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Completed

NCT Number: NCT01550952

Interscalene Dynamometer Pilot Study

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Primary outcomes

  1. 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%).

  2. 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%).

Secondary outcomes

  1. Number of Participants With Reduced Sensation in a Dermatome

    Time frame: 2 days postoperatively

    Pin-prick sensation assessed.

  2. 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.

  3. Total Oral Opioid Intake in 48hrs

    Time frame: 0-48hrs

    Opioid Usage

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 12, 2012
Registry last updated
Mar 31, 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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