Rotator Cuff TearsPhase 4NCT05800847
Effect of Gabapentin on Sleep and Opioid Use Following Rotator Cuff Repair
A Phase 4 study testing Gabapentin in people with Rotator Cuff Tears, run by Hughston Clinic.
Trial summary
The goal of this clinical trial is to compare the effects of gabapentin in patients undergoing rotator cuff repair surgery. The main question it aims to answer is whether gabapentin can improve postoperative pain and sleep quality. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Jul 2024
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed traumatic or degenerative rotator cuff tear undergoing primary arthroscopic repair
- between the ages of 18 and 65 years old
Who cannot join
- chronic pre-operative narcotic pain medication use
- undergoing superior capsular reconstruction / balloon interposition etc
- < 18 y/o or > 65 y/o
- bilateral rotator cuff tear
- currently taking prescribed sleep-aid medications
- history of fibromyalgia or chronic pain syndrome
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- pain management patient
- narcolepsy diagnosis
- diagnosis of cervical radiculopathy
- reported non-shoulder pain interfering with sleep
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Gabapentin Following Arthroscopic Rotator Cuff Repair: Evaluation of Postoperative Opioid Use and Sleep Quality
The goal of this clinical trial is to compare the effects of gabapentin in patients undergoing rotator cuff repair surgery. The main question it aims to answer is whether gabapentin can improve postoperative pain and sleep quality. Participants in this study will be randomized to either take gabapentin after surgery or a placebo after surgery.
Read the detailed description
Perioperative gabapentin use has been established in prior literature to decrease postoperative opioid use; however, all of these studies have evaluated gabapentin given by an anesthesia team in the immediate pre- or intraoperative period. No known literature exists regarding scheduled post-operative oral gabapentin use in regards to pain control and opioid use. Sleep quality still tends to be a frequent concern associated with rotator cuff injury and shoulder surgery in general. The added known benefit of somnolence or drowsiness, in addition to aid in sleep, with use of gabapentin may also contribute to improved sleep quality following rotator cuff repair.
- Conditions
- Rotator Cuff Tears
- Being tested
- Gabapentin, Placebo
- Keywords
- Rotator Cuff Repair, Gabapentin, Opioid Use
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Gabapentin will be administered for 2 days at 100 mg q8h for titration to avoid side effects. The next 12 days, gabapentin will be taken at 300 mg q8h.
PlaceboDrug
Placebo will follow the same dosing pattern as gabapentin to allow for blinding. Placebo will be encapsulated with a gelatin capsule to mimic the look of gabapentin.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Patients in this arm will be receiving 100 mg placebo q8h for 2 days followed by 300 mg placebo q8h for 12 days. Patients will also receive 30 pills of hydrocodone-acetaminophen 5-325 mg q4-6h as needed. Receives: Drug: Placebo |
| Gabapentin | Experimental | Patients in this arm will be receiving 100 mg gabapentin q8h for 2 days followed by 300 mg gabapentin q8h for 12 days. Patients will also receive 30 pills of hydrocodone-acetaminophen 5-325 mg q4-6h as needed. Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage of Opioids for Pain Control
Determined based on morphine milligram equivalents
Measured: Up to 12 weeks postoperatively
Change in Sleep Quality
Determined with Patient-Reported Outcomes Measurement Information System Sleep Disturbance Scale (min: 8, max: 40, higher score represents worse sleep)
Measured: Up to 12 weeks postoperatively
Secondary outcomes (3)
Change in Pain
Determined with Visual Analog Scale (min: 0, max: 10, higher score represents more pain)
Measured: Up to 12 weeks postoperatively
Change in Functional Outcome (Based on Prior Baseline)
Determined with Single Assessment Numerical Evaluation (min: 0, max: 100, higher score represents better outcome)
Measured: Up to 12 weeks postoperatively
Change in Functional Outcome (Based on Survey)
Determined with American Shoulder and Elbow Surgeons Scores (min: 0, max: 100, higher score represents better outcome)
Measured: Up to 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hughston Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800847
- Sponsor's protocol ID
- HIRB2022-05
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin Following Arthroscopic Rotator Cuff Repair: Evaluation of Postoperative Opioid Use and Sleep Quality
- ClinicalTrials.gov ID
- NCT05800847
- Acronym / sponsor ID
- HIRB2022-05
- Conditions
- Rotator Cuff Tears
- Keywords
- Rotator Cuff Repair, Gabapentin, Opioid Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Hughston ClinicUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 6 Apr 2023 (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 goal of this clinical trial is to compare the effects of gabapentin in patients undergoing rotator cuff repair surgery. The main question it aims to answer is whether gabapentin can improve postoperative pain and sleep quality. Participants in this study will be randomized to either take gabapentin after surgery or a placebo after surgery.
Detailed description
Perioperative gabapentin use has been established in prior literature to decrease postoperative opioid use; however, all of these studies have evaluated gabapentin given by an anesthesia team in the immediate pre- or intraoperative period. No known literature exists regarding scheduled post-operative oral gabapentin use in regards to pain control and opioid use. Sleep quality still tends to be a frequent concern associated with rotator cuff injury and shoulder surgery in general. The added known benefit of somnolence or drowsiness, in addition to aid in sleep, with use of gabapentin may also contribute to improved sleep quality following rotator cuff repair.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: PlaceboPatients in this arm will be receiving 100 mg placebo q8h for 2 days followed by 300 mg placebo q8h for 12 days. Patients will also receive 30 pills of hydrocodone-acetaminophen 5-325 mg q4-6h as needed. |
| Gabapentin | Experimental | Drug: GabapentinPatients in this arm will be receiving 100 mg gabapentin q8h for 2 days followed by 300 mg gabapentin q8h for 12 days. Patients will also receive 30 pills of hydrocodone-acetaminophen 5-325 mg q4-6h as needed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed traumatic or degenerative rotator cuff tear undergoing primary arthroscopic repair
- between the ages of 18 and 65 years old
Key exclusion criteria (10 listed)
- chronic pre-operative narcotic pain medication use
- undergoing superior capsular reconstruction / balloon interposition etc
- < 18 y/o or > 65 y/o
- bilateral rotator cuff tear
- currently taking prescribed sleep-aid medications
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 |
|---|---|---|
| GabapentinGabapentin will be administered for 2 days at 100 mg q8h for titration to avoid side effects. The next 12 days, gabapentin will be taken at 300 mg q8h. | Drug | Gabapentin |
| PlaceboPlacebo will follow the same dosing pattern as gabapentin to allow for blinding. Placebo will be encapsulated with a gelatin capsule to mimic the look of gabapentin. | Drug | Control |
Primary outcome
Usage of Opioids for Pain Control
Time frame: Up to 12 weeks postoperatively
Determined based on morphine milligram equivalents
Change in Sleep Quality
Time frame: Up to 12 weeks postoperatively
Determined with Patient-Reported Outcomes Measurement Information System Sleep Disturbance Scale (min: 8, max: 40, higher score represents worse sleep)
3 secondary outcomes
Change in Pain
Time frame: Up to 12 weeks postoperatively
Change in Functional Outcome (Based on Prior Baseline)
Time frame: Up to 12 weeks postoperatively
Change in Functional Outcome (Based on Survey)
Time frame: Up to 12 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin in people with Rotator Cuff Tears, run by Hughston Clinic.
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 10 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 6 Apr 2023. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Brent A Ponce, MD (2059306722, bponce@hughston.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usage of Opioids for Pain Control (time frame: Up to 12 weeks postoperatively). 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 6 Apr 2023.