Narcotic vs. Non-narcotic Pain Study Protocol

Participants will be provided with forms by site coordinators and will be provided in person
instruction on how to fill out the pain intensity scores, the pain interference scores, the
pain medication diary, and the final pain relief assessment form.

Medications will be identified only by number and will be available to the participant after
standard instruction on use of medications is provided by the surgeon or research associate.
Patients will be instructed - verbally and written - to take the study medication (2 capsules
per dose) up to four times per day as needed for pain for 1 week or until pain free.

If patients experience intolerable discomfort, they will be able to contact personnel (24
hours on call) associated with the study to receive an alternate analgesic. The surgeon will
determine if the patient is taking the maximum dose and then prescribe additional study drug
or a non-study drug as an alternative. If the patient receives pain medication outside of the
study protocol, the medication will be recorded, this will be recorded as a protocol
violation. If this occurs in more than 20 people during the trial a per-protocol and efficacy
analysis will be considered.

Participants will return to see the surgeon or designate between post-operative day 7 and 14
to return their diary, unused medication, and post-operative pain satisfaction survey.
Participants will be specifically asked about: any adverse events, compliance with the
program and the reason for any deviation and any other analgesic medication taken during the
course of the study.

Inclusion Criteria:

- All patients undergoing elective a primary carpal tunnel release will be considered
eligible

Exclusion Criteria:

- Patients wil be excluded for any of the following:

- previously enrolled in this study (for carpal tunnel surgery on the other hand);

- history of chronic opioid use;

- documented or suspected substance abuse;

- individuals currently on daily use of ibuprofen, acetaminophen or other pain altering
medication including medications like Neurontin (gabapentin) and Ultram (tramadol)

- individuals with documented or suspected chronic pain syndrome;

- reported allergy or adverse reaction to hydrocodone, acetaminophen, or ibuprofen;

- those with a history or symptoms of any significant medical problem in the last year
(i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver
disease, renal disease);

- patients with active peptic ulcer disease (history of severe heartburn);

- symptoms of infection with initial enrollment;

- pregnant or lactating women;

- those with a diagnosis of cognitive impairment;

- patients unable or unwilling to provide informed consent for surgery or enrollment in
a clinical trial;

- patients unable or unwilling to fill out the forms or understand the consent form

- prior carpal tunnel surgery on the hand to be operated on

- individuals currently taking Coumadin, Plavix, or medications that increase bleeding;
or

- patients with other medical or psychological health conditions that preclude then from
receiving either intervention or returning for follow-up visits