduled for primary total shoulder arthroplasty
  • Age 18 to 80 years old
  • Planned use of general anesthesia via laryngeal mask airway (LMA) and peripheral nerve block
  • Ability to follow study protocol
  • Patients with American Society of Anesthesiologists (ASA) physical status of I, II or III

Exclusion Criteria:

  • Patients younger than 18 years old and older than 80
  • Patients not intending to receive general anesthesia and peripheral nerve block
  • Allergy or intolerance to one of the study medications
  • Patients with an ASA of IV
  • Hepatic or renal insufficiency
  • Chronic opioid use (taking opioids for longer than 3 months)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01550952
Other Study ID Numbers 2011-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hospital for Special Surgery, New York
Study Sponsor Hospital for Special Surgery, New York
Collaborators Not Provided
Investigators
Principal Investigator: Jacques T YaDeau, MD, PhD Hospital for Special Surgery, New York
PRS Account Hospital for Special Surgery, New York
Verification Date September 2012