Shoulder PainPhase 3NCT04725357
Does Meloxicam Provide as Much Pain Relief as Opioids After Shoulder Surgery?
A Phase 3 study testing Meloxicam 15 mg, Preoperative Interscalene Nerve Block and arthroscopic labral repair in people with Shoulder Pain, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The opioid epidemic continues to be a major concern, with orthopedic surgeons being among the top prescribers of opioids. Studies evaluating these practices found that opioids are overprescribed, even for common procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Meloxicam 15 mg, Preoperative Interscalene Nerve Block and arthroscopic labral repair
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 25 Jan 2022
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Scheduled for arthroscopic labrum repair of the shoulder
Who cannot join
- History of opioid, acetaminophen, NSAID or local anesthetic allergy or intolerance, or contraindications to these medications.
- Currently on long-term preoperative narcotics
- Scheduled for revision arthroscopic repairs of the shoulder
- Unable/unwilling to consent for enrollment
- Unable to complete postoperative surveys
- History of chronic pain syndromes (fibromyalgia, chronic diffuse MSK pain, etc)
Show all 9Show fewer
- Patients under the age of 18
- Pregnant or breastfeeding women
- Scheduled for concurrent procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Randomized Comparison of Meloxicam to Opioids Following Arthroscopic Labrum Repairs of the Shoulder
The opioid epidemic continues to be a major concern, with orthopedic surgeons being among the top prescribers of opioids. Studies evaluating these practices found that opioids are overprescribed, even for common procedures. Patients undergoing arthroscopic labrum repair of the shoulder were found to have an average of 20 pills left over after surgery. Many strategies have been developed to tackle overprescribing and have found success, including no opioid protocols for carpal tunnel release. The purpose of this study is to examine if meloxicam alone provides similar patient reported outcomes to opioids following arthroscopic labrum repair of the shoulder.
- Conditions
- Shoulder Pain
- Being tested
- Meloxicam 15 mg, Preoperative Interscalene Nerve Block, arthroscopic labral repair
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meloxicam 15 mgDrug
Participants will receive a prescription of 20 pills of 15 mg Meloxicam after surgery
Preoperative Interscalene Nerve BlockProcedure or surgery
Preoperatively participants will standardly receive an interscalene nerve block
arthroscopic labral repairProcedure or surgery
participant will have their standard surgical procedure done
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Labral Repair + postoperative Meloxicam | Experimental | After surgery participants will receive a prescription of 20 pills of 15 mg Meloxicam Receives: Drug: Meloxicam 15 mg; Procedure: Preoperative Interscalene Nerve Block; Procedure: arthroscopic labral repair |
| Arthroscopic Labral Repair without Meloxicam | Active comparator | After surgery participants will receive a prescription of 20 pills of 5/300 mg vicodin (hydrocodone/acetaminophen) Receives: Procedure: Preoperative Interscalene Nerve Block; Procedure: arthroscopic labral repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Analgesic use
Participants will be given a survey asking about number of pills taken
Measured: 14 days
Postoperative Pain Control
Measured by the Numerical Rating Scale (NRS) pain score daily after surgery
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start25 Jan 2021 (estimated)
- Primary completion25 Jan 2022 (estimated)
- Study completion25 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725357
- Sponsor's protocol ID
- JHOR20D.1216
- Status last verified
- Jan 2021
- First submitted
- 18 Jan 2021
- Last updated
- 26 Jan 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Meloxicam to Opioids Following Arthroscopic Labrum Repairs of the Shoulder
- ClinicalTrials.gov ID
- NCT04725357
- Acronym / sponsor ID
- JHOR20D.1216
- Conditions
- Shoulder Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 25 Jan 2021 (estimated)
- Primary completion
- 25 Jan 2022 (estimated)
- Study completion
- 25 Jan 2022 (estimated)
- First posted
- 26 Jan 2021 (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.
The opioid epidemic continues to be a major concern, with orthopedic surgeons being among the top prescribers of opioids. Studies evaluating these practices found that opioids are overprescribed, even for common procedures. Patients undergoing arthroscopic labrum repair of the shoulder were found to have an average of 20 pills left over after surgery. Many strategies have been developed to tackle overprescribing and have found success, including no opioid protocols for carpal tunnel release. The purpose of this study is to examine if meloxicam alone provides similar patient reported outcomes to opioids following arthroscopic labrum repair of the shoulder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Labral Repair + postoperative Meloxicam | Experimental | Drug: Meloxicam 15 mg, Procedure: Preoperative Interscalene Nerve Block, Procedure: arthroscopic labral repairAfter surgery participants will receive a prescription of 20 pills of 15 mg Meloxicam |
| Arthroscopic Labral Repair without Meloxicam | Active comparator | Procedure: Preoperative Interscalene Nerve Block, Procedure: arthroscopic labral repairAfter surgery participants will receive a prescription of 20 pills of 5/300 mg vicodin (hydrocodone/acetaminophen) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18
- Scheduled for arthroscopic labrum repair of the shoulder
Key exclusion criteria (9 listed)
- History of opioid, acetaminophen, NSAID or local anesthetic allergy or intolerance, or contraindications to these medications.
- Currently on long-term preoperative narcotics
- Scheduled for revision arthroscopic repairs of the shoulder
- Unable/unwilling to consent for enrollment
- Unable to complete postoperative surveys
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 |
|---|---|---|
| Meloxicam 15 mgParticipants will receive a prescription of 20 pills of 15 mg Meloxicam after surgery | Drug | Arthroscopic Labral Repair + postoperative Meloxicam |
| Preoperative Interscalene Nerve BlockPreoperatively participants will standardly receive an interscalene nerve block | Procedure or surgery | Arthroscopic Labral Repair + postoperative Meloxicam, Arthroscopic Labral Repair without Meloxicam |
| arthroscopic labral repairparticipant will have their standard surgical procedure done | Procedure or surgery | Arthroscopic Labral Repair + postoperative Meloxicam, Arthroscopic Labral Repair without Meloxicam |
Primary outcome
Total Analgesic use
Time frame: 14 days
Participants will be given a survey asking about number of pills taken
Postoperative Pain Control
Time frame: 14 days
Measured by the Numerical Rating Scale (NRS) pain score daily after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
Related trials for Shoulder Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
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?
A Phase 3 study testing Meloxicam 15 mg, Preoperative Interscalene Nerve Block and arthroscopic labral repair in people with Shoulder Pain, run by Rothman Institute Orthopaedics at 1 site in United States.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Jan 2021. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Total Analgesic use (time frame: 14 days). The study lists 2 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 26 Jan 2021.