Interscalene Dynamometer Pilot Study

NCT ID: NCT01550952

Last Updated: 2016-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-02-29

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.

Conditions

Total Shoulder Arthroplasty

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques T YaDeau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Other Identifiers

2011-002

Identifier Type: -

Identifier Source: org_study_id