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Hip Pain ChronicNCT03351439

Efficacy of Multimodal Analgesia Following Hip Arthroscopy

A study testing Zopiclone, Gabapentin and Celebrex in people with Hip Pain Chronic, run by Western University, Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the full study is to determine whether multimodal analgesia for hip arthroscopy will reduce post-operative pain scores, narcotic consumption and hospital length-of-stay. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hip Pain Chronic
What is being tested?
Zopiclone, Gabapentin and Celebrex
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCanada
Study dates
6 Apr 2018to 30 Sep 2021
Phase
Interventional
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • any patient between the ages of 18 and 60 years undergoing hip arthroscopy by one of three fellowship-trained hip arthroscopists

Who cannot join

  • radiographic signs of osteoarthritis (Tönnis grade 2 or higher), an American Society of Anesthesiologists (ASA) classification of 3 or higher,
  • allergy to sulfa-based drugs,
  • adverse reactions to any of the potential study medications, or a
  • history of chronic pain, substance abuse or
  • pregnancy

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Fowler Kennedy Sport Medicine Clinic

    London, Ontario, N6A 3K7

Other trials in Canada

About this study

The purpose of the full study is to determine whether multimodal analgesia for hip arthroscopy will reduce post-operative pain scores, narcotic consumption and hospital length-of-stay. To do this, the investigators will compare the standard of care (SOC), with routine pain management with a post-operative opioid prescription, to three different groups with multi-modal analgesia (SOC+peri-operative celecoxib, SOC+peri-operative gabapentin, and SOC+post-operative zopiclone).

The investigators hypothesize that administration of multi-modal analgesia in all three treatment groups will result in improved post-operative pain control, reduced post-operative narcotic consumption and an overall reduction in post-operative length-of-stay compared to the group receiving treatment as per the standard of care. However, prior to undertaking a large multi-centre study, the investigators need to determine whether the study is feasible from data obtained with this pilot study.

Read the detailed description

This pilot study will be a randomized controlled trial, where the surgical team, data collector, and patient will be blinded to the treatment received. The investigators will include any patient between the ages of 18 and 60 years undergoing hip arthroscopy by one of three fellowship-trained hip arthroscopists. The investigators will exclude patients with any radiographic signs of osteoarthritis (Tönnis grade 2 or higher), an American Society of Anesthesiologists (ASA) classification of 3 or higher, allergies to sulfa-based drugs, adverse reactions to any of the potential study medications, or a history of chronic pain or substance abuse.

Patients will be randomized in a 1:1:1:1 ratio into one of four groups:

  1. Group 1 - Standard of Care (SOC): Opioid medication (Oxycodone-acetaminophen 5 mg/325 mg, 1-2 tabs every 6 hours as needed), Heterotopic ossification prophylaxis - Naprosyn 500 mg twice daily x 3 weeks);
  2. Group 2 - SOC + Post-operative sleeping aid (Zopiclone 7.5 mg nightly x 7 days);
  3. Group 3 - SOC + Pre-operative and Post-operative Gabapentin (600 mg orally, 1 hour pre-operatively; 600 mg 8 hours post-operatively);
  4. Group 4 - SOC + Pre-medicate with Celebrex (400 mg orally, 1 hour pre-operatively)

A member of the research team will ensure that the surgeons, data collectors, and patients remain blinded to the treatment group and by performing all randomization and medication administration. For those patients randomized to the celebrex or gabapentin groups, a dose of each respective medication will be administered 1 hour before arthroscopic surgery. To maintain blinding, patients in the SOC group and zopiclone groups will receive a lactose-based placebo at the same time. Post-operatively, patients randomized to the zopiclone group will receive a prescription to be taken at night. Patients in the other three groups will receive lactose-based placebo pills for the same duration, again to maintain blinding.

All patients will receive similar treatment for their hip arthroscopy. All surgeries will be performed in the supine position utilizing a hip distraction system (Smith and Nephew, Andover MA). The procedure will be performed with use of a general anesthetic without regional anesthesia. Pathology will be identified and treated at the discretion of the primary surgeon. Patients will receive a standardized anesthetic regimen intra-operatively. Portal sites will be injected with a total of 20cc of bupivacaine. Following the procedure, all patients will be managed with a standardized post-operative analgesic regimen and subsequently discharged with a prescription for oral analgesics and prophylaxis against heterotopic ossification. Patients will be instructed to retain and return any unused narcotics at subsequent follow-up at the 2-week post-operative visit. Patients will be encouraged to request additional prescriptions through their surgeons' office for tracking, although a chart review will be performed to evaluate for any additional emergency department visits post-operatively.

The investigators will collect demographic information, including age and sex, and intra-operative data as to the surgical procedures performed including potential confounders like the duration of traction time, and dose of intraoperative narcotics. The investigators will measure pain preoperatively using a pain visual analog scale (VAS). Postoperatively, patients will again be evaluated for pain with using the same VAS at 1 hour, 2 hours, 6 hours, 24 hours, daily for 7 days and every other day for 6 weeks. Post-operatively, in hospital complications including nausea/vomiting/urinary retention will be recorded. Patient satisfaction will also be evaluated at 24 hours, 48 hours, daily for 7 days and every other day for 6 weeks. The total quantity of narcotics consumed will be calculated after accounting for unused medications returned post-operatively and additional prescription requests. Lastly, the hospital length-of-stay and associated costs will be calculated form the patients hospital records. Patients will also be administered a questionnaire on cost-reporting to evaluate for any costs due to visits to any emergency room, other physician, additional visits to rehabilitation or pain specialists, additional medications including over-the-counter medications obtained by the patient or those prescribed by another physician on a weekly basis for 6 weeks.

The investigators will consecutively approach all patients undergoing a hip arthroscopy until 100 patients are eligible and give their consent to participate (approximately one year from study commencement). This number of patients will provide a sufficient sample size to accurately estimate the proportion of eligible patients who will give their consent (the study will be sufficiently powered to provide the estimate with a 95% confidence interval around the estimate where half the width of the confidence interval [CI] is no greater than 0.05).

Being tested
Zopiclone, Gabapentin, Celebrex, Percocet, Naprosyn
Keywords
Hip Arthroscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZopicloneDrug

    Group 2 - Zopiclone 7.5 mg orally, nightly for 7 days

  • GabapentinDrug

    Group 3 - Gabapentin 600 mg orally, 1 hour pre-operatively and 600 mg orally, 8 hours post-operatively

  • CelebrexDrug

    Group 4 - Celebrex 400 mg PO, 1 hour pre-operatively

  • PercocetDrug

    Standard of Care

  • NaprosynDrug

    Standard of Care

Study groups in NCT03351439
Study groupRoleWhat they receive
Group 1Active comparatorOxycodone-acetaminophen 5 mg/325 mg, 1-2 tabs every 6 hours as needed for 60 tabs Naprosyn 500 mg twice daily x 3 weeks
Receives: Drug: Percocet; Drug: Naprosyn
Group 2ExperimentalOxycodone-acetaminophen 5 mg/325 mg, 1-2 tabs every 6 hours as needed for 60 tabs Naprosyn 500 mg twice daily for 3 weeks Zopiclone 7.5 mg nightly for 7 days
Receives: Drug: Zopiclone; Drug: Percocet; Drug: Naprosyn
Group 3ExperimentalOxycodone-acetaminophen 5 mg/325 mg, 1-2 tabs every 6 hours as needed for 60 tabs Naprosyn 500 mg twice daily for 3 weeks Gabapentin 600 mg pre-operatively for one dose and 600 mg post-operatively for one dose
Receives: Drug: Gabapentin; Drug: Percocet; Drug: Naprosyn
Group 4ExperimentalOxycodone-acetaminophen 5 mg/325 mg, 1-2 tabs every 6 hours as needed for 60 tabs Naprosyn 500 mg twice daily for 3 weeks Celebrex 400 mg pre-operatively for one dose
Receives: Drug: Celebrex; Drug: Percocet; Drug: Naprosyn

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pain Score

    Visual Analog Scale 0-100 to determine daily hip pain; 0=extreme pain, 100=no pain

    Measured: Baseline, 1, 2, 6, 24hr post-op, daily for 1 week, every other day for 6 weeks

Secondary outcomes (5)
  1. Change in Patient Satisfaction

    Visual Analog Scale 0-100 to determine satisfaction with pain control; 0=extremely dissatisfied; 100=extremely satisfied

    Measured: Daily for 1 week, every other day for 6 weeks

  2. Change in Length of Stay

    Records the length of stay in hospital post-operative

    Measured: 24 hrs

  3. Change in Post-operative Complication Rates

    Records any post-op complications

    Measured: 24 hours

  4. Change in Post-operative Narcotic Consumption

    Diary to record pain medication consumption

    Measured: 2 weeks

  5. Cost Diary

    Patient reported diary to record hospital and personal expenses

    Measured: Weekly for 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2017
  2. Study start6 Apr 2018
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03351439
Sponsor's protocol ID
110350
Status last verified
Oct 2021
First submitted
16 Nov 2017
Last updated
15 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Zopiclone, Gabapentin and Celebrex in people with Hip Pain Chronic, run by Western University, Canada at 1 site in Canada.

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 5 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 15 Oct 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 Canada. 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?

Change in Pain Score (time frame: Baseline, 1, 2, 6, 24hr post-op, daily for 1 week, every other day for 6 weeks). 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 15 Oct 2021.

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