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Intraperitoneal Infusion of Analgesic for Postoperative Pain Management

RecruitingPhase 4Ages 18 Years - 65 YearsFemaleYing Liu
NCT04130464 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Ropivacaine Infusion from ON-Q Pump
  • Ropivacaine + Ketorolac Infusion from ON-Q Pump
  • Normal Saline Infusion from ON-Q Pump
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Where

2 sites
MedStar Washington Hospital Center
Washington D.C., United States
The GW Medical Faculty Associates
Washington D.C., United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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