Opioid Use, Postoperative Pain, Spinal Diseases, Surgery, Surgery--Complications
Conditions
Brief summary
Patients undergoing 1-3 level Anterior Cervical Discectomy and Fusion (ACDF) at the levels between C2 and T1 will be enrolled into this randomized prospective study. All patients enrolled in this study will undergo a trial of non-surgical treatment prior to the recommendation for surgery. After enrollment, patients will be randomized utilizing a block randomization strategy to one of two treatment groups - a standard opioid-containing postoperative pain regimen versus a non-opioid postoperative pain regimen. Postoperative outcomes will be assessed.
Detailed description
Patients will be followed for 12 months and the following Specific Aims will be assessed: Aim 1: Evaluate whether utilization of a non-opioid postoperative pain regimen after ACDF leads to lower rates of new chronic opioid use when compared with postoperative pain regimens utilizing opioids. Aim 2: Evaluate whether utilization of a non-opioid postoperative pain regimen after ACDF results in equivalent postoperative pain scores in the early postoperative period. Aim 3: Evaluate whether utilization of a non-opioid postoperative pain regimen after ACDF leads to equivalent clinical outcomes when compared with postoperative pain regimens utilizing opioids at 3 months and 12 months. Aim 4: Evaluate whether utilization of a non-opioid postoperative pain regimen after ACDF leads to fewer postoperative complications when compared with postoperative pain regimens utilizing opioids.
Interventions
DRUGOpioid Analgesic
Patients will be provided a prescription for low dose opioids for 5 days postoperatively (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) to be taken every 6 hours as needed for pain. Refills may be provided (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) if requested by the patient at the providers discretion. In addition, patients will also be prescribed Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily and a muscle relaxer (Methocarbamol 750mg BID or Flexeril 5-10 mg TID) as needed for spasms. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist.
DRUGOpioid-Free Postoperative Pain Regimen
Patients will receive no opioids. Pain will be managed with Acetaminophen 1000mg q8 hours, Ketorolac 10mg every 6 hours (for 5 days), Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily, and a muscle relaxer (Methocarbamol 750mg BID or Cyclobenzaprine 5-10 mg TID) all to be taken as scheduled for the first 2 weeks (except Ketorolac - 5 days) postoperatively as side effects permit. Other NSAIDS (Naprosyn 500 mg BID or Ibuprofen 800 mg TID) may be utilized if contraindications to Ketorolac exist. Famotidine (20mg BID) or Omeprazole (20mg daily) will be prescribed along with NSAIDS for GI prophylaxis. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist.
Sponsors
Cervical Spine Research Society
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, Non-Blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Radiographic evidence of degenerative cervical spine disease * Failure of conservative therapy * Age ≥18 years * Skeletal maturity.
Exclusion criteria
* Preoperative chronic opioid use as determined by self report (\>45 out of past 90 days) * History of chronic kidney disease * Revision cervical spine surgery * Concurrent posterior cervical fusion * Does the patient have an intolerance to NSAIDs (non-steroidal anti-inflammatory drugs)? * Does the patient have any preexisting health condition the study physician believes will be exacerbated by participating in this study?
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New Chronic Opioid Use | 9-12 months | Opioid prescription for \> or = 45 days in 90 day window (9-12 months postoperatively) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS-29 (Patient-Reported Outcomes Measurement Information System) | 3 and 12 months postoperatively | A disease non-specific tool for measuring medication management, depression, anxiety, fatigue, pain interference, sleep disturbance, and phsyical functioning. Each domain contains questions specific to what trait is being measure. Scores have a mean of 50 and a standard deviation of 10. The higher the score, the better the outcome. |
| Neck Disability Index (NDI) | 3 and 12 months postoperatively | — |
| Postoperative Pain | Postoperative day 1, 7, 14 | Numeric Rating Scale (NRS) arm pain and neck pain scores. This scale grades pain on a scale from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. The higher the pain score, the more ineffective a patient's pain medication regimen is. |
| Patient Satisfaction With the Surgical Outcome | 3 and 12 months postoperatively | Ask the patient how satisfied they are will their surgical treatment and includes the following responses. 1. Very satisfied 2. Somewhat satisfied 3. Neither satisfied nor dissatisfied 4. Somewhat dissatisfied 5. Very dissatisfied |
| Postoperative Adverse Events | Baseline to 12 months | Readmissions, adverse events, serious adverse events |
| Return to Work Status | 3 and 12 months postoperatively | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Perioperative Pain Regimen Opioid Analgesic: Patients will be provided a prescription for low dose opioids for 5 days postoperatively (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) to be taken every 6 hours as needed for pain. Refills may be provided (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) if requested by the patient at the providers discretion. In addition, patients will also be prescribed Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily and a muscle relaxer (Methocarbamol 750mg BID or Flexeril 5-10 mg TID) as needed for spasms. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist. | 5 |
| Opioid-Free Perioperative Pain Regimen Opioid-Free Postoperative Pain Regimen: Patients will receive no opioids. Pain will be managed with Acetaminophen 1000mg q8 hours, Ketorolac 10mg every 6 hours (for 5 days), Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily, and a muscle relaxer (Methocarbamol 750mg BID or Cyclobenzaprine 5-10 mg TID) all to be taken as scheduled for the first 2 weeks (except Ketorolac - 5 days) postoperatively as side effects permit. Other NSAIDS (Naprosyn 500 mg BID or Ibuprofen 800 mg TID) may be utilized if contraindications to Ketorolac exist. Famotidine (20mg BID) or Omeprazole (20mg daily) will be prescribed along with NSAIDS for GI prophylaxis. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist. | 3 |
| Total | 8 |
Baseline characteristics
| Characteristic | Opioid-Free Perioperative Pain Regimen | Total | Standard Perioperative Pain Regimen |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 6 Participants | 3 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 3 participants | 8 participants | 5 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 3 |
| other Total, other adverse events | 0 / 5 | 0 / 3 |
| serious Total, serious adverse events | 0 / 5 | 0 / 3 |
Outcome results
Primary
New Chronic Opioid Use
Opioid prescription for \> or = 45 days in 90 day window (9-12 months postoperatively)
Time frame: 9-12 months
Population: There is no data to analyze for this outcome, as patients were not contacted at the specified time point and no data was collected. Data was not collected due to early termination of the study.
Secondary
Neck Disability Index (NDI)
Time frame: 3 and 12 months postoperatively
Population: There is no data to analyze for this outcome, as patients were not contacted at the specified time point and no data was collected. Data was not collected due to early termination of the study.
Secondary
Patient Satisfaction With the Surgical Outcome
Ask the patient how satisfied they are will their surgical treatment and includes the following responses. 1. Very satisfied 2. Somewhat satisfied 3. Neither satisfied nor dissatisfied 4. Somewhat dissatisfied 5. Very dissatisfied
Time frame: 3 and 12 months postoperatively
Population: There is no data to analyze for this outcome, as patients were not contacted at the specified time point and no data was collected. Data was not collected due to early termination of the study.
Secondary
Postoperative Adverse Events
Readmissions, adverse events, serious adverse events
Time frame: Baseline to 12 months
Population: There is no data to analyze for this outcome, as patients were not contacted at the specified time point and no data was collected. Data was not collected due to early termination of the study.
Secondary
Postoperative Pain
Numeric Rating Scale (NRS) arm pain and neck pain scores. This scale grades pain on a scale from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. The higher the pain score, the more ineffective a patient's pain medication regimen is.
Time frame: Postoperative day 1, 7, 14
Population: One participant in the Standard Perioperative Pain Regimen group was lost to follow-up after randomization. One participant in the Opioid-Free Perioperative Pain Regimen group was lost to follow-up after randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Perioperative Pain Regimen | Postoperative Pain | Current Neck Pain Day 1 | 4.0 score on a scale | Standard Deviation 2.9 |
| Standard Perioperative Pain Regimen | Postoperative Pain | Current Neck Pain Day 7 | 4.2 score on a scale | Standard Deviation 2.4 |
| Standard Perioperative Pain Regimen | Postoperative Pain | Current Neck Pain Day 14 | 2.0 score on a scale | Standard Deviation 3.4 |
| Standard Perioperative Pain Regimen | Postoperative Pain | Average Neck Pain Day 1 | 5.5 score on a scale | Standard Deviation 4.1 |
| Standard Perioperative Pain Regimen | Postoperative Pain | Average Neck Pain Day 7 | 5.3 score on a scale | Standard Deviation 3.6 |
| Standard Perioperative Pain Regimen | Postoperative Pain | Average Neck Pain Day 14 | 3.8 score on a scale | Standard Deviation 3.3 |
| Standard Perioperative Pain Regimen | Postoperative Pain | Current Arm Pain Day 1 | 2.5 score on a scale | Standard Deviation 5 |
| Standard Perioperative Pain Regimen | Postoperative Pain | Current Arm Pain Day 7 | 1.8 score on a scale | Standard Deviation 3.5 |
| Standard Perioperative Pain Regimen | Postoperative Pain | Current Arm Pain Day 14 | 1.8 score on a scale | Standard Deviation 3.5 |
| Standard Perioperative Pain Regimen | Postoperative Pain | Average Arm Pain Day 1 | 0.5 score on a scale | Standard Deviation 0.7 |
| Standard Perioperative Pain Regimen | Postoperative Pain | Average Arm Pain Day 7 | 1.0 score on a scale | Standard Deviation 0 |
| Standard Perioperative Pain Regimen | Postoperative Pain | Average Arm Pain Day 14 | 2.5 score on a scale | Standard Deviation 0.7 |
| Opioid-Free Perioperative Pain Regimen | Postoperative Pain | Average Arm Pain Day 7 | 1.8 score on a scale | Standard Deviation 3.5 |
| Opioid-Free Perioperative Pain Regimen | Postoperative Pain | Current Neck Pain Day 1 | 1.5 score on a scale | Standard Deviation 0.7 |
| Opioid-Free Perioperative Pain Regimen | Postoperative Pain | Current Arm Pain Day 1 | 0.5 score on a scale | Standard Deviation 0.7 |
| Opioid-Free Perioperative Pain Regimen | Postoperative Pain | Current Neck Pain Day 7 | 0.0 score on a scale | Standard Deviation 0 |
| Opioid-Free Perioperative Pain Regimen | Postoperative Pain | Average Arm Pain Day 1 | 3.0 score on a scale | Standard Deviation 4.8 |
| Opioid-Free Perioperative Pain Regimen | Postoperative Pain | Current Neck Pain Day 14 | 4.0 score on a scale | — |
| Opioid-Free Perioperative Pain Regimen | Postoperative Pain | Current Arm Pain Day 7 | 1.5 score on a scale | Standard Deviation 0.7 |
| Opioid-Free Perioperative Pain Regimen | Postoperative Pain | Average Neck Pain Day 1 | 1.5 score on a scale | Standard Deviation 0.7 |
| Opioid-Free Perioperative Pain Regimen | Postoperative Pain | Average Arm Pain Day 14 | 2.0 score on a scale | Standard Deviation 4 |
| Opioid-Free Perioperative Pain Regimen | Postoperative Pain | Average Neck Pain Day 7 | 0.0 score on a scale | Standard Deviation 0 |
| Opioid-Free Perioperative Pain Regimen | Postoperative Pain | Current Arm Pain Day 14 | 3.0 score on a scale | Standard Deviation 1.4 |
| Opioid-Free Perioperative Pain Regimen | Postoperative Pain | Average Neck Pain Day 14 | 1.5 score on a scale | Standard Deviation 2.1 |
Secondary
PROMIS-29 (Patient-Reported Outcomes Measurement Information System)
A disease non-specific tool for measuring medication management, depression, anxiety, fatigue, pain interference, sleep disturbance, and phsyical functioning. Each domain contains questions specific to what trait is being measure. Scores have a mean of 50 and a standard deviation of 10. The higher the score, the better the outcome.
Time frame: 3 and 12 months postoperatively
Population: There is no data to analyze for this outcome, as patients were not contacted at the specified time point and no data was collected. Data was not collected due to early termination of the study.
Secondary
Return to Work Status
Time frame: 3 and 12 months postoperatively
Population: There is no data to analyze for this outcome, as patients were not contacted at the specified time point and no data was collected. Data was not collected due to early termination of the study.