A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery
Condition: Laparoscopic Cholecystectomy; Inguinal Hernia; Abdominal Hernia; Umbilical Hernia
MeSH terms: Hernia, Umbilical; Hernia; Hernia, Inguinal; Hernia, Abdominal; Internal Hernia
Study type: Interventional

Summary: 
      Increasingly in general surgery, the investigators are conducting outpatient day surgery.
      Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America.
      These patients all require some form of analgesia which can be taken at home in the first few
      days after the surgery. The current standard at the investigators' centre and many others in
      the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or
      oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as
      oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication
      (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects,
      and may not provide effective pain relief. In the investigators' experience, non-steroidal
      anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic
      regimen.

      Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain
      medication. They hope to show that a combination of ibuprofen and acetaminophen is better for
      pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a
      safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of
      surgeons are old habits, it will require a very convincing argument to get them to change
      their practices. A randomized controlled trial comparing these two regimens, the
      investigators hope, would be a powerful enough argument.

      The hypothesis of this study, therefore, is that the pain control provided by a combination
      of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to
      Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day).

      This study will attempt to enroll 150 patients in total. Eligible patients will be identified
      by their attending surgeon and contacted by study personnel. Patients who enroll in the study
      will undergo their surgery in the usual manner. After the surgery, in the recovery room, once
      they are ready to go home, they will be randomized to receive combination A or B and be given
      a week's worth of pain medication. They will then go home and take this medication as
      directed. They will record their pain intensity and pain relief once per day using a diary
      provided in the study package. One week after their surgery, they will return to the hospital
      clinic and be seen by the study nurse. They will hand over the diary and any unused
      medication. They will also be asked several questions regarding their overall satisfaction,
      incidence of side effects, and how long until they were pain free.

      The risks of participating in this study are minimal from the risks inherent to the
      procedures and medications the patients would receive within the standard of care. Ibuprofen
      is a commonly used NSAID which is widely available over the counter and has an established
      safety profile. The most common adverse effects of ibuprofen and other NSAIDs are
      gastrointestinal bleeding and ulceration. Other less common adverse effects include
      nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive
      dysfunction. The investigators' patients will be selected to exclude those most at risk for
      these complications (see exclusion criteria). Acetaminophen has few side effects, with no
      adverse effects on platelet function and no evidence of gastric irritation.
    


Intervention name(s): Tylenol #3; Combination Tylenol and Ibuprofen
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Outpatient Surgery for:; inguinal hernia repair; abdominal hernia repair; umbilical hernia repair