NCT04039191

Brief Summary

The purpose the research is to assess whether or not postoperative education and awareness about pain and opioid use through SMS text messages will reduce overall opioid utilization after common outpatient surgeries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

December 9, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

November 2, 2023

Status Verified

November 1, 2023

Enrollment Period

3.6 years

First QC Date

July 29, 2019

Last Update Submit

November 1, 2023

Conditions

Opioid UsePain, Postoperative

Keywords

SMSEducationOpioid UsePainpostoperative

Outcome Measures

Primary Outcomes (1)

  • Number of opioid pills consumed

    Number of opioid pills consumed

    10 days post-op

Secondary Outcomes (1)

  • Post-operative pain scores

    10 days post-op

Study Arms (2)

SMS survey

PLACEBO COMPARATOR

Subject to receive SMS survey.

Behavioral: SMS survey

SMS survey with education

ACTIVE COMPARATOR

Subject to receive SMS survey with education.

Behavioral: SMS education

Interventions

SMS educationBEHAVIORAL

Patients will receive additional educational SMS messages post-operatively

SMS survey with education
SMS surveyBEHAVIORAL

Patients will receive survey questions about post-operative pain and opioid use but no education

SMS survey

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients aged ≥18 who are undergoing outpatient surgery (admission \<23hrs) where opioids are typically prescribed

You may not qualify if:

  • Non-English speaking patients.
  • No access to cellphone.
  • Admission beyond 24 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Yufei Chen, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2019

First Posted

July 31, 2019

Study Start

December 9, 2019

Primary Completion

June 30, 2023

Study Completion

July 30, 2023

Last Updated

November 2, 2023

Record last verified: 2023-11

Locations

US(1)