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Predictors of Postoperative Pain

Predictors of Postoperative Pain in Urogynecologic Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02996994
Enrollment
364
Registered
2016-12-19
Start date
2016-12-31
Completion date
2017-10-31
Last updated
2023-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

TriHealth Inc.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participant in one of six research studies previously performed by the Division of Urogynecology and Pelvic Reconstructive Surgery (#13090, #13072, #12136, #12132, #10072, or #09001) * Postoperative pain scoring data complete and available * Vaginal reconstructive surgery as primary treatment * General anesthesia

Exclusion criteria

* Incomplete or unavailable postoperative pain scoring * Robotic sacrocolpopexy patients will be excluded

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale (VAS) Pain Scorepostoperative day 1 (POD1)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.

Participant flow

Participants by arm

ArmCount
Reconstructive Surgery
Eligible trials enrolled subjects undergoing vaginal reconstructive surgery for pelvic organ prolapse from 2009 to 2015.
364
Total364

Baseline characteristics

CharacteristicReconstructive Surgery
Age, Continuous59.44 years
STANDARD_DEVIATION 11.42
Race/Ethnicity, Customized
African American
9 Participants
Race/Ethnicity, Customized
Asian
2 Participants
Race/Ethnicity, Customized
Caucasian
351 Participants
Race/Ethnicity, Customized
Missing
1 Participants
Race/Ethnicity, Customized
Other
1 Participants
Region of Enrollment
United States
364 participants
Sex: Female, Male
Female
364 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 364
other
Total, other adverse events
0 / 364
serious
Total, serious adverse events
0 / 364

Outcome results

Primary

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)

ArmMeasureValue (MEAN)Dispersion
Reconstructive SurgeryVisual Analog Scale (VAS) Pain Score38.16 mmStandard Deviation 24.89

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026