Multimodal Analgesia Versus Routine Care Pain Management
| Status: | Terminated |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/31/2018 |
| Start Date: | April 2013 |
| End Date: | December 2017 |
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
