Multimodal Analgesia After Shoulder Arthroscopy

ID: NCT03427775
Status: Completed
Phase: N/A
Start Date: July 01, 2013
First Submitted: January 29, 2018
Last Updated: February 02, 2018
Results: N/A
Sponsors & Collaborators: University of Pennsylvania
Location: N/A
Conditions: Analgesia , Arthroscopy, Shoulder Joint
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Study Description

Brief Summary

Pain management after shoulder surgery remains to be a major challenge. Reliance on a single agent (most commonly opioids) results in increased incidence of side effects. Multimodal pain management refers to the use of multiple drugs that target different components of pain pathway.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.

Detailed Description

Condition or disease Intervention/treatment Phase

Analgesia , Arthroscopy, Shoulder Joint

Combination Product: multimodal perioperative pain protocol (MP3)
Other Names
N/A

Tracking Information

First Submitted DateJanuary 29, 2018
Last Update Posted DateFebruary 02, 2018
Actual Start DateJuly 01, 2013
Actual Completion DateJuly 01, 2017
Actual Primary Completion DateApril 01, 2016
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • QOR-9 [Time Frame: 24 hours]

    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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • quality of pain management [Time Frame: 24 and 48 hours]

    quality of pain management was measured using the revised american pain society patient oriented outcome questionnaire (APS-POQ-R). The questionnaire measures quality of pain management in 5 domains: 1- pain intensity 2- pain interference with activity and sleep 3- emotional side effects of uncontrolled pain ( affective scale). 4- patient perception of their pain management 5-side effects of pain treatment some questions answers are on a scale from 0-10. Ten is the maximum score and zero is the minimum score. other questions are listed as percentage with increments of 10% at a time (0%,10%, 20%, 30%..etc). each item/question is reported individually

  • amount of opioids [Time Frame: 24, 48 and 72 hours after surgery]

    amount of opioids used converted to mg equivalent of oxycodone

  • QOR-9 [Time Frame: at 48 hours and 72 hours]

    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

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleMultimodal Analgesia After Shoulder Arthroscopy
Official TitleAssessment of Patient Outcomes After Shoulder Surgery After Implementation of a Multimodal Perioperative Management Protocol
Brief Summary

Pain management after shoulder surgery remains to be a major challenge. Reliance on a single agent (most commonly opioids) results in increased incidence of side effects. Multimodal pain management refers to the use of multiple drugs that target different components of pain pathway.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.

Detailed Description

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
252
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Analgesia , Arthroscopy, Shoulder Joint
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study Populationpatients scheduled for shoulder arthroscopy
Intervention
Combination Product: multimodal perioperative pain protocol (MP3)

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

Other Names
Study Groups/Cohorts
pre-MP3
before implementation of the multimodal analgesia protocol

post-MP3
after implementation of the multimodal analgesia protocol

Study Arms
post-MP3
after implementation of the multimodal analgesia protocol
Combination Product : multimodal perioperative pain protocol (MP3)
administration of gabapentionoid, acetaminophen, non steroidal anti-inflammatory drugs around the clock in addition to the peripheral nerve block offered before surgery

Arm Intervention/Treatment
post-MP3
after implementation of the multimodal analgesia protocol
Combination Product : multimodal perioperative pain protocol (MP3)

Recruitment Information

Recruitment Status:Completed
Enrollment252
Completion DateJuly 01, 2017
Eligibility Criteria: Inclusion Criteria:
- Adult patients
- Age 18-80
- Speaks and understands the English language
- Have a phone number
- Scheduled for shoulder arthroscopy

Exclusion Criteria:
- Inability to read or speak English
- Individuals outside of age range
- Pregnant women
- Persons under the jurisdiction of the Department of Corrections
GenderAll
Age18 Years to 80 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Not Available

Administrative Information

NCT Number:NCT03427775
Other Study ID Numbers
818312
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyNabil Elkassabany, University of Pennsylvania
Study Sponsor
University of Pennsylvania
Collaborators
Not Available
Investigators
Not Available