Pain Management for In-Office Gynecologic Procedures Using a Risk-Stratification Pain Calculator

ClinicalTrials.gov ID

NCT07311824

Lead Sponsor

Carle Foundation HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

200Estimated

Last Update Posted

Dec 31, 2025Actual

Start Date

Dec 29, 2025Estimated

Primary Completion Date

Feb 28, 2027Estimated

Completion Date

Apr 30, 2027Estimated

Official Title

Pain Management Optimization for In-Office Gynecologic Procedures: The Development and Evaluation of a Risk-Stratification Pain Calculator

Brief Summary

The goal of this clinical trial is to learn how using a risk-stratification calculator to determine the risk of a patient experiencing severe pain during an in-office gynecologic procedure and subsequently assigning pain medications to be used for the procedure based on risk, will affect patients' pain during these procedures. The main questions it aims to answer are:

• Does using pain medications determined by a risk-stratification calculator improve patients' pain scores during if-office gynecologic procedures?
• Does using pain medications determined by a risk-stratification calculator improve patient satisfaction?

Researchers will compare using the risk-stratification calculator to decide on pain medications to a provider using their best judgement to decide on pain medications. This will help determine if patients have improved pain scores and satisfaction if they have their pain medications assigned using the risk-stratification calculator.

Participants who are undergoing a relevant in-office gynecologic procedure will:

• Receive pain medications for their procedure either based on their answers to questions for the risk-stratification calculator or based on their provider's best judgement.
• Answer an online survey about their experience with the procedure and related pain management.

• Pain Management
• Patient Satisfaction
• Gynecologic Procedures

• Pain Calculator

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• At least 18 years of age
• Proficient in English
• Access to personal smart devices (smartphone, tablet, laptop, etc.)
• Will be undergoing the following in-office gynecologic procedures: IUD insertion, endometrial biopsy, colposcopy with cervical biopsy, or hysteroscopy

Exclusion Criteria:

• Under the age of 18
• Non-English-Speaking
• Have contraindications to taking NSAIDs, acetaminophen, lidocaine or its derivatives, or opioids
• Patients who are taking methadone, Suboxone, and/or naltrexone

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Carle Foundation HospitalOTHER

claire.aucoin@carle.com217-383-3140 ext. 3

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