Intraperitoneal Infusion of Analgesic for Postoperative Pain Management
The Impact of the Continuous Infusion of Intraperitoneal Analgesics on Postoperative Pain After Minimally Invasive Hysterectomy: a Randomized Controlled Trial
Ying Liu
120 participants
Sep 30, 2019
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria4
- 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.
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Interventions
Infusion of 0.2% ropivacaine at 8 mL/hour for 72 hours
Infusion of 0.2% ropivacaine + 30 mg ketorolac at 8 mL/hour for 72 hours
Infusion of 0.9% normal saline at 8 mL/hour for 72 hours
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT04130464