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Completed

NCT Number: NCT03427775

Multimodal Analgesia After Shoulder Arthroscopy

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.

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Key information

Conditions

Analgesia Agnosia Arthroscopy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Shoulder Joint Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. amount of opioids

    Time frame: 24, 48 and 72 hours after surgery

    amount of opioids used converted to mg equivalent of oxycodone

  3. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Assessment of Patient Outcomes After Shoulder Surgery After Implementation of a Multimodal Perioperative Management Protocol

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Feb 9, 2018
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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