Intraperitoneal Infusion of Analgesic for Postoperative Pain Management

Description

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.

Conditions

Hysterectomy, Gynecologic Surgical Procedures, Narcotic Use, Pain, Postoperative

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Study Overview

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Study Details

Study overview

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.

The Impact of the Continuous Infusion of Intraperitoneal Analgesics on Postoperative Pain After Minimally Invasive Hysterectomy: a Randomized Controlled Trial

Intraperitoneal Infusion of Analgesic for Postoperative Pain Management

Condition
Hysterectomy
Intervention / Treatment

-

Contacts and Locations

Washington

MedStar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Washington

The GW Medical Faculty Associates, Washington, District of Columbia, United States, 20037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Ying Liu,

Jennifer Keller, MD, PRINCIPAL_INVESTIGATOR, Physician

Study Record Dates

2024-09