Pain, ShoulderNCT03732456
Post-operative Pain After Shoulder Surgery
An observational study of Pain, Shoulder, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
A prospective observational study conducted at the American University of Beirut Medical center that targets patients undergoing shoulder surgeries. It is conducted to to prospectively collect patient, surgery and anesthesia-related variables and perform correlation studies with postoperative pain severity, patients'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Shoulder
- What is being tested?
- Shoulder surgery and post-op pharmacological treatment
- Type of treatment
- Surgery or procedure
- How many people
- 146 participants
- Where
- 1 siteLebanon
- Study dates
- 19 Jul 2018to 20 Apr 2020
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients older than 18 years of age and admitted to the American University of Beirut Medical Center for any shoulder surgery
Who may be able to join
- All adult patients > 18 years old admitted to the American University of Beirut - Medical Center for any shoulder surgery
Who cannot join
- Patients suffering of opioids addiction (or previous history of addiction) or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of Post-operative Pain in Shoulder Surgery, a Prospective Observational Study
A prospective observational study conducted at the American University of Beirut Medical center that targets patients undergoing shoulder surgeries. It is conducted to to prospectively collect patient, surgery and anesthesia-related variables and perform correlation studies with postoperative pain severity, patients' satisfaction and analgesic consumption following shoulder surgery.
In addition, identifying predictors for postoperative pain will contribute to adjust pain management protocols as per surgical and patients' factors.
- Conditions
- Pain, Shoulder
- Being tested
- Shoulder surgery and post-op pharmacological treatment
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder surgery and post-op pharmacological treatmentProcedure or surgery
Usual care surgery (shoulder arthroscopy) and post-operative pain management protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative change in pain intensity (NRS pain scale)
Asses the change in pain intensity after the surgery using the NRS pain score (0-10)
Measured: 24 hours, 3 days and one week after surgery
Postoperative change in satisfaction with pain management (NRS satisfaction scale)
Asses the change in satisfaction with the pain management protocol using the NRS satisfaction score (0-10)
Measured: 24 hours, 3 days and one week after surgery
Postoperative analgesic consumption
Analgesic consumption over one week after the surgery
Measured: Over one week
Postoperative functional level (QuickDASH questionnaire)
The QuickDASH questionnaire includes questions about the symptoms and ability to do certain activities
Measured: One week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start19 Jul 2018
- Primary completion20 Apr 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ShoulderStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marie Awad, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732456
- Sponsor's protocol ID
- BIO-2018-0083
- Status last verified
- Jun 2020
- First submitted
- 2 Nov 2018
- Last updated
- 12 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Post-operative Pain in Shoulder Surgery, a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03732456
- Acronym / sponsor ID
- BIO-2018-0083
- Conditions
- Pain, Shoulder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 6 Nov 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.
A prospective observational study conducted at the American University of Beirut Medical center that targets patients undergoing shoulder surgeries. It is conducted to to prospectively collect patient, surgery and anesthesia-related variables and perform correlation studies with postoperative pain severity, patients' satisfaction and analgesic consumption following shoulder surgery.
In addition, identifying predictors for postoperative pain will contribute to adjust pain management protocols as per surgical and patients' factors.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients older than 18 years of age and admitted to the American University of Beirut Medical Center for any shoulder surgery
Key inclusion criteria (1 listed)
- All adult patients > 18 years old admitted to the American University of Beirut - Medical Center for any shoulder surgery
Key exclusion criteria (1 listed)
- Patients suffering of opioids addiction (or previous history of addiction) or drug abuse.
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 |
|---|---|---|
| Shoulder surgery and post-op pharmacological treatmentUsual care surgery (shoulder arthroscopy) and post-operative pain management protocol | Procedure or surgery | – |
Primary outcome
Postoperative change in pain intensity (NRS pain scale)
Time frame: 24 hours, 3 days and one week after surgery
Asses the change in pain intensity after the surgery using the NRS pain score (0-10)
Postoperative change in satisfaction with pain management (NRS satisfaction scale)
Time frame: 24 hours, 3 days and one week after surgery
Asses the change in satisfaction with the pain management protocol using the NRS satisfaction score (0-10)
Postoperative analgesic consumption
Time frame: Over one week
Analgesic consumption over one week after the surgery
Postoperative functional level (QuickDASH questionnaire)
Time frame: One week after surgery
The QuickDASH questionnaire includes questions about the symptoms and ability to do certain activities
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 12 Jun 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Shoulder, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 1 inclusion and 1 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 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Postoperative change in pain intensity (NRS pain scale) (time frame: 24 hours, 3 days and one week after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2020.