Degenerative Disc Disease Lumbar, Lumbar Spondylolisthesis, Spinal Stenosis
Conditions
Keywords
Multi-modal Pain Management, Lumbar fusion, misTLIF
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.
Interventions
OTHERMultimodal Analgesia
Subjects are given medications preop, intraop and postop that implement a multi-modal approach to managing pain.
OTHERPatient controlled analgesia
Subjects will be treated with patient controlled narcotic analgesia for pain management.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | Post operatively (avg: 1-3 days) | — |
| Discharge destination | Post operatively (avg:1-3 days) | Determine whether patients are discharged to home or to another facility (e.g. rehab, etc) |
| Adverse events | Post operatively (avg: 1-3 days) | — |
| Disease specific and General health outcome measures | 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 |
Countries
United States
Outcome results
None listed