Clinical trial NCT01550952: Interscalene Dynamometer Pilot Study
Official title: Interscalene Dynamometer Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Shoulder Arthroplasty
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2012-03-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18-80 years old who are undergoing primary total shoulder arthroplasty.

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.

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)

Primary outcomes:
measure: Anterior Deltoid Strength
timeFrame: 2 days postoperatively
measure: Hand Grip Strength
timeFrame: 2 days postoperatively
Secondary outcomes:
measure: Number of Participants With Reduced Sensation in a Dermatome
timeFrame: 2 days postoperatively
measure: Numeric Rating Scale (NRS) Pain Scores With Movement
timeFrame: 2 days postoperatively
measure: Total Oral Opioid Intake in 48hrs
timeFrame: 0-48hrs
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jacques T YaDeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: