Predictors of Postoperative Pain

NCT02996994 | Completed Results

• 1 other identifier: 16-093
• Study Type: observational
• Target: 364
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  postoperative day 1 (POD1)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• TriHealth Inc.: lead

Related Publications (3)

• 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.

  PMID: 19672167 BACKGROUND

• 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.

  PMID: 26499321 BACKGROUND

• 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.

  PMID: 29474293 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Rachel Pauls
• Organization: TriHealth Inc.

Rachel_Pauls@trihealth.com

513-463-4300

Study Officials

• Rachel Pauls, MD

  TriHealth - Cincinnati Urogynecology Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 19, 2016
• Study Start: December 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 31, 2023
• Results First Posted: August 31, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share