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

NCT02160301 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 13-2669
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain Control

Keywords

pain; postoperative; multimodal; satisfaction; narcotic

Outcome Measures

Primary Outcomes (3)

• Pain

  VAS score for pain control, daily for two weeks post op and at all follow up visits for 6 months.

  6 months

• Narcotic Use

  Measurement of both daily narcotic use in milligrams as well as the duration of narcotic treatment in days.

  2 months

• Patient Satisfaction

  Measurement of patient satisfaction with pain control regimen using the American Pain Society's Patient Outcome Questionnaire (APS-POQ).

  3 months

Secondary Outcomes (3)

• Patient function

  6 months

• Fracture Union

  6 months

• Adverse events

  6 months

Study Arms (2)

Multimodal pain control

EXPERIMENTAL

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; Drug: Acetaminophen; Drug: Celecoxib; Drug: Dexamethasone; Drug: Oxycodone

Standard pain control

ACTIVE COMPARATOR

Oxycodone 5-15mg PO q4hrs prn, Acetaminophen 1000mg PO q8hrs prn.

Drug: Acetaminophen; Drug: Oxycodone

Interventions

Gabapentin DRUG

PO

Also known as: Neurontin

Multimodal pain control

Acetaminophen DRUG

PO

Also known as: Tylenol, Acephen, Cetafen, Mapap, Q-Pap, Valorin

Multimodal pain control; Standard pain control

Celecoxib DRUG

PO

Also known as: Celebrex

Multimodal pain control

Dexamethasone DRUG

IV

Also known as: Baycadron

Multimodal pain control

Oxycodone DRUG

PO

Also known as: Roxicodone

Multimodal pain control; Standard pain control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bone fracture
• Isolated injury
• Requires operative intervention

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Chapel Hill Hospital

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (27)

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MeSH Terms

Conditions

Pain; Personal Satisfaction

Interventions

Gabapentin; Acetaminophen; Celecoxib; Dexamethasone; Calcium Dobesilate; Oxycodone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Acetanilides; Anilides; Amides; Aniline Compounds; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons

Study Officials

• Robert F Ostrum, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 10, 2014
• Study Start: November 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 19, 2017

Record last verified: 2017-05

Locations

US (1)