Multimodal Sleep Pathway for Shoulder Arthroplasty
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|ClinicalTrials.gov Identifier: NCT03269760|
Recruitment Status : Completed
First Posted : September 1, 2017
Last Update Posted : May 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disturbance Shoulder Arthritis Arthroplasty Complications Perioperative/Postoperative Complications||Drug: Zolpidem||Phase 1|
Shoulder pain at night is a common symptom of shoulder arthritis and contributes to sleep disturbances. Many patients also have difficulty sleeping after shoulder surgery due to the constraints of sling immobilization. While in the hospital, sleep is also disrupted due to pain, nursing staff, other patients, and bathroom use. While poor sleep may appear trivial, sleep deprivation in animal models has identified significant adverse effects on bone metabolism, bone mass, and recovery from post surgical pain.
Recent evidence has shown that non-pharmacological sleep interventions that improve sleep hygiene and duration can optimize athletic peak performance, fatigue, and recovery. Furthermore, pharmacological sleep aid use with zolpidem in orthopaedic postoperative patients has suggested safe administration, improved pain control, reduced pain medication use, and higher patient satisfaction in the settings of total knee and hip arthroplasty, rotator cuff repairs, and ACL reconstruction.
The purpose of the study is to investigate the efficacy of sleep medicine in the recovery of orthopaedic shoulder arthroplasty patients. The investigators hypothesize that a multimodal sleep pathway including non-pharmacological sleep hygiene interventions and the use of zolpidem can improve patient sleep, pain control, and subsequent recovery after undergoing total shoulder arthroplasty.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Advancing the Multimodal Pathway: Investigating the Use of Sleep and Zolpidem in the Recovery After Shoulder Arthroplasty|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||February 1, 2020|
|Actual Study Completion Date :||February 1, 2020|
No Intervention: Control
Current practice of postoperative care without sleep medicine measures
Experimental: Interventional Sleep Medicine
Use of a multimodal sleep pathway including non-pharmacological sleep hygiene interventions and the use of zolpidem to improve patient sleep, pain control, and subsequent recovery after undergoing total shoulder arthroplasty.
Addition of both non-pharmacologic nursing directed sleeping hygiene practices with pharmacologic zolpidem to improve sleep latency
Other Name: Nursing sleep medicine protocol
- Lead's Sleep scale [ Time Frame: postoperative day 1 ]Patient reported outcome
- Sleep journals [ Time Frame: postoperative day 1-7 ]patient reported outcome
- Pain scores [ Time Frame: postoperative day 1 ]]pain scores
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269760
|United States, California|
|San Francisco, California, United States, 94143|