Multimodal Analgesia After Shoulder Arthroscopy

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427775
• Other study ID #: 818312
• Status: Completed
• Start date: July 2013
• Est. completion date: July 2017

Study information

• Verified date: July 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: July 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Arthroscopy
• Shoulder Joint

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	quality of pain management	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	24 and 48 hours
Secondary	amount of opioids	amount of opioids used converted to mg equivalent of oxycodone	24, 48 and 72 hours after surgery
Secondary	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	at 48 hours and 72 hours