Multimodal Analgesia Versus Routine Care Pain Management (MMA)
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|ClinicalTrials.gov Identifier: NCT01861743|
Recruitment Status : Terminated (data was not collected accurately)
First Posted : May 24, 2013
Last Update Posted : August 29, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease Lumbar Spinal Stenosis Lumbar Spondylolisthesis||Other: Multimodal Analgesia Other: Patient controlled analgesia||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Multimodal Analgesia Versus Routine Care Pain Management for Minimally Invasive Spine Surgery: A Prospective Randomized Study|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||December 2017|
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.
- 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.
- Patient satisfaction [ Time Frame: 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)
- Length of Stay [ Time Frame: Post operatively (avg: 1-3 days) ]
- Discharge destination [ Time Frame: Post operatively (avg:1-3 days) ]Determine whether patients are discharged to home or to another facility (e.g. rehab, etc)
- Adverse events [ Time Frame: Post operatively (avg: 1-3 days) ]
- Disease specific and General health outcome measures [ Time Frame: Pre operatively (within 1 month of date of surgery) and Post operatively (6 weeks, 3months, 6 months, 1 year and 2 years) ]Short form 36 and the Oswestry Disabilty Index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861743
|United States, Illinois|
|Rush University Medical Center-Orthopedic Spine|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Frank M Phillips, MD||Rush University Medical Center|