Multimodal Analgesia Versus Routine Care Pain Management (MMA)

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

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.

Study Overview

• Status: Terminated
• Conditions: Spinal Stenosis; Lumbar Spondylolisthesis; Degenerative Disc Disease Lumbar
• Intervention / Treatment: Other: Multimodal Analgesia; Other: Patient controlled analgesia

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center-Orthopedic Spine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal analgesia; 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; Subjects are given medications preop, intraop and postop that implement a multi-modal approach to managing pain.
Active Comparator: Patient Controlled analgesia; Pain management using patient controlled narcotic analgesia.	Other: Patient controlled analgesia; Subjects will be treated with patient controlled narcotic analgesia for pain management.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay		Post operatively (avg: 1-3 days)
Discharge destination	Determine whether patients are discharged to home or to another facility (e.g. rehab, etc)	Post operatively (avg:1-3 days)
Adverse events		Post operatively (avg: 1-3 days)
Disease specific and General health outcome measures	Short form 36 and the Oswestry Disabilty Index	Pre operatively (within 1 month of date of surgery) and Post operatively (6 weeks, 3months, 6 months, 1 year and 2 years)

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Frank M Phillips, MD, Rush University Medical Center

Publications and helpful links

General Publications

• Kim JC, Choi YS, Kim KN, Shim JK, Lee JY, Kwak YL. Effective dose of peri-operative oral pregabalin as an adjunct to multimodal analgesic regimen in lumbar spinal fusion surgery. Spine (Phila Pa 1976). 2011 Mar 15;36(6):428-33. doi: 10.1097/BRS.0b013e3181d26708.
• Rajpal S, Gordon DB, Pellino TA, Strayer AL, Brost D, Trost GR, Zdeblick TA, Resnick DK. Comparison of perioperative oral multimodal analgesia versus IV PCA for spine surgery. J Spinal Disord Tech. 2010 Apr;23(2):139-45. doi: 10.1097/BSD.0b013e3181cf07ee.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: May 8, 2013
• First Submitted That Met QC Criteria: May 21, 2013
• First Posted (Estimate): May 24, 2013

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Lumbar fusion; Multi-modal Pain Management; misTLIF
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: 13020402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED