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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01550952
Other study ID # 2011-002
Secondary ID
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


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
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