Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients
Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients
The study is a prospective, randomized, open-label comparison of a multimodal regimen and a
 standard, narcotic-based regimen for postoperative pain control in patients undergoing
 surgery for an operatively indicated, isolated extremity fracture. The investigators will be
 measuring pain levels, narcotic use, patient satisfaction, patient reported function, adverse
 events and fracture union. The investigators hypothesize that this multimodal regimen will
 lead to improved pain, less narcotic use and improved satisfaction as compared to the
 standard regimen.
Patients will be assessed for inclusion or exclusion during admission to the hospital or
 during evaluation in the clinic or emergency room for an isolated extremity fracture for
 which surgery is indicated. Once enrolled in the study and consent obtained, patients will be
 randomized into either the standard therapy group or the multimodal therapy group using
 permuted block randomization based on injury site. The sites of fracture are as follows:

 -  wrist/hand/forearm

 -  elbow/upper arm/shoulder

 -  acetabulum/pelvis

 -  foot/ankle

 -  patella/tibia (shaft, proximal)

 -  femur (proximal to distal)

 The investigators have assumed that these distinct areas result in a similar amount of
 disability and pain as compared to the other sites. This is an attempt to mitigate the
 possible confounder of disproportionate numbers of more painful or more debilitating injuries
 falling in one study group compared to another.

 Pre-operatively, patient demographic data will be recording including age, gender, BMI, hand
 dominance, occupation, use of tobacco/alcohol/illicit drugs, use of assistive devices,
 relevant comorbidities (i.e., diabetes), site of injury, mechanism and energy (high or low).
 If there is to be a delay between initial presentation and surgery, as is often the case for
 distal radius or ankle fractures, among others, multimodal patients will begin their therapy
 immediately after evaluation. Thus, they will be started on scheduled 1000mg acetaminophen
 and 100mg gabapentin both three times daily. They will also be provided an 5mg oxycodone
 prescription with instructions to take 1-3 tablets every 4 hours as needed for pain. Standard
 therapy patients will be prescribed oxycodone alone, using the same parameters, with the
 ability to take acetaminophen on an as needed basis.

 Pre-operatively, multimodal patients will receive 1000mg IV acetaminophen, 100mg PO
 gabapentin and 400mg PO celecoxib. All patients will have a peripheral nerve block placed
 when indicated, to confirm to the investigators standard of care. Patients will then undergo
 surgery with the investigators standardized anesthesia protocol as described in the protocol.
 Intraoperatively, multimodal patients will receive 8mg of IV dexamethasone. Post-operatively,
 multimodal patients will be given 1000mg acetaminophen three times daily for the duration of
 their narcotic use and 100mg Gabapentin three times daily for 1 week, which will be titrated
 to 200mg three times daily for 1 additional week. They will also receive an oxycodone
 prescription as described previously. Standard therapy patients will be given an oxycodone
 prescription alone with the advice to take tylenol on an as needed basis not to exceed
 4000mg/day. No placebo medications will be used as this is an open label study.

 Patients will be instructed to avoid all anti-inflammatory medications. All patients across
 groups will be given aspirin 81mg for deep vein thrombosis prophylaxis if they suffered a
 lower extremity fracture. Should a patient require an alternative deep vein thrombosis
 prophylaxis regimen due to an allergy to aspirin or a personal history of deep vein
 thromboses, low molecular weight heparin will be used.

 Patients will be given a diary to record their daily narcotic use, daily minimum, maximum and
 average pain scores using a visual analog scale and any side effects. Patients will be
 provided the contact information of the attending surgeon's nurse to report any serious
 allergies or adverse effects of the study medications. A case by case decision will be made
 to either continue the protocol or to drop the patient from the study and make needed
 medications changes.

 Patients will be followed at defined time points after surgery including, 2 wks, 6wks, 3mo
 and 6mo.

 At their 2 wk follow up visit they will fill out the Short Musculoskeletal Function
 Assessment for their preoperative functional state as well as the American Pain Society
 Patient Satisfaction Questionnaire. These will again be filled out at their 3 and 6 month
 visits. Union will be assessed at their 3 and 6 month visits by a third party, blinded
 observed. It will be defined as three cortices of bridging callus on 2 orthogonal views. Once
 fracture union occurs or nonunion is identified control patients will be allowed to use non
 steroidal anti-inflammatories as needed. Time to return to work/normal activity, total
 narcotic usage and duration of narcotic use will also be recorded.
Inclusion Criteria:

 -  Bone fracture

 -  Isolated injury

 -  Requires operative intervention

 Exclusion Criteria:

 -  pathological fractures

 -  inability to personally consent to participation due to cognitive impairment,
 intoxication or sedation

 -  severe head injury

 -  polytrauma patients with multiple fractures or other injuries

 -  pregnancy

 -  open fractures

 -  metabolic bone disease

 -  allergies or contraindications to the study medications, including sulfa medications.

 -  prior or current drug or alcohol dependence or abuse

 -  liver or kidney disease

 -  physician directed narcotic use