Perioperative Pain Management In Spine Surgery Patients: Part I

NCT01447888 | Completed Results

• 1 other identifier: 3436-3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is a comparison of pain management in opioid-tolerant spine surgery patients using a perioperative dosing goal of 150% of patient's baseline oral morphine equivalent (OME), as compared to standard perioperative dosing, which does not currently account for patients' baseline opiate use.

Conditions

Pain

Keywords

Spine surgery; Chronic pain; Opioid tolerant; Pain management in spine surgery patients

Outcome Measures

Primary Outcomes (1)

• Immediate Postoperative Pain Control

  We will be assessing if the intervention improves immediate (4 hours) postoperative pain control as compared to the non-intervention group. Measures that will be used to assess immediate post-operative pain include: Verbal pain scores, opioid consumption, and vital signs. Verbal pain scores were reported using the Wong-Baker FACES pain rating scale which ranges from 0 (no hurt) to 10 (hurts worst). Higher numerical scores on the scale indicate more pain, thus a worse outcome.

  4 hours post surgery

Secondary Outcomes (1)

• Pain Management Improvement at 24 Hours After the Recovery Period

  24 hours after the recovery period

Study Arms (2)

150% Oral Morphine Equivalent (OME)

EXPERIMENTAL

Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients

Drug: 150% Oral Morphine Equivalent (OME)

Control

ACTIVE COMPARATOR

Standard perioperative dosing, which does not currently account for patients' baseline opiate use.

Other: Clinical Judgment

Interventions

150% Oral Morphine Equivalent (OME) DRUG

Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl.

150% Oral Morphine Equivalent (OME)

Clinical Judgment OTHER

This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist.

Control

Eligibility Criteria

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

You may qualify if:

• Patients must be 18 years or older.
• Patients must be undergoing spine surgery at ANW.
• Patients must be assessed to be opioid tolerant based on the established criteria.
• Patients must be willing and able to provide written informed consent.

You may not qualify if:

• Patients unwilling to comply with research procedures.
• Patients having surgery for correction of scoliosis.

Sponsors & Collaborators

• Allina Health System: lead

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Pain; Chronic Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: John Mrachek, MD
• Organization: Allina Health

John.Mrachek@allina.com

612-871-7639

Study Officials

• John P Mrachek, MD

  Allina Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: October 6, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 27, 2020
• Results First Posted: April 27, 2020

Record last verified: 2020-04

Locations

US (1)