NCT01861743

Multimodal Analgesia Versus Routine Care Pain Management

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Degenerative Disc Disease Lumbar
• Spinal Stenosis
• Lumbar Spondylolisthesis

Interventions

Type	Name	Description
OTHER	Multimodal Analgesia	Subjects are given medications preop, intraop and postop that implement a multi-modal approach to managing pain.
OTHER	Patient controlled analgesia	Subjects will be treated with patient controlled narcotic analgesia for pain management.

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-12-31
• Completion: 2017-12-01
• First posted: 2013-05-24
• Last updated: 2018-08-29

Locations

1 site across 1 country: United States