Multimodal Analgesia After Shoulder Arthroscopy

Study Description

Brief Summary

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 Date	January 29, 2018
Last Update Posted Date	February 02, 2018
Actual Start Date	July 01, 2013
Actual Completion Date	July 01, 2017
Actual Primary Completion Date	April 01, 2016
Results First Submitted Date	N/A
Received Results Disposit Date	N/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

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

Study Design

Brief Title	Multimodal Analgesia After Shoulder Arthroscopy
Official Title	Assessment 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 Type	Observational
Study Phase	N/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 Method	Non-Probability Sample
Study Population	patients 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) administration of gabapentionoid, acetaminophen, non steroidal anti-inflammatory drugs around the clock in addition to the peripheral nerve block offered before surgery

Recruitment Information

Recruitment Status:	Completed
Enrollment	252
Completion Date	July 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
Gender	All
Age	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts	Not Available
Listed Location Countries	Not Available

Administrative Information

NCT Number:	NCT03427775
Other Study ID Numbers	818312
Has Data Monitoring Committee	No
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 Party	Nabil Elkassabany, University of Pennsylvania
Study Sponsor	University of Pennsylvania
Collaborators	Not Available
Investigators	Not Available