Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome
Intervention: Acetaminophen; Vicodin
Intervention description: 325 mg; Vicodin 5/325 mg
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: carpal tunnel syndrome; Tylenol; Vicodin; pain

Summary:

      Adequate pain relief has been a priority of the Joint Commission and is featured on national
      inpatient surveys such as the H-CAHPS. When considering methods for improving satisfaction
      with pain relief in the United States, a great deal of emphasis has been placed on opioid
      pain medications. Some of this emphasis on opioid pain medication is driven by the
      pharmaceutical industry and by advocacy groups with ties to the pharmaceutical industry.

      There is evidence that the "pain is the fifth vital sign" campaign of the Joint Commission
      led to an increased incidence of prescription of opioids, but there is less evidence of
      improved satisfaction with pain relief. There is some evidence of an increase in
      opioid-related adverse events. As the sales of opioids have tripled from 1999-2008, so has
      the number of deaths caused by opioid overdose; 14,800 in 2008. The number of visits to the
      Emergency Department for opioid overdose doubled between 2004 and 2008.

      Patients in other countries take far less opioid pain medication and are equally satisfied
      with pain relief. For instance, Lindenhovius et al. found in a retrospective study that Dutch
      patients take a weak (Tramadol) or no opioid pain medication after ankle fracture surgery and
      have comparable or better satisfaction with pain relief than American patients, most of whom
      take oxycodone. That study was repeated prospectively (unpublished) and confirmed that Dutch
      patients do not feel their pain is undertreated. A study of morphine use after a femur
      fracture demonstrated that American patients used far more than Vietnamese patients (30 mg/kg
      versus 0.9 mg/kg), but were more dissatisfied with their pain relief. These sociological
      differences are striking and suggest strongly that personal factors may be the most important
      determinant of satisfaction with pain relief.

      It is our impression that most American hand surgeons give patients a prescription for an
      opioid pain medication after carpal tunnel release, and that is certainly true in our
      practice. This seems to be based primarily on the outliers, and intended to avoid
      confrontation with patients that desire opioids; however, most patients take little or no
      narcotic pain medication, and many who do use the opioids complain of the side effects-nausea
      and pruritis in particular. It is therefore not clear whether routine opioids is the optimal
      pain management strategy after carpal tunnel release. In the study of Stahl et al. from
      Israel, patients were prescribed acetaminophen rather than opioids after carpal tunnel
      release and only 20 of 50 patients used acetaminophen; 30 patients did not use acetaminophen
      or other pain medication at all after the operation.

      Our aim is to determine if there is a difference in satisfaction with pain relief between
      patients advised to take opioids compared to patients advised to use over the counter
      acetaminophen after carpal tunnel release under local anesthesia. A secondary aim is to
      determine if personal factors account for more of the variability in satisfaction with pain
      relief than opioid strategy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older.

          -  All subjects will be competent adults able to consent on their own behalf for surgery
             and care.

          -  Inclusion prior to surgery

          -  Carpal tunnel release

        Exclusion Criteria:

          -  Pregnant women. Patients will be queried with the routine preoperative medical history
             and an inclusion/exclusion checklist.

          -  Patients unable to give informed consent

          -  Non English-speaking subjects

          -  Patients with hypersensitivity to acetaminophen or hydrocodone

          -  Patients with chronic alcohol abuse

          -  Patients with severe impairment of renal or hepatic function. This will be assessed in
             the routine preoperative medical history and review of the medical record. We will
             also ask the patients specific for this history in the screening for the study
             inclusion/exclusion criteria.

          -  Patients with hypothyroidism

          -  Patients with Addison's disease

          -  Patients with prostatic hypertrophy or urethral stricture

          -  Patients using any of the following medications:

        MAO or tricyclic antidepressants Antihistaminics Antipsychotic or anti-anxiety medications
        Phenothiazines Zidovudin Phenobarbital

          -  Patients who are taking opioid pain medication for another reason prior to surgery.