Clinical trial NCT02996994: Predictors of Postoperative Pain
Official title: Predictors of Postoperative Pain in Urogynecologic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 364
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale (VAS) Pain Score
timeFrame: postoperative day 1 (POD1)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: TriHealth - Cincinnati Urogynecology Associates
name: Rachel Pauls, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
citation: Aouad MT, Kanazi GE, Malek K, Tamim H, Zahreddine L, Kaddoum RN. Predictors of postoperative pain and analgesic requirements following abdominal hysterectomy: an observational study. J Anesth. 2016 Feb;30(1):72-9. doi: 10.1007/s00540-015-2090-0. Epub 2015 Oct 24.
citation: Shatkin-Margolis A, Crisp CC, Morrison C, Pauls RN. Predicting Pain Levels Following Vaginal Reconstructive Surgery: Who Is at Highest Risk? Female Pelvic Med Reconstr Surg. 2018 Mar/Apr;24(2):172-175. doi: 10.1097/SPV.0000000000000522.