An observational study in Postoperative Pain, sponsored by TriHealth Inc.. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-31.
Sponsored by TriHealth Inc. · Observational
This is a retrospective chart review using TriHealth Electronic Privacy Identification Center (EPIC) and previously developed databases for TriHealth Institutional Review Board (IRB) approved research studies within the Division of Urogynecology and Reconstructive Pelvic Surgery to determine the predictors of postoperative pain specific to the urogynecologic patient population.
Postoperative pain remains the most important consideration for both patients and surgeons. Therefore, there has been much attention brought toward investigating predictive factors of postoperative pain. A systematic review of 48 eligible studies with 23,037 patients showed preexisting pain, anxiety, age, and type of surgery are the four most significant predictive factors for the intensity of postoperative pain. However, this paper evaluated all types of surgical approaches. More recently, a prospective observational study showed that preoperative State Trait Anxiety Inventory (STAI) and Numerical Rating Scales (NRS) for anxiety and pain expectations are independent predictors of pain and morphine consumption following abdominal hysterectomy. To date, little is known about the predictive factors of postoperative pain in the urogynecologic patient population.
The purpose of this study is to determine the predictors of postoperative pain specific to the urogynecologic patient population. We aim to investigate the relationship between perioperative factors (such as demographics and medical history) and postoperative pain scores on postoperative day 1 with patients who have undergone urogynecologic surgery, specifically vaginal reconstruction for pelvic organ prolapse.
This information would not only fill a gap in knowledge, but would also allow us to counsel our patients more accurately in regards to postoperative expectations. Furthermore, if we find any positive correlation between modifiable perioperative factors and postoperative pain scores, we may be able to minimize these effects in future surgical cases.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 364 is above the median of 102 across 608 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →TriHealth Inc. is the lead sponsor of 99 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
All participants of previous TriHealth IRB-approved research studies within the Division of Urogynecology and Reconstructive Pelvic Surgery that incorporated assessment of postoperative pain as part of the data collection
Exclusion Criteria:
Visual Analog Scale (VAS) Pain Score
VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects drew a vertical line on the scale corresponding to their pain level.
Time frame: postoperative day 1 (POD1)
| Milestone | Reconstructive Surgery |
|---|---|
| Started | 364 |
| Completed | 364 |
| Not completed | 0 |
VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects drew a vertical line on the scale corresponding to their pain level.
| mm | Reconstructive Surgery |
|---|---|
| Visual Analog Scale (VAS) Pain Score | 38.16 ± 24.89 |
Collected over From time of surgery to 12 weeks after surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reconstructive Surgery | 0/364 (0%) | 0/364 (0%) | 0/364 (0%) |
| Age, Continuous(years) | Reconstructive Surgery |
|---|---|
| Mean | 59.44 ± 11.42 |
| Sex: Female, Male(Participants) | Reconstructive Surgery |
|---|---|
| Female | 364 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Reconstructive Surgery |
|---|---|
| Caucasian | 351 |
| African American | 9 |
| Asian | 2 |
| Other | 1 |
| Missing | 1 |
| Region of Enrollment(participants) | Reconstructive Surgery |
|---|---|
| United States | 364 |
No study locations are listed for this record.
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Plan to share: No
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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