METRC Pain Study

Overview

Status: Active, not recruiting
Keywords: Double Blind Trial , Randomized , Pain Study , Placebo , Ankle Fracture
IRB Number: 00063678
Specialty: Orthopaedic Surgery, Orthopaedic Surgery
Sub Specialties: Foot and Ankle Surgery

Brief Summary

Primary Objective

Specific Aim 1 Evaluate the effect of standard pain management (Group 1) vs. standard pain management plus pre and peri-operative NSAIDS (Group 2) in the treatment of severe lower limb fractures.

Hypothesis 1a: When compared to patients who received standard of care pain management, patients treated with NSAIDS will: (1) have reduced post-operative opioid utilization; (2) report reduced levels of persistent pain; and (3) have noninferior rates of surgery for nonunion.

Hypothesis 1b: When compared to patients who received standard of care pain management, patients treated with NSAIDs will benefit from (1) improved post-operative pain control; (2) improved pre-operative pain control; (3) reduced lengths of stay; (4) reduced pain interference; (5) improved functional outcomes; (6) lower levels of depression and post-traumatic stress disorder (PTSD); (7) improved overall health status; and (8) have noninferior rates of analgesic treatment related side effects.

Secondary Objectives

Specific Aim 2: Evaluate the effect of standard pain management (Group 1) vs. standard pain management plus pre and peri-operative pregabalin (Lyrica) (Group 3) in the treatment of severe lower limb fractures.

Hypothesis 2a: When compared to patients who received standard of care pain management, patients treated with pregabalin will: (1) have reduced post-operative opioid utilization; (2) report reduced levels of persistent pain; and (3) have noninferior rates of surgery for nonunion.

Hypothesis 2b: When compared to patients who received standard of care pain management, patients treated with pregabalin will benefit from (1) improved post-operative pain control; (2) improved pre-operative pain control; (3) reduced lengths of stay; (4) reduced pain interference; (5) improved functional outcomes; (6) lower levels of post traumatic stress disorder (PTSD); (7) improved overall health status; and (8) have noninferior rates of analgesic treatment related side effects.

Specific Aim 3: Estimate the incremental cost effectiveness of each adjunctive analgesic therapy relative to standard of care analgesic therapy in the treatment of severe lower limb fractures. Costs will be estimated from both the health care provider perspective and the societal perspective. The time horizon for cost-effectiveness analysis will be based on the actual period of observation (12-24 months). Incremental cost-effectiveness ratios will be calculated for: (a) study group 2 (NSAIDS) relative to standard of care; and (b) study group 3 (pregabalin) relative to standard of care. For purpose of cost-effectiveness analysis, effect will be measured as unit change in specific outcome metrics at 12 months (or longer period as available) compared to baseline. The following cost-effectiveness metrics, all relative to standard of care, will be reported:

  • incremental cost per unit change in the Brief Pain Inventory
  • incremental cost per unit change in the Short Muscular Function Assessment (SFMA)
  • incremental cost per unit change in the health state preference ("utility") as derived from the VR-12

 

 

Principal Investigator: Thomas Higgins
Department: Orthopedic Surgery
Co Investigator:

Contact Information

Name:Nousheen Alasti
Phone: 801-587-5488
Email: Nousheen.Alasti@hsc.utah.edu

Inclusion Criteria

1.      Patients with isolated, unilateral, Grade I &II open or closed pilon (distal tibial plafond) or calcaneus fractures requiring operative treatment with fixation.

2.      Patients 18-80 years old inclusive.

3.      Patients who are English or Spanish competent.

4.      Treating physicians agree that none of the study drugs are indicated for standard of care treatment for this patient.

5.      Patients able to be followed at the METRC facility for at least 12 months following definitive surgical procedure.

Exclusion Criteria

1.      Patient unable to provide informed consent

2.      Patients with chronic pain being presently treated with opioid or gabapentinoid prescription or any other alternative therapy.

3.      Patients who are current IVDA

4.      Patients who receive definitive fixation within 48 hours of injury

5.      Patients with bilateral or ipsilateral injuries requiring surgery

6.      Patients with other orthopedic or non-orthopedic injuries requiring operative intervention

7.      Patients with severe osteopenia.

8.      Patients who are skeletally immature (defined as less than 18 years of age or no radiographic evidence of epiphyseal closure).

9.      Transfer patients with a length of stay of > 24 hours at the transferring hospital..

10.  Patients who are expected to have a post-surgical stay less than 24 hours.

11.  Patients with a history of allergy to any drugs in the study.

12.  Patients unable to swallow oral medications or without adequately functioning GI tract.

13.  Patients with a history of gastrointestinal bleeds or gastric perforation.

14.  Patients currently receiving an aspirin or NSAID regimen.

15.  Patients with any bleeding disorders.

16.  Patients with severe renal failure.  Patients with moderate renal failure may participate in the study at a modified dose.  See Section 9.6.

17.  Patients undergoing daily treatment with systemic glucocorticoids before surgery.

18.  Patients using angiotensin-converting enzyme (ACE) inhibitors, who may be at increased risk of developing angioedema with pregabalin.

19.  Patients likely to have severe problems maintaining follow-up, including patients diagnosed with a severe psychiatric conditions, patients who live too far outside the hospital’s catchment area, patients who are incarcerated and patients who have unstable housing situations.

20.  Patients who experienced a loss of consciousness consistent with a clinical diagnosis of a closed head injury, or concern of a cerebrovascular bleed secondary to traumatic brain injury.

21.  Patients with a GCS <15

22.  Patient speaks neither English nor Spanish.

23.  Patients who are pregnant or lactating at time of screening