Clinical trial NCT02160301: Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients
Official title: Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Post Operative Pain Control
Keywords: pain
postoperative
multimodal
satisfaction
narcotic
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: 6 months
measure: Narcotic Use
timeFrame: 2 months
measure: Patient Satisfaction
timeFrame: 3 months
Secondary outcomes:
measure: Patient function
timeFrame: 6 months
measure: Fracture Union
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill Hospital
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Robert F Ostrum, MD
role: PRINCIPAL_INVESTIGATOR
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