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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05571072
Other study ID # STUDY20221287
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2, 2023
Est. completion date February 17, 2024

Study information

Verified date June 2024
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
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 Completed
Enrollment 110
Est. completion date February 17, 2024
Est. primary completion date February 17, 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

Study Design


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
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