Interscalene Dynamometer Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01550952
First received: March 1, 2012
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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.


Condition
Total Shoulder Arthroplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Interscalene Dynamometer Pilot Study

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

Primary Outcome Measures:
  • Anterior Deltoid Strength [ Time Frame: 2 days postoperatively ] [ Designated as safety issue: No ]
    Anterior deltoid strength as measured by a dynamometer twice daily

  • Hand Grip Strength [ Time Frame: 2 days postoperatively ] [ Designated as safety issue: No ]
    Hand grip strength as measured by a dynamometer twice daily


Secondary Outcome Measures:
  • Sensory Data [ Time Frame: 2 days postoperatively ] [ Designated as safety issue: No ]
    Pin-prick sensation assessed twice daily

  • Numeric Rating Scale (NRS) Pain Scores [ Time Frame: 2 days postoperatively ] [ Designated as safety issue: No ]
    NRS pain scores (0-10; 0 = no pain, 10 = worst pain possible) assessed twice daily

  • Opioid Usage [ Time Frame: 2 days postoperatively ] [ Designated as safety issue: No ]
    Opioid Usage (pre-operative, postoperative day [POD] 1, POD2)


Enrollment: 10
Study Start Date: December 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients 18-80 years old who are undergoing primary total shoulder arthroplasty.

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)
  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: NCT01550952

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: NCT01550952     History of Changes
Other Study ID Numbers: 2011-002
Study First Received: March 1, 2012
Last Updated: September 24, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014