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Malignant Neoplasms of Female Genital OrgansPhase 3NCT02740114

Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway

A Phase 3 study testing Bupivacaine, Liposomal Bupivacaine and Oxycodone in people with Malignant Neoplasms of Female Genital Organs and Gynecologic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Bupivacaine is a drug that is traditionally given as an injection to numb surgical sites. Liposomes are molecules that are similar to fats. Sometimes drugs are combined with liposomes to make them able to stay in the body for longer periods of time. This has been done with bupivacaine to create liposomal bupivacaine. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Bupivacaine, Liposomal Bupivacaine and Oxycodone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteUnited States
Study dates
31 Aug 2016to 23 Jul 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Undergoing an exploratory laparotomy for suspected gynecologic cancer, which includes metastatic disease from neoplasia originating in other organs
  • Planned participation in the Gynecologic Enhanced Recovery Pathway
  • Female 18 years of age or older
  • Patient must be able to read and speak English
  • Consents to being part of a randomized, single-blinded study
  • Patient has physical and mental capabilities to take part in study
  • Bilirubin less than or equal to 1.5 x upper limit of the normal range (ULN); Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) </=2.5 x ULN
  • If the patient is of childbearing potential, the patient must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study

Who cannot join

  • Sensitivity to amide-type local anesthetics
  • Patients on long-acting opioid medications, or scheduled (four or more times a day for seven or more days) short-acting opioid medications within the last 30 days
  • Emergency surgery of any type that does not allow for proper time for protocol review by the patient
  • Surgery that involves known/anticipated resection of anterior abdominal wall with plastic surgery reconstruction
  • Patients undergoing pelvic exenteration
  • Patients undergoing known/anticipated anterior abdominal wall hernia repairs
  • Patients weighing <50 kg

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway: A Single-Blinded, Randomized, Controlled Study

Bupivacaine is a drug that is traditionally given as an injection to numb surgical sites. Liposomes are molecules that are similar to fats. Sometimes drugs are combined with liposomes to make them able to stay in the body for longer periods of time. This has been done with bupivacaine to create liposomal bupivacaine.

The goal of this clinical research study is to compare the effects of bupivacaine to those of liposomal bupivacaine when given to patients who are having gynecologic surgery. Researchers want to compare how long the drugs work to numb the wound and how long patients take to recover from surgery.

Read the detailed description

Study Arms and Drug Administration:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study arms:

  • If you are in Arm 1, you will receive bupivacaine only.
  • If you are in Arm 2, you will receive a combination of liposomal bupivacaine and bupivacaine.

You will have an equal (50/50) chance of being assigned to either group. You will not know what you are receiving. However, the study staff will know what you are receiving.

In both cases, the drug(s) will be injected into your skin and tissue at the end of your surgery, right before the wound is closed.

Study Data Collection:

Every day while you are in the hospital recovering from surgery, you will be asked questions about pain, any side effects you may be having, symptoms, and opioid use.

Within 30 days after you leave the hospital, you may also be called and asked about side effects you may be having. If you are called, this call should last about 10-15 minutes. This information may also be collected during a routinely scheduled clinic visit and from the medical record.

Three (3) and 7 days after you leave the hospital, and then 1 time every week after that for a total of 8 weeks, you will be called or emailed and asked questions about any symptoms you may be having. If you are called, each call should last about 10-15 minutes.

If you are also enrolled on the study BS99-094 "Measuring the Symptom Distress of Cancer Patients: Development of a New Assessment System," information from your participation in this study may also be collected and used in that study.

Length of Study:

Your participation on this study will be over 8 weeks after you leave the hospital.

This is an investigational study. Both bupivacaine and liposomal bupivacaine are FDA approved and commercially available. It is investigational to compare the 2 drugs.

Up to 200 participants will be enrolled in this study. All will take part at MD Anderson.

Being tested
Bupivacaine, Liposomal Bupivacaine, Oxycodone, Pill Diary, Symptom Questionnaire
Keywords
Malignant neoplasms of female genital organs, Open gynecologic surgery, Local wound infiltration, Gynecologic cancer, Bupivacaine, Liposomal Bupivacaine, Oxycodone, ETH-Oxydose [DSC], OxyContin, OxyIR, Roxicodone, Questionnaires, Surveys, MD Anderson Symptom Inventory, MDASI, Pill diary, Medication log

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BupivacaineDrug

    150 mg (0.25%) injected on each side of the wound at the end of surgery before wound closure.

  • Liposomal BupivacaineDrug

    266 mg injected on each side of the wound at the end of surgery before wound closure.

  • OxycodoneDrug

    Also called ETH-Oxydose [DSC], OxyContin, OxyIR, Roxicodone

    1-2 tabs (5 mg) by mouth every 4 hours as needed for pain.

  • Pill DiaryBehavioural

    Also called Medication log

    Participants complete a pill diary every day for 30 days after hospital discharge.

  • Symptom QuestionnaireBehavioural

    Also called Survey, MD Anderson Symptom Inventory, MDASI

    Participants called or emailed and asked questions about symptoms three (3) and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.

Study groups in NCT02740114
Study groupRoleWhat they receive
Bupivacaine GroupActive comparatorLocal wound infiltration with Bupivacaine immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain. Participants complete a pill diary every day for 30 days after hospital discharge. Participants called or emailed and asked questions about symptoms three (3) and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
Receives: Drug: Bupivacaine; Drug: Oxycodone; Behavioral: Pill Diary; Behavioral: Symptom Questionnaire
Liposomal Bupivacaine + Bupivacaine GroupExperimentalLocal wound infiltration with Liposomal Bupivacaine and 0.25% Bupivacaine admixed immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain. Participants complete a pill diary every day for 30 days after hospital discharge. Participants called or emailed and asked questions about symptoms three (3) and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
Receives: Drug: Bupivacaine; Drug: Liposomal Bupivacaine; Drug: Oxycodone; Behavioral: Pill Diary; Behavioral: Symptom Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants Opioid-Free After Gynecologic Surgery for 48 Hours

    Treatment arms compared with respect to the proportion of patients opioid-free at 48 hours using the Cochran-Mantel-Haenszel test stratified by surgeon.

    Measured: 48 hours

Secondary outcomes (2)

  1. Participants Opioid-Free After Gynecologic Surgery

    Treatment arms compared with respect to the number of opioid-free days using the Cochran-Mantel-Haenszel test stratified by surgeon.

    Measured: 8 weeks

  2. Symptom Scores

    Daily pain scores were ascertained by routine nursing care every 4 hours while awake, on a 0 to 10 scale. Descriptive statistics and graphical methods used to summarize MD Anderson Symptom Inventory (MDASI) scores at each assessment time by treatment arm. For each symptom component, individuals were asked to rank symptom severity during the previous 24 hours on a scale of 0 to 10, with 0 being "not present "and 10 being "as bad as you can imagine". Symptom interference was also assessed on a 0 to 10 scale, with 0 being "did not interfere" and 10 being "interfered completely". Higher values represent worst outcomes.

    Measured: Days 0, 2 and 4 postoperatively, up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2016 (estimated)
  2. Study start31 Aug 2016
  3. Primary completion23 Jul 2020
  4. Study completion23 Jul 2020

Why it stopped: Per PIs request

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02740114
Sponsor's protocol ID
2015-1119
Other IDs
NCI-2016-00739
Status last verified
Sep 2021
First submitted
12 Apr 2016
Last updated
18 Oct 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Meyer LA, Corzo C, Iniesta MD, Munsell M, Shi Q, Pitcher B, Lasala J, Cain KE, Wang XS, Mena G, Ramirez PT. A prospective randomized trial comparing liposomal bupivacaine vs standard bupivacaine wound infiltration in open gynecologic surgery on an enhanced recovery pathway. Am J Obstet Gynecol. 2021 Jan;224(1):70.e1-70.e11. doi: 10.1016/j.ajog.2020.07.017. Epub 2020 Jul 16.

    PubMed 32682856

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bupivacaine, Liposomal Bupivacaine and Oxycodone in people with Malignant Neoplasms of Female Genital Organs and Gynecologic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants Opioid-Free After Gynecologic Surgery for 48 Hours (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02740114, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.

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