Multimodal Analgesia After Shoulder Arthroscopy

Completed

• Conditions: Arthroscopy; Analgesia; Shoulder Joint
• Interventions: Combination Product: multimodal perioperative pain protocol (MP3)

• Registration Number: NCT03427775
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2016-04
• Study Completion: 2017-07
• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-09
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
post-MP3	multimodal perioperative pain protocol (MP3)	after implementation of the multimodal analgesia protocol

Primary Outcome Measures

Name	Time	Method
QOR-9	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

Secondary Outcome Measures

Name	Time	Method
quality of pain management	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
QOR-9	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
amount of opioids	24, 48 and 72 hours after surgery	amount of opioids used converted to mg equivalent of oxycodone