Intraperitoneal Infusion of Analgesic for Postoperative Pain Management

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: George Washington University
• Collaborator: Avanos Medical
• Treatments: Analgesics; Ketorolac; Ketorolac Tromethamine; Ropivacaine

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.