Multimodal Analgesia Versus Routine Care Pain Management

Study Overview
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Brief Summary
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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
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We hypothesize patients undergoing spinal fusion who receive peri-operative MMA will have: decreased post-operative pain compared to patients receiving usual care for pain management. shorter hospital LOS compared to patients receiving usual care pain management. fewer analgesic-related post-operative complications (urinary retention, ileus, etc) compared to patients receiving usual care pain management. improved physical functioning at the time of hospital discharge compared to patients receiving usual care pain management. 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.

Official Title
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Multimodal Analgesia Versus Routine Care Pain Management for Minimally Invasive Spine Surgery: A Prospective Randomized Study

Conditions
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Degenerative Disc Disease Lumbar, Spinal Stenosis, Lumbar Spondylolisthesis

Intervention / Treatment
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* Other: Multimodal Analgesia
* Other: Patient controlled analgesia


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimodal analgesia<br>multiple analgesic medications utilized in a synergistic manner to control pain while minimizing side-effects of individual drugs due to decreased doses. This includes pre-operative patient education, intra-operative pain management and post-operative pain protocols. | Other: Multimodal Analgesia<br>* Subjects are given medications preop, intraop and postop that implement a multi-modal approach to managing pain.<br>|
| Active Comparator: Patient Controlled analgesia<br>Pain management using patient controlled narcotic analgesia. | Other: Patient controlled analgesia<br>* Subjects will be treated with patient controlled narcotic analgesia for pain management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric pain scale | (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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | At each pain assessment (minimum every 4 hours), partients are asked if they are satisfied with their pain management. (yes/no) | Post operatively (avg: 1-3 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multi-modal Pain Management, Lumbar fusion, misTLIF