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Trial record 7 of 57 for:    Recruiting, Not yet recruiting, Available Studies | Arthroscopy

Efficacy of Multimodal Analgesia Following Hip Arthroscopy

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ClinicalTrials.gov Identifier: NCT03351439
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Ryan Degen, Western University, Canada

Brief 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.


Condition or disease Intervention/treatment Phase
Hip Pain Chronic Drug: Zopiclone Drug: Gabapentin Drug: Celebrex Drug: Percocet Drug: Naprosyn Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Multimodal Analgesia Following Hip Arthroscopy
Actual Study Start Date : April 6, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Standard of Care

Drug: Naprosyn
Standard of Care

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

Drug: Percocet
Standard of Care

Drug: Naprosyn
Standard of Care

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

Drug: Percocet
Standard of Care

Drug: Naprosyn
Standard of Care

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

Drug: Percocet
Standard of Care

Drug: Naprosyn
Standard of Care




Primary Outcome Measures :
  1. Change in Pain Score [ Time Frame: Baseline, 1, 2, 6, 24hr post-op, daily for 1 week, every other day for 6 weeks ]
    Visual Analog Scale 0-100 to determine daily hip pain; 0=extreme pain, 100=no pain


Secondary Outcome Measures :
  1. Change in Patient Satisfaction [ Time Frame: Daily for 1 week, every other day for 6 weeks ]
    Visual Analog Scale 0-100 to determine satisfaction with pain control; 0=extremely dissatisfied; 100=extremely satisfied

  2. Change in Length of Stay [ Time Frame: 24 hrs ]
    Records the length of stay in hospital post-operative

  3. Change in Post-operative Complication Rates [ Time Frame: 24 hours ]
    Records any post-op complications

  4. Change in Post-operative Narcotic Consumption [ Time Frame: 2 weeks ]
    Diary to record pain medication consumption

  5. Cost Diary [ Time Frame: Weekly for 6 weeks ]
    Patient reported diary to record hospital and personal expenses



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351439


Contacts
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Contact: Stacey Wanlin 519-661-2111 ext 82705 swanlin@uwo.ca
Contact: Andrew Firth, MSc 519-661-2111 ext 88834 afirth5@uwo.ca

Locations
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Canada, Ontario
Fowler Kennedy Sport Medicine Clinic Recruiting
London, Ontario, Canada, N6A 3K7
Contact: Ryan M Degen, MD    519-661-2171    ryan.degen@lhsc.on.ca   
Contact: Stacey Wanlin       swanlin@uwo.ca   
Principal Investigator: Ryan M Degen, MD         
Principal Investigator: Kevin Willits, MD         
Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Ryan Degen, MD, FRCSC Fowler Kennedy Sport Medicine Clinic

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Responsible Party: Ryan Degen, Associate Professor, Western University, Canada
ClinicalTrials.gov Identifier: NCT03351439     History of Changes
Other Study ID Numbers: 110350
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ryan Degen, Western University, Canada:
Hip Arthroscopy

Additional relevant MeSH terms:
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Gabapentin
Celecoxib
Naproxen
Zopiclone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Hypnotics and Sedatives
Gout Suppressants