Intraperitoneal Infusion of Analgesic for Postoperative Pain Management
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorYing Liu
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ropivacaine Infusion from ON-Q Pump
- Ropivacaine + Ketorolac Infusion from ON-Q Pump
- Normal Saline Infusion from ON-Q Pump
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov