Multimodal Analgesia Versus Routine Care Pain Management for Minimally Invasive Spine Surgery: A Prospective Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease Lumbar
- Sponsor
- Rush University Medical Center
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Numeric pain scale
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
Most patients undergoing surgery experience significant post-operative pain. Inadequate peri-operative pain management may decrease post-operative mobilization and increase length of hospitalization. Additionally, poorly managed acute post-operative pain analgesia is associated with an increased risk of developing chronic pain and delayed wound healing.
Lumbar spine surgery is particularly painful, often requiring a multi-day hospitalization. The most common post-operative analgesia used in spine surgery is narcotic medication delivered via an intravenous patient controlled analgesia (IV PCA).
A multimodal peri-operative pain management protocol for spine surgery has the potential to not only decrease pain but also to improve recovery, decrease narcotic consumption, decrease length of stay in the hospital and reduce both direct and indirect hospital costs.
The purpose of this study is to determine if post-operative pain and rate of recovery are improved in patients undergoing spine surgery using MMA compared to usual analgesic care.
Detailed Description
We hypothesize patients undergoing spinal fusion who receive peri-operative MMA will have: 1. decreased post-operative pain compared to patients receiving usual care for pain management. 2. shorter hospital LOS compared to patients receiving usual care pain management. 3. fewer analgesic-related post-operative complications (urinary retention, ileus, etc) compared to patients receiving usual care pain management. 4. improved physical functioning at the time of hospital discharge compared to patients receiving usual care pain management. 5. better short and long term outcomes. Subjects will be randomized to MMA (Group 1) or usual care (Group 2). The unit of randomization will be a week (Monday through Sunday). Each week will randomly be assigned to MMA or usual care. Subjects who are hospitalized into a consecutive week will continue with the pain regimen they were assigned upon hospitalization.
Investigators
Frank M. Phillips, MD
MD
Rush University Medical Center
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing single level MIS-TLIF
- •Patients able to provide informed consent
Exclusion Criteria
- •Allergies or other contraindications to medicines in the protocol
- •Current liver disease with documented liver function test abnormality
- •Current renal disese with documented glomerular filtration rate (GFR) \< 60 mL/min/1.73m2
- •Baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day
- •Active alcohol dependence
- •Active illicit drug dependence
Outcomes
Primary Outcomes
Numeric pain scale
Time Frame: Patients will be followed post-operatively while in the hospital (Avg 1-3 days), and a 6 weeks, 3 months, 6 months, 1 year and 2 years.
(a) While in the hospital, patients' pain is assessed by a nurse-driven protocol. Assessments are every four to six hours, within 60 minutes after receiving an intravenous pain medication and within 90 minutes of receiving an oral pain medication. This assessment includes rating subjective rating of ones pain on a verbal numeric rating scale (NRS) of 0-10. The maximum pain score for each post-operative day will be compared.
Secondary Outcomes
- Patient satisfaction(Post operatively (avg: 1-3 days))