Interscalene Dynamometer Pilot Study

Completed

• Conditions: Total Shoulder Arthroplasty

• Registration Number: NCT01550952
• Lead Sponsor: Hospital for Special Surgery, New York

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 Timeline

• Study Start: 2011-12
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-12
• Status Verified: 2012-09
• Results First Submitted: 2016-01-29
• Results First Submitted QC: 2016-03-01
• Last Update Submitted: 2016-03-01
• Results First Posted: 2016-03-31
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anterior Deltoid Strength	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States