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This study aims to compare the effects of intrathecal morphine to traditional pain management strategies on post-operative recovery for deformity surgery.
Background Deformity surgery is considered one of the most painful procedures patients can undergo in medicine today. Stringent protocols for pain management have done much to dramatically increase patient satisfaction, but the procedure still lags considerably behind advances in pain control when compared to other procedures such as total joint surgery. Specifically, it has been reported that over half of patients undergoing spine surgery report inadequate pain control the first 24 hours after surgery. Uncontrolled pain has been shown to correlate with prolonged hospital stays, delayed ambulation, poor functional outcomes, and increased risk for the development of chronic pain. Furthermore, the large amount of narcotics given to patients in an attempt to mitigate their pain postoperatively often leads to significant complications in their own right, such as ileus, mental status changes, and nausea. New modalities to treat postoperative pain, especially in the initial days following deformity correction, are needed.
Intrathecal (subarachnoid) injection of morphine has been used to treat severe pain since the 1970's. Its efficacy in treating postoperative pain has been well documented in various specialties including obstetrics, oncology, general surgery, and orthopedic surgery. Specific to spine surgery, intrathecal morphine is an attractive option given the access and visualization of the thecal sac in addition to the high demand of pain control required postoperatively. However, there remains no definitive consensus regarding the use of intrathecal morphine in spine surgery. Current literature is limited by few randomized trials, small sample sizes, heterogeneity of outcomes recorded, and an unclear association with complications. Additionally, there is a paucity of data dedicated to patients undergoing deformity correction. Accordingly, there is a need for high-quality trials to investigate the role of intrathecal morphine in adult spinal deformity surgery.
In this study, we hypothesized that the use of intrathecal morphine will significantly reduce post-operative pain after deformity surgery, reduce opioid utilization, decrease hospital stay, allow for earlier ambulation, increase patient satisfaction, and have comparable complications to traditional pain management strategies. This study aims to compare the effects of intrathecal morphine to traditional pain management strategies on post-operative recovery for deformity surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Active Comparator | Patients in this group will receive intrathecal morphine in addition to standard post-operative pain medications |
|
| Control Group | Active Comparator | Patients in this group will receive standard post-operative pain medications but will not receive intrathecal morphine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal Morphine Injection | Drug | In addition to standard post-operative pain management, Intratechal morphine will be given to patients in this group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain and Outcome Assessment | postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain Oswesty Disability Index and Scoliosis Research Society Questionnaire | preoperative |
| Pain and Outcome Assessment | postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain | 6 week, post operative |
| Pain and Outcome Assessment | postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain | 3 months post operative |
| Pain and Outcome Assessment | postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain | 1 year post operative |
| Pain and Outcome Assessment | postoperative pain using Numerical pain score 0 no pain - 10 severe intolerable pain | 2-year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Pain medications | Types of pain medication (Narcotics or Non-Narcotics) | Preoperative |
| Pain medications | Types of pain medication (Narcotics or Non-Narcotics) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Biodun Adeniyi, MBBS, MS | Contact | 4805973138 | biodun@sonoranspine.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael S Chang, MD | Sonoran Spine Research and Education Foundation | Principal Investigator |
| Andrew Chung, DO | Sonoran Spine Research and Education Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonoran Spine in Collaboration with HonorHealth | Recruiting | Tempe | Arizona | 85281 | United States |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000698 | Analgesia |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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Nursing staff and physical therapists will be blinded to intrathecal morphine utilization as to not bias the input of these variables
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| Pain Relieving | Drug | Patient in this group will receive standard postoperative pain medications other than inthrathecal injection of morphine |
|
|
| 6 weeks Post Operative |
| Pain medications | Types of pain medication (Narcotics or Non-Narcotics) | 3 months Post Operative |
| Pain medications | Types of pain medication (Narcotics or Non-Narcotics) | 1 year Post Operative |
| Pain medications | Types of pain medication (Narcotics or Non-Narcotics) | 2 year Post Operative |
| Sonoran Spine | Not yet recruiting | Tempe | Arizona | 85281 | United States |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |