Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

Opioid Use Clinical Trial

Official title:

Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05571072
• Other study ID #: STUDY20221287
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: January 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the investigators can precisely predict how much pain medication the subjects will need after surgery using a special calculator that was developed for this purpose.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Age 18-89
• Able to provide informed consent
• Patients undergoing any of below urogynecologic procedures

Included urogynecologic procedures:

1. Sacrocolpopexy - robotic or laparoscopic

1. With or without hysterectomy

2. With or without salpingo-oophorectomy

3. With or without anterior colporrhaphy

4. With or without posterior colporrhaphy/perineorrhaphy

5. With or without midurethral sling

2. Sacrospinous ligament fixation

1. With or without hysterectomy

2. With or without salpingo-oophorectomy

3. With or without anterior colporrhaphy

4. With or without posterior colporrhaphy/perineorrhaphy

5. With or without midurethral sling

3. Uterosacral ligament suspension - robotic, laparoscopic, or vaginal

1. With or without hysterectomy

2. With or without salpingo-oophorectomy

3. With or without anterior colporrhaphy

4. With or without posterior colporrhaphy/perineorrhaphy

5. With or without midurethral sling

4. Colpocleisis

1. Lefort colpocleisis

2. Complete colpectomy with colpocleisis

5. Isolated anterior and/or posterior colporrhaphy

Exclusion Criteria:

• Non-English speakers
• pre-operative diagnosis of cancer
• scheduled for any concurrent non-urogynecologic procedure (ex: abdominoplasty)
• <18 years or >89 years of age
• unable to provide informed consent

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative
• Post Operative Pain
• Prolapse
• Prolapse Genital

Intervention

Other:
• Opioid calculator
Our research group previously created an Opioid calculator that can be used to predict the number of opioids needed post-operatively based on patient health history and characteristics.
• Standard opioid prescription
Patients will receive prescription for post-operative opioids based on what the attending surgeon usually provides.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
David Sheyn

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain scores measured by team-created pain questionnaires	Pain questionnaire is a 2 question survey that ask patients to rate pain on scale of 0 (no pain) to 10 (worst pain) immediately post-op and current. Baseline will be calculated by asking patient's expected post-op pain score.	baseline, 1 week post-op, 2 weeks post-op
Secondary	Change in satisfaction scores measured by team-created questionnaire	Questionnaire is a 1 question survey that ask patients to rate their satisfaction with their pain control on scale of 0 (totally unsatisfied) to 10 (totally satisfied) immediately post-op and current.	1 week post-op, 2 weeks post-op
Secondary	Change in number of opioid tablets remaining measured by team-created questionnaire	Patients will be asked the number of tablets remaining from their opioid prescriptions.	1 week post-op, 2 weeks post-op