NCT03427775

Brief Summary

This proposal aims to measure the quality of recovery and quality of pain management after shoulder surgery before and after implementation of a multimodal pain protocol.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

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

Study Start

First participant enrolled

July 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

2.8 years

First QC Date

January 29, 2018

Last Update Submit

July 15, 2019

Conditions

AnalgesiaArthroscopyShoulder Joint

Keywords

multimodal analgesiaquality of recoveryquality of pain management

Outcome Measures

Primary Outcomes (1)

  • QOR-9

    quality of recovery score using the QOR-9 instrument: it is a 9 item questionnaire with each question scoring from 0,1,2 with a total highest possible score of 18

    24 hours

Secondary Outcomes (3)

  • quality of pain management

    24 and 48 hours

  • amount of opioids

    24, 48 and 72 hours after surgery

  • QOR-9

    at 48 hours and 72 hours

Study Arms (2)

pre-MP3

before implementation of the multimodal analgesia protocol

post-MP3

after implementation of the multimodal analgesia protocol

Combination Product: multimodal perioperative pain protocol (MP3)

Interventions

multimodal perioperative pain protocol (MP3)COMBINATION_PRODUCT

administration of gabapentionoid, acetaminophen, non steroidal anti-inflammatory drugs around the clock in addition to the peripheral nerve block offered before surgery

post-MP3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients scheduled for shoulder arthroscopy

You may qualify if:

  • Adult patients
  • Age 18-80
  • Speaks and understands the English language
  • Have a phone number
  • Scheduled for shoulder arthroscopy

You may not qualify if:

  • Inability to read or speak English
  • Individuals outside of age range
  • Pregnant women
  • Persons under the jurisdiction of the Department of Corrections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Elkassabany NM, Wang A, Ochroch J, Mattera M, Liu J, Kuntz A. Improved Quality of Recovery from Ambulatory Shoulder Surgery After Implementation of a Multimodal Perioperative Pain Management Protocol. Pain Med. 2019 May 1;20(5):1012-1019. doi: 10.1093/pm/pny152.

    PMID: 30113685DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 9, 2018

Study Start

July 1, 2013

Primary Completion

April 1, 2016

Study Completion

July 1, 2017

Last Updated

July 18, 2019

Record last verified: 2019-07