Multimodal Analgesia Versus Routine Care Pain Management

Not Applicable

Terminated

• Conditions: Degenerative Disc Disease Lumbar; Spinal Stenosis; Lumbar Spondylolisthesis
• Interventions: Other: Patient controlled analgesia; Other: Multimodal Analgesia

• Registration Number: NCT01861743
• Lead Sponsor: Rush University Medical Center

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-08
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-24
• Primary Completion: 2016-12-31
• Study Completion: 2017-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Controlled analgesia	Patient controlled analgesia	Pain management using patient controlled narcotic analgesia.
Multimodal analgesia	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.

Primary Outcome Measures

Name	Time	Method
Numeric pain scale	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 Outcome Measures

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

Trial Locations

Locations (1)

Rush University Medical Center-Orthopedic Spine; 🇺🇸 Chicago, Illinois, United States