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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.
We hypothesize patients undergoing spinal fusion who receive peri-operative MMA will have:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal analgesia | Experimental | 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. |
|
| Patient Controlled analgesia | Active Comparator | Pain management using patient controlled narcotic analgesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal Analgesia | Other | Subjects are given medications preop, intraop and postop that implement a multi-modal approach to managing pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric pain scale | (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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | At each pain assessment (minimum every 4 hours), partients are asked if they are satisfied with their pain management. (yes/no) | Post operatively (avg: 1-3 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Post operatively (avg: 1-3 days) | |
| Discharge destination | Determine whether patients are discharged to home or to another facility (e.g. rehab, etc) | Post operatively (avg:1-3 days) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank M Phillips, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center-Orthopedic Spine | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21372654 | Result | Kim JC, Choi YS, Kim KN, Shim JK, Lee JY, Kwak YL. Effective dose of peri-operative oral pregabalin as an adjunct to multimodal analgesic regimen in lumbar spinal fusion surgery. Spine (Phila Pa 1976). 2011 Mar 15;36(6):428-33. doi: 10.1097/BRS.0b013e3181d26708. | |
| 20375829 | Result | Rajpal S, Gordon DB, Pellino TA, Strayer AL, Brost D, Trost GR, Zdeblick TA, Resnick DK. Comparison of perioperative oral multimodal analgesia versus IV PCA for spine surgery. J Spinal Disord Tech. 2010 Apr;23(2):139-45. doi: 10.1097/BSD.0b013e3181cf07ee. |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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| ID | Term |
|---|---|
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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| Patient controlled analgesia | Other | Subjects will be treated with patient controlled narcotic analgesia for pain management. |
|
| Adverse events | Post operatively (avg: 1-3 days) |
| Disease specific and General health outcome measures | Short form 36 and the Oswestry Disabilty Index | Pre operatively (within 1 month of date of surgery) and Post operatively (6 weeks, 3months, 6 months, 1 year and 2 years) |
| D055009 |
| Spondylosis |