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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior Deltoid Strength	Anterior deltoid strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).	2 days postoperatively
Hand Grip Strength	Hand grip strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).	2 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Reduced Sensation in a Dermatome	Pin-prick sensation assessed.	2 days postoperatively
Numeric Rating Scale (NRS) Pain Scores With Movement	NRS pain scores (0-10; 0 = no pain, 10 = worst pain possible) assessed.	2 days postoperatively
Total Oral Opioid Intake in 48hrs	Opioid Usage	0-48hrs

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 7, 2012
• First Posted (Estimate): March 12, 2012

Study Record Updates

• Last Update Posted (Estimate): March 31, 2016
• Last Update Submitted That Met QC Criteria: March 1, 2016
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 2011-002