Carpal TunnelPhase 4NCT01974609
Narcotic vs. Non-narcotic Pain Study Protocol
A Phase 4 study testing Narcotic and non-narcotic in people with Carpal Tunnel, run by Horizon Health Network at 7 sites in 2 countries.
Trial summary
The purposes of this noninferiority randomized clinical trial are to: 1. determine whether the most commonly used commonly used non-narcotic analgesic (ibuprofen 600 mg + acetaminophen 325 mg) provides pain relief that is not unacceptably worse than the most commonly prescribed narcotic containing analgesic… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carpal Tunnel
- What is being tested?
- Narcotic and non-narcotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Mar 2016to 24 Feb 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing elective a primary carpal tunnel release will be considered eligible
Who cannot join
- Patients wil be excluded for any of the following:
- previously enrolled in this study (for carpal tunnel surgery on the other hand);
- history of chronic opioid use;
- documented or suspected substance abuse;
- individuals currently on daily use of ibuprofen, acetaminophen or other pain altering medication including medications like Neurontin (gabapentin) and Ultram (tramadol)
- individuals with documented or suspected chronic pain syndrome;
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- reported allergy or adverse reaction to hydrocodone, acetaminophen, or ibuprofen;
- those with a history or symptoms of any significant medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease);
- patients with active peptic ulcer disease (history of severe heartburn);
- symptoms of infection with initial enrollment;
- pregnant or lactating women;
- those with a diagnosis of cognitive impairment;
- patients unable or unwilling to provide informed consent for surgery or enrollment in a clinical trial;
- patients unable or unwilling to fill out the forms or understand the consent form
- prior carpal tunnel surgery on the hand to be operated on
- individuals currently taking Coumadin, Plavix, or medications that increase bleeding; or
- patients with other medical or psychological health conditions that preclude then from receiving either intervention or returning for follow-up visits
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Canada4 sites
Lawson Health Research Institute
London, Ontario, N6A 4V2
University of Western Ontario, Canada
London, Ontario
McGill University
Montreal, Quebec, H3A 0G4
Horizon Health Network
Saint John, New Brunswick, E2L 4L4
United States3 sites
The Philadelphia Hand Center
Philadelphia, Pennsylvania, 19107
CarilionClinic
Roanoke, Virginia, 24014
Sanford orthopedics and Sports Medicine-Sioux Falls
Sioux Falls, South Dakota, 57104
About this study
Official title: A Randomized, Controlled Trial Comparing Combination Therapy of Ibuprofen + Acetaminophen Versus Hydrocodone + Acetaminophen for the Treatment of Pain After Carpal Tunnel Surgery
The purposes of this noninferiority randomized clinical trial are to:
- determine whether the most commonly used commonly used non-narcotic analgesic (ibuprofen 600 mg + acetaminophen 325 mg) provides pain relief that is not unacceptably worse than the most commonly prescribed narcotic containing analgesic (hydrocodone 5 mg. + acetaminophen 325 mg, equivalent to Norco 5/325) in patients undergoing carpal tunnel release.
- Determine whether the following covariates affect pain level following surgery or medication usage: gender, country (US/Canada), pre-operative CTS symptoms, site, workers compensation status and employment status (employed/self-employed/unemployed-able to work/unemployed-unable to work)
Read the detailed description
Participants will be provided with forms by site coordinators and will be provided in person instruction on how to fill out the pain intensity scores, the pain interference scores, the pain medication diary, and the final pain relief assessment form.
Medications will be identified only by number and will be available to the participant after standard instruction on use of medications is provided by the surgeon or research associate. Patients will be instructed - verbally and written - to take the study medication (2 capsules per dose) up to four times per day as needed for pain for 1 week or until pain free.
If patients experience intolerable discomfort, they will be able to contact personnel (24 hours on call) associated with the study to receive an alternate analgesic. The surgeon will determine if the patient is taking the maximum dose and then prescribe additional study drug or a non-study drug as an alternative. If the patient receives pain medication outside of the study protocol, the medication will be recorded, this will be recorded as a protocol violation. If this occurs in more than 20 people during the trial a per-protocol and efficacy analysis will be considered.
Participants will return to see the surgeon or designate between post-operative day 7 and 14 to return their diary, unused medication, and post-operative pain satisfaction survey. Participants will be specifically asked about: any adverse events, compliance with the program and the reason for any deviation and any other analgesic medication taken during the course of the study.
- Conditions
- Carpal Tunnel
- Being tested
- Narcotic, non-narcotic
- Keywords
- pain relief, narcotic pain relief, non-narcotic pain relief, post-operative pain relief, carpal tunnel
- Medical subject headings
- Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NarcoticDrug
Also called Hydrocodone/acetaminophen
Hydrocodone 5mg + acetaminophen 325 mg
non-narcoticDrug
Also called ibuprofen + acetaminophen
ibuprofen 600mg + acetaminophen 325 mg
| Study group | Role | What they receive |
|---|---|---|
| Narcotic | Experimental | Hydrocodone + acetaminophen 4 times per day 1 week after surgery Receives: Drug: Narcotic |
| non-narcotic | Active comparator | ibuprofen + acetaminophen 4 times per day 1 week after surgery Receives: Drug: non-narcotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
- Determine whether the most commonly used nonnarcotic analgesics (ibuprofen 600 mg + acetaminophen 325 mg) provide pain relief that is not unacceptably worse than the most commonly prescribed narcotic containing analgesic (hydrocodone 5 mg + acetaminophen 325 mg, equivalent to Norco® 5/325) in patients undergoing carpal tunnel release.
Measured: 7-15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startMar 2016
- Primary completion24 Feb 2022
- Study completion24 Feb 2022
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 Carpal TunnelStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horizon Health Network
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, University of Michigan, Jefferson Medical College of Thomas Jefferson University, McGill University, University of Western Ontario, Canada, Sanford Health, Carilion Clinic
- Responsible party
- Principal investigator, Don Lalonde MD, Horizon Health Network
- Investigators
- Donald Lalonde, MD, Principal investigator, Saint John, NB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974609
- Sponsor's protocol ID
- Narcotic vs. Non-narcotic Pain
- Status last verified
- Feb 2022
- First submitted
- 28 Oct 2013
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lalonde DH, Lalonde JF, MacDermid JC, Chung KC, Gan BS, Mierisch C, Van Demark RE Jr, Luc M. Time to Stop Routinely Prescribing Opiates after Carpal Tunnel Release. Plast Reconstr Surg. 2022 Mar 1;149(3):651-660. doi: 10.1097/PRS.0000000000008834.
PubMed 35041636
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Comparing Combination Therapy of Ibuprofen + Acetaminophen Versus Hydrocodone + Acetaminophen for the Treatment of Pain After Carpal Tunnel Surgery
- ClinicalTrials.gov ID
- NCT01974609
- Acronym / sponsor ID
- Narcotic vs. Non-narcotic Pain
- Conditions
- Carpal Tunnel
- Keywords
- pain relief, narcotic pain relief, non-narcotic pain relief, post-operative pain relief, carpal tunnel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Horizon Health NetworkUniversity, hospital or other
- Collaborators
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, University of Michigan, Jefferson Medical College of Thomas Jefferson University, McGill University, University of Western Ontario, Canada, Sanford Health, Carilion Clinic
- Study start
- Mar 2016
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 1 Nov 2013 (estimated)
- 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 purposes of this noninferiority randomized clinical trial are to:
- determine whether the most commonly used commonly used non-narcotic analgesic (ibuprofen 600 mg + acetaminophen 325 mg) provides pain relief that is not unacceptably worse than the most commonly prescribed narcotic containing analgesic (hydrocodone 5 mg. + acetaminophen 325 mg, equivalent to Norco 5/325) in patients undergoing carpal tunnel release.
- Determine whether the following covariates affect pain level following surgery or medication usage: gender, country (US/Canada), pre-operative CTS symptoms, site, workers compensation status and employment status (employed/self-employed/unemployed-able to work/unemployed-unable to work)
Detailed description
Participants will be provided with forms by site coordinators and will be provided in person instruction on how to fill out the pain intensity scores, the pain interference scores, the pain medication diary, and the final pain relief assessment form.
Medications will be identified only by number and will be available to the participant after standard instruction on use of medications is provided by the surgeon or research associate. Patients will be instructed - verbally and written - to take the study medication (2 capsules per dose) up to four times per day as needed for pain for 1 week or until pain free.
If patients experience intolerable discomfort, they will be able to contact personnel (24 hours on call) associated with the study to receive an alternate analgesic. The surgeon will determine if the patient is taking the maximum dose and then prescribe additional study drug or a non-study drug as an alternative. If the patient receives pain medication outside of the study protocol, the medication will be recorded, this will be recorded as a protocol violation. If this occurs in more than 20 people during the trial a per-protocol and efficacy analysis will be considered.
Participants will return to see the surgeon or designate between post-operative day 7 and 14 to return their diary, unused medication, and post-operative pain satisfaction survey. Participants will be specifically asked about: any adverse events, compliance with the program and the reason for any deviation and any other analgesic medication taken during the course of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narcotic | Experimental | Drug: NarcoticHydrocodone + acetaminophen 4 times per day 1 week after surgery |
| non-narcotic | Active comparator | Drug: non-narcoticibuprofen + acetaminophen 4 times per day 1 week after surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing elective a primary carpal tunnel release will be considered eligible
Key exclusion criteria (17 listed)
- Patients wil be excluded for any of the following:
- previously enrolled in this study (for carpal tunnel surgery on the other hand);
- history of chronic opioid use;
- documented or suspected substance abuse;
- individuals currently on daily use of ibuprofen, acetaminophen or other pain altering medication including medications like Neurontin (gabapentin) and Ultram (tramadol)
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 |
|---|---|---|
| NarcoticAlso: Hydrocodone/acetaminophenHydrocodone 5mg + acetaminophen 325 mg | Drug | Narcotic |
| non-narcoticAlso: ibuprofen + acetaminophenibuprofen 600mg + acetaminophen 325 mg | Drug | non-narcotic |
Primary outcome
Pain relief
Time frame: 7-15 days
1. Determine whether the most commonly used nonnarcotic analgesics (ibuprofen 600 mg + acetaminophen 325 mg) provide pain relief that is not unacceptably worse than the most commonly prescribed narcotic containing analgesic (hydrocodone 5 mg + acetaminophen 325 mg, equivalent to Norco® 5/325) in patients undergoing carpal tunnel release.
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 11 Mar 2022.
- Background: PubMed 35041636Lalonde DH, Lalonde JF, MacDermid JC, Chung KC, Gan BS, Mierisch C, Van Demark RE Jr, Luc M. Time to Stop Routinely Prescribing Opiates after Carpal Tunnel Release. Plast Reconstr Surg. 2022 Mar 1;149(3):651-660. doi: 10.1097/PRS.0000000000008834.
- 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.
Donald Lalonde, MD principal investigator
Saint John, NB
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Narcotic and non-narcotic in people with Carpal Tunnel, run by Horizon Health Network at 7 sites in 2 countries.
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 17 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 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, 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 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?
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?
Pain relief (time frame: 7-15 days). 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 NCT01974609, 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 11 Mar 2022.