RECRUITING

Intraperitoneal Infusion of Analgesic for Postoperative Pain Management

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Conditions

HysterectomyGynecologic Surgical ProceduresNarcotic UsePain, PostoperativeIntraperitonealPain PumpRopivacaineKetorolac Tromethamine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-09-30
Study Completion:2024-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04130464

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.)
  2. * Patient is scheduled to have surgery with a fellowship trained minimally invasive gynecologic surgeons at one of the study sites.
  3. * Patient is planned for a robotic assisted total laparoscopic hysterectomy (RA-TLH) or a total laparoscopic hysterectomy (TLH).
  4. * Patient is capable of informed consent.
  5. * Patient is capable of completing the questionnaires.
  1. * Concern for malignancy
  2. * The procedure is scheduled outside MIGS department.
  3. * Allergy to any study related medication (i.e. Ketorolac and Ropivacaine)
  4. * Patient is enrolled in another pain management study.

Contacts and Locations

Study Contact

Radwa Aly
CONTACT
202 677 6209
raly@mfa.gwu.edu

Principal Investigator

Jennifer Keller, MD
PRINCIPAL_INVESTIGATOR
Physician

Study Locations (Sites)

MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
The GW Medical Faculty Associates
Washington, District of Columbia, 20037
United States

Collaborators and Investigators

Sponsor: Ying Liu

  • Jennifer Keller, MD, PRINCIPAL_INVESTIGATOR, Physician

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-30
Study Completion Date2024-09

Study Record Updates

Study Start Date2019-09-30
Study Completion Date2024-09

Terms related to this study

Keywords Provided by Researchers

  • Intraperitoneal
  • Pain Pump
  • Ropivacaine
  • Ketorolac Tromethamine

Additional Relevant MeSH Terms

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