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

Carle Foundation

Status: Not yet enrolling

Conditions: Gynecologic Procedures; Patient Satisfaction; Pain Management

Treatments: Other: Pain Calculator

Study type: Interventional

Funder types: Other

Identifiers

NCT07311824

24CRU4052

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Pain Calculator

Experimental group

Description:

Participants will answer the Pain Calculator Questionnaire that will determine if they are low, moderate, or high risk for severe pain during their procedure. They will receive assigned pain medications based on their risk.

Treatment:

Other: Pain Calculator

Control

No Intervention group

Description:

Participants will have their pain management determined by the provider's best judgement, using shared decision making