ClinicalTrials.gg
CompletedNCT03351439Updated Oct 15, 2021

Efficacy of Multimodal Analgesia Following Hip Arthroscopy

An interventional study of Zopiclone and Gabapentin in Hip Pain Chronic, sponsored by Western University, Canada. Completed at 1 site in Canada. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-10-15.

Sponsored by Western University, Canada · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 10 studies testing gabapentin in Chronic Pain — none open to participants now, none under way, none of them phase 3. Gabapentin · Chronic Pain.

Enrollment
2nd of 10
100 · median 43
Started
2018
with 1 other
No phase
Only one
of the 10
Registered
8th of 10
by date
Lead sponsor
1 of 10
Western University, Canada

Among the 10 studies testing gabapentin in Chronic Pain, this one is the 2nd largest by enrollment, is one of 2 that started in 2018, is the only one with no phase, and was the 8th registered.

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.

Browse Chronic Pain studies →

Open to participants now

None of the 10 studies testing gabapentin in Chronic Pain is open now. The open studies under Chronic Pain, anywhere →

About gabapentin

Gabapentin: first FDA approval 1993 (NEURONTIN). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 10 studies testing gabapentin in Chronic Pain as a file.
02

Study 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. 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).

03

Conditions studied

  • Hip Pain Chronic

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Keywords

  • Hip Arthroscopy
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • radiographic signs of osteoarthritis (Tönnis grade 2 or higher), an (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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Group 1

    Oxycodone-acetaminophen 5 mg/325 mg, 1-2 tabs every 6 hours as needed for 60 tabs Naprosyn 500 mg twice daily x 3 weeks

    Drug: Percocet · Drug: Naprosyn

  • Experimental
    Group 2

    Oxycodone-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

    Drug: Zopiclone · Drug: Percocet · Drug: Naprosyn

  • Experimental
    Group 3

    Oxycodone-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

    Drug: Gabapentin · Drug: Percocet · Drug: Naprosyn

  • Experimental
    Group 4

    Oxycodone-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

    Drug: Celebrex · Drug: Percocet · Drug: Naprosyn

Interventions

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

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

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

  • Standard of Care

  • Standard of Care

06

What researchers measure

Primary outcomes

  1. Change in Pain Score

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

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

Secondary outcomes

  1. Change in Patient Satisfaction

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

    Time frame: 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

    Time frame: 24 hrs

  3. Change in Post-operative Complication Rates

    Records any post-op complications

    Time frame: 24 hours

  4. Change in Post-operative Narcotic Consumption

    Diary to record pain medication consumption

    Time frame: 2 weeks

  5. Cost Diary

    Patient reported diary to record hospital and personal expenses

    Time frame: Weekly for 6 weeks

07

Study locations

1 site
  • Fowler Kennedy Sport Medicine Clinic
    London, Ontario N6A 3K7, Canada
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Sep 2021, 41 months.

Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 41 months is above that.

Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 16, 2017
First posted
Nov 22, 2017
StartActual
Apr 6, 2018
Primary completionActual
Sep 30, 2021
CompletionActual
Sep 30, 2021
Last update
Oct 15, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03351439
Responsible party
Ryan Degen (Associate Professor, Western University, Canada) — Principal investigator
First posted
Nov 22, 2017
Start date
Apr 6, 2018
Primary completion
Sep 30, 2021
Completion
Sep 30, 2021
Last update
Oct 15, 2021

Study contacts

Ryan Degen, MD, FRCSC
principal investigator · Fowler Kennedy Sport Medicine Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Zopiclone · Gabapentin · Celecoxib

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