Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04849858
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine

Brief Summary:
The purpose of this research study is to find out which type of transversus abdomens plane (TAP) and block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fibroids Uterine Cancer Drug: Bupivacaine Drug: Liposomal bupivacaine Phase 3

Detailed Description:

The purpose of this research study is to find out which type of TAP block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.

An anesthesiologist participating on this study will describe the TAP block to you during your preoperative interview and will obtain your consent for the block procedure with your anesthesia consent prior to the procedure. TAP blocks are one of the various methods of controlling your pain after surgery. They are typically placed with an anesthetic agent, such as bupivacaine. The U.S. Food and Drug Administration (FDA) has recently approved a longer-acting form of the anesthetic used in this study, liposomal bupivacaine. Although both medications, bupivacaine and liposomal bupivacaine are approved by the FDA, there are only a few trials such as this one, in the United States, comparing the various types of TAP blocks. No studies exist comparing the re-dosing of a TAP block, as we will be doing in this study.

Currently, the standard of care after a gynecologic procedure may or may not include receiving a TAP block. This was a decision typically made, with your consent, at the discretion of an anesthesiologist and your surgeon. As per the standard of care, after surgery, you would be given oral pain medications to control your pain and intravenous pain medications for severe breakthrough pain. Our study will not change your post-operative pain medication schedule or timing. It will only study the effectiveness of the TAP block you get in controlling your pain.

Even though the medicines (bupivacaine or liposomal bupivacaine) used in this study are FDA-approved, the use of these drugs in this study is investigational.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This is a prospective cohort study with retrospective data analysis. Patients will be assigned to treatment groups on a consecutive basis. We will be recruiting 45 eligible patients from our University of California Irvine (UCI) gynecologic oncology clinic. Each clinic patient who is scheduled for surgery will be screened for eligibility. The first 15 patients enrolled will receive perioperative plain bupivacaine transversus abdominis plane (TAP) blocks. The next 15 patients enrolled will receive perioperative single-dose Liposomal Bupivacaine (LB) TAP blocks. The final 15 patients enrolled will receive perioperative LB TAP blocks followed by redosing of the TAP blocks in 48-60 hours.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures: A Quality Improvement Project in Post-operative Pain
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Active Comparator: Bupivacaine TAP Block
The first 15 patients enrolled will receive perioperative plain bupivacaine TAP blocks.
Drug: Bupivacaine
Participants in this group will receive a TAP block using the drug Bupivacaine.

Active Comparator: Liposomal Bupivacaine TAP Block
After enrolling all 15 participants in the first arm, the next 15 patients enrolled will receive perioperative single-dose Liposomal Bupivacaine TAP blocks.
Drug: Liposomal bupivacaine
Participants in this group will receive a TAP block using the drug Liposomal Bupivacaine.

Active Comparator: Liposomal Bupivacaine TAP Block with Re-dosing
After enrolling all 30 patients in the first two arms, the final 15 patients enrolled will receive perioperative Liposomal Bupivacaine TAP blocks followed by redosing of the TAP blocks in 48-60 hours.
Drug: Liposomal bupivacaine
Participants in this group will receive a TAP block using the drug Liposomal Bupivacaine followed by a re-dosing during their hospitalization
Other Name: With Re-dosing




Primary Outcome Measures :
  1. Post-operative opioid consumption [ Time Frame: Post-operative day 0 to day 8 ]
    Morphine equivalents (milligrams)


Secondary Outcome Measures :
  1. Pain at rest and during activity [ Time Frame: Post-operative day 0 to day 8 ]
    Measured pain on a Visual Analog Scale (VAS), Scale 0 (no pain) - 10 (high pain)

  2. Nausea/Vomiting [ Time Frame: Post-operative day 0 to day 8 ]
    Presence or Absence of nausea or vomiting

  3. Ileus [ Time Frame: Post-operative day 0 to day 8 ]
    Presence or Absence of Ileus

  4. Bowel Function [ Time Frame: Post-operative day 0 to day 8 ]
    Time to return of bowel function (days)

  5. Ambulation [ Time Frame: Post-operative day 0 to day 8 ]
    Time to first ambulation (days)

  6. Hospital stay [ Time Frame: Post-operative day 0 to day 8 ]
    Length of hospital stay (days)

  7. Surgical Adverse Events [ Time Frame: Post-operative day 0 to day 8 ]
    Presence or Absence of adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study applies to patients receiving care with a gynecologic oncologist
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Age ≥ 18 years old
  • Must be undergoing an open gynecologic procedure through a midline vertical incision with a gynecologic oncologist

Exclusion Criteria

  • History of chronic pain
  • History of opioid dependence
  • Suspected or confirmed history of endometriosis
  • History of fibromyalgia
  • Suspected or confirmed interstitial cystitis or painful bladder syndrome
  • History of or current opioid use prior to surgery
  • Hypersensitivity to bupivacaine
  • Severe hepatic or renal disease

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): NCT04849858


Contacts
Layout table for location contacts
Contact: Jill H Tseng, MD 714-456-8000 jillt2@hs.uci.edu

Locations
Layout table for location information
United States, California
University of California, Irvine Recruiting
Orange, California, United States, 92868
Contact: Jill H Tseng, MD    714-456-8000    jillt2@hs.uci.edu   
Sponsors and Collaborators
University of California, Irvine
Investigators
Layout table for investigator information
Principal Investigator: Jill H Tseng, MD University of California, Irvine
Layout table for additonal information
Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT04849858    
Other Study ID Numbers: UCI 19-16 HS# 2019-4981
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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 University of California, Irvine:
ovarian cancer
fibroids
uterine cancer
Transverse abdominis plane block
TAP block
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Leiomyoma
Uterine Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Uterine Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents