AnalgesiaNCT03427775
Multimodal Analgesia After Shoulder Arthroscopy
An observational study of Analgesia and Arthroscopy, run by University of Pennsylvania.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia, Arthroscopy, Shoulder Joint
- What is being tested?
- multimodal perioperative pain protocol (MP3)
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients scheduled for shoulder arthroscopy
Who may be able to join
- Adult patients
- Age 18-80
- Speaks and understands the English language
- Have a phone number
- Scheduled for shoulder arthroscopy
Who cannot join
- Inability to read or speak English
- Individuals outside of age range
- Pregnant women
- Persons under the jurisdiction of the Department of Corrections
About this study
Official title: Assessment of Patient Outcomes After Shoulder Surgery After Implementation of a Multimodal Perioperative Management Protocol
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.
Read the 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.
- Conditions
- Analgesia, Arthroscopy, Shoulder Joint
- Being tested
- multimodal perioperative pain protocol (MP3)
- Keywords
- multimodal analgesia, quality of recovery, quality of pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| pre-MP3 | before implementation of the multimodal analgesia protocol | |
| post-MP3 | after implementation of the multimodal analgesia protocol Receives: Combination Product: multimodal perioperative pain protocol (MP3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (3)
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
Measured: 24 and 48 hours
amount of opioids
amount of opioids used converted to mg equivalent of oxycodone
Measured: 24, 48 and 72 hours after surgery
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
Measured: at 48 hours and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study startJul 2013
- Primary completionApr 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Elkassabany, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427775
- Sponsor's protocol ID
- 818312
- Status last verified
- Jul 2019
- First submitted
- 29 Jan 2018
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Elkassabany NM, Wang A, Ochroch J, Mattera M, Liu J, Kuntz A. Improved Quality of Recovery from Ambulatory Shoulder Surgery After Implementation of a Multimodal Perioperative Pain Management Protocol. Pain Med. 2019 May 1;20(5):1012-1019. doi: 10.1093/pm/pny152.
PubMed 30113685
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient Outcomes After Shoulder Surgery After Implementation of a Multimodal Perioperative Management Protocol
- ClinicalTrials.gov ID
- NCT03427775
- Acronym / sponsor ID
- 818312
- Conditions
- Analgesia, Arthroscopy, Shoulder Joint
- Keywords
- multimodal analgesia, quality of recovery, quality of pain management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-MP3 | – | –before implementation of the multimodal analgesia protocol |
| post-MP3 | – | Combination Product: multimodal perioperative pain protocol (MP3)after implementation of the multimodal analgesia protocol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for shoulder arthroscopy
Key inclusion criteria (5 listed)
- Adult patients
- Age 18-80
- Speaks and understands the English language
- Have a phone number
- Scheduled for shoulder arthroscopy
Key exclusion criteria (4 listed)
- Inability to read or speak English
- Individuals outside of age range
- Pregnant women
- Persons under the jurisdiction of the Department of Corrections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Combination product | post-MP3 |
Primary outcome
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
3 secondary outcomes
quality of pain management
Time frame: 24 and 48 hours
amount of opioids
Time frame: 24, 48 and 72 hours after surgery
QOR-9
Time frame: at 48 hours and 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Derived from this study: PubMed 30113685Elkassabany NM, Wang A, Ochroch J, Mattera M, Liu J, Kuntz A. Improved Quality of Recovery from Ambulatory Shoulder Surgery After Implementation of a Multimodal Perioperative Pain Management Protocol. Pain Med. 2019 May 1;20(5):1012-1019. doi: 10.1093/pm/pny152.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesia and Arthroscopy, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QOR-9 (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03427775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019; AzTrials last refreshed its copy on 3 Nov 2026.