The Impact of the Continuous Infusion of Intraperitoneal Analgesics on Postoperative Pain After Minimally Invasive Hysterectomy: a Randomized Controlled Trial
Ying Liu
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.
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 of participation will be explained to them. If they choose to participate they will sign the consent form at that time or if they need more time to consider participation they will sign later. They will then complete the health-related quality of life (HrQoL) questionnaire UFS-QOL\* before surgery. * Computer-generated randomization will be used to randomize patients between 3 groups: * Group A: re…
Eligibility
- Age range
- 18–65 years
- Sex
- Female
- Healthy volunteers
- Yes
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. * Patien…
Interventions
- DrugRopivacaine Infusion from ON-Q Pump
Infusion of 0.2% ropivacaine at 8 mL/hour for 72 hours
- DrugRopivacaine + Ketorolac Infusion from ON-Q Pump
Infusion of 0.2% ropivacaine + 30 mg ketorolac at 8 mL/hour for 72 hours
- DrugNormal Saline Infusion from ON-Q Pump
Infusion of 0.9% normal saline at 8 mL/hour for 72 hours
Locations (2)
- MedStar Washington Hospital CenterWashington D.C., District of Columbia
- The GW Medical Faculty AssociatesWashington D.C., District of Columbia