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Intraperitoneal Infusion of Analgesic for Postoperative Pain Management (ON-Q)

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ClinicalTrials.gov Identifier: NCT04130464
Recruitment Status : Recruiting
First Posted : October 17, 2019
Last Update Posted : April 13, 2021
Sponsor:
Collaborator:
Avanos Medical
Information provided by (Responsible Party):
Cherie Q. Marfori, George Washington University

Brief 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.

Condition or disease Intervention/treatment Phase
Hysterectomy Gynecologic Surgical Procedures Narcotic Use Pain, Postoperative Drug: Ropivacaine Infusion from ON-Q Pump Drug: Ropivacaine + Ketorolac Infusion from ON-Q Pump Drug: Normal Saline Infusion from ON-Q Pump Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double-blind study; the surgeon and the patient will not know which study group they are a part of. Only the IDS pharmacist and IDS pharmacy technician will know which group each study patient has been assigned to.
Primary Purpose: Treatment
Official Title: The Impact of the Continuous Infusion of Intraperitoneal Analgesics on Postoperative Pain After Minimally Invasive Hysterectomy: a Randomized Controlled Trial
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Experimental: Ropivacaine
Subjects will receive a continuous intraperitoneal infusion of ropivacaine
Drug: Ropivacaine Infusion from ON-Q Pump
Infusion of 0.2% ropivacaine at 8 mL/hour for 72 hours
Other Name: Naropin

Experimental: Ropivacaine + Ketorolac
Subjects will receive a continuous intraperitoneal infusion of ropivacaine + ketorolac
Drug: Ropivacaine + Ketorolac Infusion from ON-Q Pump
Infusion of 0.2% ropivacaine + 30 mg ketorolac at 8 mL/hour for 72 hours
Other Names:
  • Naropin
  • Toradol

Placebo Comparator: Normal Saline
Subjects will receive a continuous intraperitoneal infusion of normal saline
Drug: Normal Saline Infusion from ON-Q Pump
Infusion of 0.9% normal saline at 8 mL/hour for 72 hours
Other Name: Saline solution




Primary Outcome Measures :
  1. Pain Level 1 Hour Postoperative [ Time Frame: 1 hour postoperative ]
    Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"

  2. Pain Level 2 Hours Postoperative [ Time Frame: 2 hours postoperative ]
    Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"

  3. Pain Level 4 Hours Postoperative [ Time Frame: 4 hours postoperative ]
    Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"

  4. Pain Level 6 Hours Postoperative [ Time Frame: 6 hours postoperative ]
    Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"

  5. Pain Level 24 Hours Postoperative [ Time Frame: 24 hours postoperative ]
    Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"

  6. Pain Level 48 Hours Postoperative [ Time Frame: 48 hours postoperative ]
    Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"

  7. Pain Level 72 Hours Postoperative [ Time Frame: 72 hours postoperative ]
    Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"


Secondary Outcome Measures :
  1. The total dose of analgesics taken over the 72 postoperative hours [ Time Frame: Within 72 hours postoperative ]
    Each of the following was considered to be one dose: 1 g of paracetamol, 50 mg diclofenac, 400 mg ibuprofen, 50 mg tramadol



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130464


Locations
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United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: James Robinson, MD    202-877-0526    james.k.robinson@medstar.net   
Principal Investigator: James Robinson, MD         
The GW Medical Faculty Associates Recruiting
Washington, District of Columbia, United States, 20037
Contact: Cherie Marfori, MD    202-741-3000    cmarfori@mfa.gwu.edu   
Principal Investigator: Cherie Marfori, MD         
Sponsors and Collaborators
George Washington University
Avanos Medical
Investigators
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Principal Investigator: Gaby Moawad, MD Physician
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Responsible Party: Cherie Q. Marfori, Principal Investigator, George Washington University
ClinicalTrials.gov Identifier: NCT04130464    
Other Study ID Numbers: 180423
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Cherie Q. Marfori, George Washington University:
Intraperitoneal
Pain Pump
Ropivacaine
Ketorolac Tromethamine
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ketorolac
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action