Predictors of Postoperative Pain

October 19, 2022 updated by: TriHealth Inc.

Predictors of Postoperative Pain in Urogynecologic Surgery

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

364

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) Pain Score
Time Frame: 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.
postoperative day 1 (POD1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Rachel Pauls, MD, TriHealth - Cincinnati Urogynecology Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (Estimated)

December 19, 2016

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

October 19, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 16-093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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