Interscalene Dynamometer Pilot Study

Total Shoulder Arthroplasty Clinical Trial

Official title:

Interscalene Dynamometer Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550952
• Other study ID #: 2011-002
• Status: Completed
• Phase: N/A
• First received: March 1, 2012
• Last updated: September 24, 2012
• Start date: December 2011
• Est. completion date: February 2012

Study information

• Verified date: September 2012
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Total Shoulder Arthroplasty

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior Deltoid Strength	Anterior deltoid strength as measured by a dynamometer twice daily	2 days postoperatively	No
Primary	Hand Grip Strength	Hand grip strength as measured by a dynamometer twice daily	2 days postoperatively	No
Secondary	Sensory Data	Pin-prick sensation assessed twice daily	2 days postoperatively	No
Secondary	Numeric Rating Scale (NRS) Pain Scores	NRS pain scores (0-10; 0 = no pain, 10 = worst pain possible) assessed twice daily	2 days postoperatively	No
Secondary	Opioid Usage	Opioid Usage (pre-operative, postoperative day [POD] 1, POD2)	2 days postoperatively	No