Efficacy of Multimodal Analgesia Following Hip Arthroscopy
Condition: Hip Pain Chronic
Study type: Interventional

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.
    

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).
    

Intervention name(s): Zopiclone; Gabapentin; Celebrex; Percocet; Naprosyn
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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
Intervention MeSH terms: Celecoxib; Naproxen; Gabapentin; Zopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hip Arthroscopy