Predictors of Postoperative Pain

Completed

• Conditions: Postoperative Pain

• Registration Number: NCT02996994
• Lead Sponsor: TriHealth Inc.

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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-15
• Study First Posted: 2016-12-19
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2022-10
• Results First Submitted: 2022-10-19
• Results First Submitted QC: 2022-10-19
• Last Update Submitted: 2022-10-19
• Results First Posted: 2023-08-31
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 364

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Pain Score	postoperative 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.