Status:
UNKNOWN
Intraperitoneal Infusion of Analgesic for Postoperative Pain Management
Lead Sponsor:
Ying Liu
Collaborating Sponsors:
Avanos Medical
Conditions:
Hysterectomy
Gynecologic Surgical Procedures
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief Summary
The study is a prospective, double-blinded, placebo-controlled multi-center trial to measure if postoperative pain and the amount of narcotics used are reduced by a clinically significant amount in wo...
Detailed Description
* Any patient desiring minimally invasive hysterectomy will be contacted by a study team member during their visit to the MIGS (minimally invasive gynecologic surgery) clinic. The risks and benefits o...
Eligibility Criteria
Inclusion
- Hysterectomy planned for a benign gynecologic reason (no evidence of, or concern for, malignancy in the cervix, uterus, tubes or ovaries. Benign gynecologic reasons to have a hysterectomy include fibroids, abnormal uterine bleeding, endometriosis, and pelvic pain.)
- Patient is scheduled to have surgery with a fellowship trained minimally invasive gynecologic surgeons at one of the study sites.
- Patient is planned for a robotic assisted total laparoscopic hysterectomy (RA-TLH) or a total laparoscopic hysterectomy (TLH).
- Patient is capable of informed consent.
- Patient is capable of completing the questionnaires.
Exclusion
- Concern for malignancy
- The procedure is scheduled outside MIGS department.
- Allergy to any study related medication (i.e. Ketorolac and Ropivacaine)
- Patient is enrolled in another pain management study.
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04130464
Start Date
September 30 2019
End Date
September 1 2024
Last Update
November 8 2023
Active Locations (2)
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1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
The GW Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037