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Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair

Primary Purpose

Sleep Disturbance

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
melatonin
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who undergo primary ARCR
  • Patient willing and able to complete postoperative surveys

Exclusion Criteria:

  • Daily melatonin use for > 1 week during the last 3 months
  • Irreparable tears
  • Revision rotator cuff repairs
  • Severe glenohumeral arthritis
  • Concurrent adhesive capsulitis
  • Age less than 18
  • Pregnancy
  • History of substance abuse (drug or alcohol)
  • Workman's comp patient or patient has current litigation pending
  • Allergy to melatonin
  • History of delirium/psychiatric/depression/ on antidepressants
  • History of insomnia/ on sleep aid medication
  • Use of prescription sedatives
  • use of Zelboraf (vemurafenib)
  • Use of all blood thinning medications besides aspirin (warfarin, plavix, lovenox, etc.)
  • Sleep apnea

Sites / Locations

  • Rothman Orthopaedics at Egg Harbor Township

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Melatonin supplementation

No supplementation

Arm Description

5mg melatonin tablets to be taken for 6 weeks

Outcomes

Primary Outcome Measures

Pittsburg Sleep Quality Index (PSQI)
PSQI is a validated outcome measure for sleep quality

Secondary Outcome Measures

Full Information

First Posted
February 18, 2020
Last Updated
February 18, 2020
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT04278677
Brief Title
Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair
Official Title
Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to investigate if oral melatonin reduces postoperative sleep 18 disturbances and narcotics use. We will enroll patients undergoing primary arthroscopic rotator 19 cuff repair (ARCR) at the Rothman Institute.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a provider-crossover study design.
Masking
Participant
Masking Description
This is a provider-crossover study design: subjects will receive treatment according to their provider's standard of care
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Melatonin supplementation
Arm Type
Active Comparator
Arm Description
5mg melatonin tablets to be taken for 6 weeks
Arm Title
No supplementation
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
melatonin
Intervention Description
Melatonin capsules to be taken for 6 weeks
Primary Outcome Measure Information:
Title
Pittsburg Sleep Quality Index (PSQI)
Description
PSQI is a validated outcome measure for sleep quality
Time Frame
6 weeks post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who undergo primary ARCR Patient willing and able to complete postoperative surveys Exclusion Criteria: Daily melatonin use for > 1 week during the last 3 months Irreparable tears Revision rotator cuff repairs Severe glenohumeral arthritis Concurrent adhesive capsulitis Age less than 18 Pregnancy History of substance abuse (drug or alcohol) Workman's comp patient or patient has current litigation pending Allergy to melatonin History of delirium/psychiatric/depression/ on antidepressants History of insomnia/ on sleep aid medication Use of prescription sedatives use of Zelboraf (vemurafenib) Use of all blood thinning medications besides aspirin (warfarin, plavix, lovenox, etc.) Sleep apnea
Facility Information:
Facility Name
Rothman Orthopaedics at Egg Harbor Township
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States

12. IPD Sharing Statement

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Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair

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