Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients

May 17, 2017 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Chapel Hill Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multimodal pain control
Oxycodone 5-15mg PO q4hrs prn pre- and post-op, Acetaminophen 1000mg IV once pre-op, Acetaminophen 1000mg PO q8hrs pre-op and x2 weeks post op, prn thereafter, Gabapentin 100mg/200mg PO a8hrs pre-op and x2 weeks post op, Dexamethasone 8mg IV once intra-op, Celecoxib 400mg PO once pre-op.
Drug: Gabapentin
PO
Other Names:
  • Neurontin
Drug: Acetaminophen
PO
Other Names:
  • Tylenol
  • Acephen
  • Cetafen
  • Mapap
  • Q-Pap
  • Valorin
Drug: Acetaminophen
IV
Other Names:
  • Ofirmev
Drug: Celecoxib
PO
Other Names:
  • Celebrex
Drug: Dexamethasone
IV
Other Names:
  • Baycadron
Drug: Oxycodone
PO
Other Names:
  • Roxicodone
Active Comparator: Standard pain control
Oxycodone 5-15mg PO q4hrs prn, Acetaminophen 1000mg PO q8hrs prn.
Drug: Acetaminophen
PO
Other Names:
  • Tylenol
  • Acephen
  • Cetafen
  • Mapap
  • Q-Pap
  • Valorin
Drug: Acetaminophen
IV
Other Names:
  • Ofirmev
Drug: Oxycodone
PO
Other Names:
  • Roxicodone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 6 months
VAS score for pain control, daily for two weeks post op and at all follow up visits for 6 months.
6 months
Narcotic Use
Time Frame: 2 months
Measurement of both daily narcotic use in milligrams as well as the duration of narcotic treatment in days.
2 months
Patient Satisfaction
Time Frame: 3 months
Measurement of patient satisfaction with pain control regimen using the American Pain Society's Patient Outcome Questionnaire (APS-POQ).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient function
Time Frame: 6 months
Measurement of patient function using the Short Musculoskeletal Functional Assessment questionnaire.
6 months
Fracture Union
Time Frame: 6 months
Binary determination of fracture union (yes or no) during the 6 month duration of the study.
6 months
Adverse events
Time Frame: 6 months
Measurement of the rate of adverse events post operatively.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Robert F Ostrum, MD, UNC Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

June 6, 2014

First Submitted That Met QC Criteria

June 9, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 17, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-2669

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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