Improving Sleep Quality After Total Joint Arthroplasty ( TJA)

Stanford University

Status and phase: Withdrawn; Early Phase 1

Conditions: Pain After TJA

Treatments: Drug: Placebo Oral Tablet; Drug: Melatonin 5 mg; Drug: Magnesium 500Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03879707

49586

Details and patient eligibility

About

The purpose of this study is the evaluate and improve sleep quality after Total joint replacement.

Full description

Patients in early stage after TKA tend to suffer from sleep problem. Sleep disturbances frequently occur in patients after surgery, and its occurrence is harmful for postoperative recovery. Many factors can affect the quality of sleep after a major surgery including anesthesia-type, narcotic use and discomfort due to pain or restricted leg movements. Pain directly leads to sleep disruption or even deprivation and, in turn, poor-quality sleep aggravates pain sensation. There seems to be a vicious circle: pain - poor-quality sleep - intensified pain - even poorer-quality sleep.

Presumably, if a patient suffers from catastrophizing, depression and anxiety , the result of TKA will be worse due to poor sleep.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria -Adults 18 years and older

Exclusion criteria -

1. No chronic pain
2. Patients underwent revision or bilateral surgery.
3. Patients underwent fracture.
4. Patients suffering from dementia / delirium
5. Patients on narcotics greater than 10mg hydrocodom before surgery
6. Not willing to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

Melatonin and magnesium for 14 days

Treatment:

Drug: Magnesium 500Mg Oral Tablet

Drug: Melatonin 5 mg

Control

Placebo Comparator group

Description:

Placebo for 14 days

Treatment:

Drug: Placebo Oral Tablet