Narcotic UsePhase 2/3NCT03825809
Nonopioid Analgesia After Labral Surgery
A Phase 2/3 study testing Celecoxib, Hydrocodone-Acetaminophen and Ketorolac in people with Narcotic Use, run by Henry Ford Health System at 1 site in United States.
Trial summary
This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Narcotic Use
- What is being tested?
- Celecoxib, Hydrocodone-Acetaminophen and Ketorolac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2019to 20 May 2020
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- All adult patients over age 18 and scheduled for a primary or revision labral surgery
Who cannot join
- Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact rotator cuff
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Toufic R Jildeh, MD
About this study
Official title: Traditional vs. Nonopioid Analgesia After Labral Surgery
This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen
Read the detailed description
Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring rotator cuff repair will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty.
Patients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia
Primary endpoints is reduction in pain as measured by VAS and PROMIS. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure.
Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.
- Conditions
- Narcotic Use
- Being tested
- Celecoxib, Hydrocodone-Acetaminophen, Ketorolac, Gabapentin, Acetaminophen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex
Post-Operative Non Opioid Pain Protocol
Hydrocodone-AcetaminophenDrug
Also called Norco
Traditionally used narcotic pain protocol
KetorolacDrug
Also called Toradol
Post-Operative Non Opioid Pain Protocol
GabapentinDrug
Also called Neurontin
Post-Operative Non Opioid Pain Protocol
AcetaminophenDrug
Also called Tylenol
Post-Operative Non Opioid Pain Protocol
DiazepamDrug
Also called Valium
Post-Operative Non Opioid Pain Protocol
| Study group | Role | What they receive |
|---|---|---|
| Post-Operative Non Opioid Pain Protocol | Experimental | Patients will be administered a post-operative non-opioid pain protocol consisting of:
Celecoxib Ketorolac Gabapentin Acetaminophen Diazepam Receives: Drug: Celecoxib; Drug: Ketorolac; Drug: Gabapentin; Drug: Acetaminophen; Drug: Diazepam |
| Post-Operative Traditional Pain Protocol | Active comparator | Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen 5-325 Receives: Drug: Hydrocodone-Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Levels
Patients recorded pain levels 3 times per day using Visual analog scales until study completion. Average daily pain was calculated for each patient. Higher values portend worse control.
Measured: 10 days post-operatively
Patient-Reported Outcomes Measurement Information System
Patient-Reported Outcomes Measurement Information System Physical Interference (PROMIS PI) nightly until study completion. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference.
Measured: 10 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start22 Jan 2019
- Primary completion20 Jan 2020 (estimated)
- Study completion20 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcotic UseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toufic R. Jildeh, Henry Ford Health System
- Investigators
- Toufic R Jildeh, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825809
- Sponsor's protocol ID
- 1231914
- Status last verified
- Jan 2019
- First submitted
- 27 Jan 2019
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Per request
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional vs. Nonopioid Analgesia After Labral Surgery
- ClinicalTrials.gov ID
- NCT03825809
- Acronym / sponsor ID
- 1231914
- Conditions
- Narcotic Use
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 20 Jan 2020 (estimated)
- Study completion
- 20 May 2020 (estimated)
- First posted
- 31 Jan 2019 (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 is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen
Detailed description
Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring rotator cuff repair will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty.
Patients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia
Primary endpoints is reduction in pain as measured by VAS and PROMIS. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure.
Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-Operative Non Opioid Pain Protocol | Experimental | Drug: Celecoxib, Drug: Ketorolac, Drug: Gabapentin, Drug: Acetaminophen, Drug: DiazepamPatients will be administered a post-operative non-opioid pain protocol consisting of: Celecoxib Ketorolac Gabapentin Acetaminophen Diazepam |
| Post-Operative Traditional Pain Protocol | Active comparator | Drug: Hydrocodone-AcetaminophenPatients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen 5-325 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients over age 18 and scheduled for a primary or revision labral surgery
Key exclusion criteria (1 listed)
- Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact rotator cuff
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 |
|---|---|---|
| CelecoxibAlso: CelebrexPost-Operative Non Opioid Pain Protocol | Drug | Post-Operative Non Opioid Pain Protocol |
| Hydrocodone-AcetaminophenAlso: NorcoTraditionally used narcotic pain protocol | Drug | Post-Operative Traditional Pain Protocol |
| KetorolacAlso: ToradolPost-Operative Non Opioid Pain Protocol | Drug | Post-Operative Non Opioid Pain Protocol |
| GabapentinAlso: NeurontinPost-Operative Non Opioid Pain Protocol | Drug | Post-Operative Non Opioid Pain Protocol |
| AcetaminophenAlso: TylenolPost-Operative Non Opioid Pain Protocol | Drug | Post-Operative Non Opioid Pain Protocol |
| DiazepamAlso: ValiumPost-Operative Non Opioid Pain Protocol | Drug | Post-Operative Non Opioid Pain Protocol |
Primary outcome
Pain Levels
Time frame: 10 days post-operatively
Patients recorded pain levels 3 times per day using Visual analog scales until study completion. Average daily pain was calculated for each patient. Higher values portend worse control.
Patient-Reported Outcomes Measurement Information System
Time frame: 10 days post-operatively
Patient-Reported Outcomes Measurement Information System Physical Interference (PROMIS PI) nightly until study completion. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: Undecided. Per request
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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.
Toufic R Jildeh, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Celecoxib, Hydrocodone-Acetaminophen and Ketorolac in people with Narcotic Use, run by Henry Ford Health System 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 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: looking for participants now, as of the sponsor's last update on 31 Jan 2019. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toufic R Jildeh, MD (517-230-8511, tjildeh1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Levels (time frame: 10 days post-operatively). 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 31 Jan 2019.