Status:
COMPLETED
Novel Multimodal Pain Control Protocol for Minimally Invasive Gynecologic Surgery
Lead Sponsor:
Ohio State University
Conditions:
Postoperative Pain
Narcotic Use
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The study is a randomized controlled trial investigating a multimodal postoperative pain management protocol which will include use of ice therapy and scheduled opioid-sparing medications for pain con...
Detailed Description
The study is a randomized controlled trial investigating a multimodal postoperative pain management protocol which will include use of ice therapy and scheduled opioid-sparing medications for pain con...
Eligibility Criteria
Inclusion
- Minimally invasive (laparoscopic or robotic) major gynecologic procedures including: pelvic floor procedures (uterosacral ligament suspension, sacrocolpopexy, Burch colposuspension) with or without concomitant hysterectomy, adnexal surgery, or vaginal surgery; total or supracervical hysterectomy with or without concomitant adnexal surgery, vaginal surgery, or other minor gynecologic procedures
- Patients admitted to the hospital for at least an overnight observation after their surgery
- English-speaking
- Surgery being performed by one of the five attending surgeons included in study
Exclusion
- Pregnancy. If patient is of childbearing potential and not using contraception a urine pregnancy test will be completed as part of standard practice as part of pre-operative labs.
- Diagnosis of chronic pelvic pain. Documented pelvic pain noted to be of \>6 months duration.
- Diagnosis or history of chronic opioid use. Defined as use of opioids most days, for more than 3 months.
- Diagnosis or history of opioid abuse disorder.
- Current daily opioid use.
- Liver, renal, or cardiac disease that is/are a contraindication to any medications used in the study.
- Allergy or intolerance to any medication used in the study (with exception of oxycodone which can be substituted for hydromorphone if necessary).
- Dementia or inability to understand or respond to the study measurement tools.
- Intraoperative exclusion criteria (to be reviewed after surgery is complete): conversion to total vaginal procedure or laparotomy, major intraoperative complications that would deem participant inappropriate for trial (hemorrhage, blood transfusion, conversion to laparotomy, bowel surgery, major urologic procedures including bladder or ureteral repair).
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04710277
Start Date
April 19 2021
End Date
October 20 2022
Last Update
May 12 2023
Active Locations (1)
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1
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210