A Phase 4 interventional study of Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone in Pain, Postoperative, Spine Injuries and Disorders and Narcotic Use, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-11.
Sponsored by NYU Langone Health · Phase 4, Interventional, and Prevention
Among 13 studies in Pain, Postoperative by NYU Langone Health — 4 open to participants now, 5 under way, 1 of them phase 3. Pain, Postoperative · NYU Langone Health.
Among the 13 studies in Pain, Postoperative by NYU Langone Health, this one is the 6th largest by enrollment, is one of 2 that started in 2020, is one of 4 in phase 4, and was the 4th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 44 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →4 of the 13 studies in Pain, Postoperative by NYU Langone Health are open now, in 1 country. Each count lists the studies.
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 2 started in 2020.
Median enrollment 40 across the 13 interventional studies. Of the 6 that completed or were terminated, 5 (83%) have results posted.
NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Pain, Postoperative by NYU Langone Health, from their registry updates:
The aim of this study is to investigate the hypothesis that multimodal pain regimen (consisting of acetaminophen, celecoxib, gabapentin, and oxycodone) administered pre-operatively before elective spine surgery significantly decreases acute pain post-operatively as well as decreasing requirements of post-op opioids for pain control in PACU as compared to patients undergoing elective spine surgery without a pre-operative pain regimen.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone
The study subjects will be assigned to the defined pre-op MMA regimen with standard postop oxycodone based pain control regimen given on an as needed basis. The treatment group outcomes will be compared to patients outside of the study including a historical control group (receiving only post-op pain regimen) prior to the implementation of the new regimen. The studied treatment group will receive within 3 hours before surgery an oral MMA regimen consisting of: Acetaminophen 975 mg Celecoxib 200 mg Gabapentin 300 mg Oxycodone 10 mg Extended Release
Visual Analogue Scale (VAS) for Pain
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Time frame: 24 hours
Opioid Sparing and Rescue Time
Time interval from patient extubation to time when pain medication is first demanded in the PACU
Time frame: 24 hours
Length of Stay in Hospital
Time frame: Up to 12 days
| Milestone | Patients Undergoing Elective Spine Surgery |
|---|---|
| Started | 44 |
| Completed | 44 |
| Not completed | 0 |
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
| score on a scale | Patients Undergoing Elective Spine Surgery |
|---|---|
| Visual Analogue Scale (VAS) for Pain | 4.8 ± 2.6 |
Time interval from patient extubation to time when pain medication is first demanded in the PACU
| Hours | Patients Undergoing Elective Spine Surgery |
|---|---|
| Opioid Sparing and Rescue Time | 1.5 ± 2.2 |
| Hours | Patients Undergoing Elective Spine Surgery |
|---|---|
| Length of Stay in Hospital | 139 (7 to 270) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Undergoing Elective Spine Surgery | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
| Age, Continuous(years) | Patients Undergoing Elective Spine Surgery |
|---|---|
| Mean | 55.9 ± 10.7 |
| Sex: Female, Male(Participants) | Patients Undergoing Elective Spine Surgery |
|---|---|
| Female | 18 |
| Male | 26 |
| Ethnicity (NIH/OMB)(Participants) | Patients Undergoing Elective Spine Surgery |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 44 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Patients Undergoing Elective Spine Surgery |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 36 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Patients Undergoing Elective Spine Surgery |
|---|---|
| United States | 44 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication
Access criteria: Requests may be directed to the PI.
Ran from Aug 2020 to primary completion in Jun 2021, 9 months.
Results were first posted in Jul 2022, 1 year 1 month after primary completion.
Of 531 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's 9 months is below that.
Counting every sponsor, half of 541 studies reached it within 16 months; a quarter within 8 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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