NCT04130464 Intraperitoneal Infusion of Analgesic for Postoperative Pain Management
| NCT ID | NCT04130464 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ying Liu |
| Condition | Hysterectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2019-09-30 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2019-09-30 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 women undergoing minimally invasive hysterectomy receiving a continuous infusion of intraperitoneal (IP) local anesthetic (LA) or a continuous infusion of LA combined with an NSAID compared with a control group who receives only 0.9% normal saline.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Jennifer Keller, MD
PRINCIPAL INVESTIGATOR
Physician
Frequently Asked Questions
Who can join the NCT04130464 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Hysterectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04130464 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04130464 currently recruiting?
Yes, NCT04130464 is actively recruiting participants. Contact the research team at raly@mfa.gwu.edu for enrollment information.
Where is the NCT04130464 trial being conducted?
This trial is being conducted at Washington D.C., United States, Washington D.C., United States.
Who is sponsoring the NCT04130464 clinical trial?
NCT04130464 is sponsored by Ying Liu. The principal investigator is Jennifer Keller, MD at Physician. The trial plans to enroll 120 participants.