Malignant Female Reproductive System NeoplasmPhase 4NCT04258631
Liposomal Bupivacaine With or Without Hydromorphone for the Improvement of Pain Control After Laparotomy in Patients With Gynecological Malignancies
A Phase 4 study testing Hydromorphone, Laparotomy and Liposomal Bupivacaine in people with Malignant Female Reproductive System Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase IV trial studies how well liposomal bupivacaine with or without hydromorphone works in improving pain control during the first 24 hours after surgery in patients with gynecological malignancies undergoing laparotomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Malignant Female Reproductive System Neoplasm
- What is being tested?
- Hydromorphone, Laparotomy and Liposomal Bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2020to 8 Aug 2023
- Phase
- Phase 4
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery for suspected (based on consulting surgeon's opinion-imaging, laboratory [lab], pathology [path]) gynecological malignancy, enhanced recovery after surgery (ERAS) protocol
Who cannot join
- Inability to read or understand English
- Prehospitalization narcotic use if weekly average daily oral morphine equivalent of > 20 mg
- Chronic pain syndromes such as fibromyalgia
- Extensive surgery planned (surrogate for post-operative [postop] pain): Planned intensive care unit (ICU) admission, abdominoperineal resection, exenteration, use of intraoperative radiation (IORT), hyperthermic intraperitoneal chemotherapy (HIPEC)
- Contraindication to neuraxial analgesia:
- Coagulopathy
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- International normalized ratio (INR) > 1.2 current or predicted after surgery (e.g. planned right hepatic resection)
- Thrombocytopenia. Platelets (plts) < 100
- Hemophiliac disease states (hemophilia, von Willebrand disease, etc.)
- Patients receiving antithrombotic or thrombolytic therapy are excluded according to the American Society of Regional Anesthesia and Pain Medicine (ASRA) guidelines
- Localized infection at the potential site of injection
- Significant developmental or structural spinal abnormalities that would preclude a safe spinal technique. These include spina bifida, tethered spinal cord, lumbar spinal fusion, and active lumbar radiculopathy
- Patients with stage 4 or 5 kidney disease (glomerular filtration rate [GFR] less than 30 ml/min per 1.73 m^2)
- Intolerance or allergy to opioids, acetaminophen, or amide-type local anesthetics
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Wound Infiltration With Liposomal Bupivacaine With or Without Intrathecal Analgesia in Laparotomy for Gynecological Malignancy: A Randomized Controlled Trial
This phase IV trial studies how well liposomal bupivacaine with or without hydromorphone works in improving pain control during the first 24 hours after surgery in patients with gynecological malignancies undergoing laparotomy. Liposomal bupivacaine is routinely infiltrated into the skin surrounding the abdominal incision, and is effective in providing good relief of incisional pain. Hydromorphone is also a type of pain medication that may provide better management of deep abdominal pain. It is not yet known if giving liposomal bupivacaine with or without hydromorphone will work better in improving pain in patients with gynecological malignancies during the first 24 hours after surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate if no additional intervention is noninferior to intrathecal analgesia (ITA) for postoperative pain experience 24 hours after surgery after laparotomy for gynecological malignancy within an established enhanced recovery pathway which includes incisional liposomal bupivacaine (ILB).
II. Evaluate the effect of intrathecal analgesia on patient satisfaction with postoperative analgesia after laparotomy for gynecological malignancy.
III. Report the impact of ITA use on cost. IV. Validate the Quality of Recovery (QOR)-15 in our population.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care laparotomy and then receive liposomal bupivacaine.
ARM II: Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone intrathecally (IT).
- Being tested
- Hydromorphone, Laparotomy, Liposomal Bupivacaine, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
Also called (-)-Hydromorphone, Dihydromorphinone, Hydromorphon
Given IT
LaparotomyProcedure or surgery
Undergo laparotomy
Liposomal BupivacaineDrug
Also called Bupivacaine Liposome Injectable Suspension, Exparel
Drug
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (laparotomy, liposomal bupivacaine) | Active comparator | Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Receives: Procedure: Laparotomy; Drug: Liposomal Bupivacaine; Other: Questionnaire Administration |
| Arm II (laparotomy, liposomal bupivacaine, hydromorphone) | Experimental | Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Receives: Drug: Hydromorphone; Procedure: Laparotomy; Drug: Liposomal Bupivacaine; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Benefit of Analgesia Score (OBAS)
The Overall Benefit of Analgesia Score (OBAS) is a multi-dimensional survey that measures a patient's benefit from postoperative pain therapy. It assesses pain intensity, opioid-related adverse events, and patient satisfaction with analgesia. Each of 7 questions are scored on a scale from 0 to 4 where 0=minimal/not at all and 4=maximum/very much. The total score is a sum of the 7 item scores with question 7 scored as 4 minus the patient reported number. Total scores range from 0 to 28 with lower scores representing greater benefit from analgesic therapy. The median total OBAS score for each group is presented.
Measured: Up to 24 hours after surgery
Secondary outcomes (13)
Cumulative 24-hour Narcotic Consumption
Various narcotic medications are standardized and reported as Morphine Milligram Equivalents (MME).
Measured: Up to 24 hours after surgery
Post-operative Pain Scores
Postoperative pain is scored on a scale of 0 - 10, with the lower score showing a better outcome.
Measured: Up to 24 hours after surgery
Time to First Analgesic Request
Amount of time from leaving surgery to the first request for pain relief.
Measured: Up to 24 hours after surgery
Use of Intravenous (IV) Patient-controlled Analgesia
Number of patients that used IV, patient controlled analgesia after surgery.
Measured: Up to 24 hours after surgery
Use of Intravenous Rescue Opioids
Number of patients that needed IV rescue opioids after surgery.
Measured: Up to 24 hours after surgery
Length of Stay
Length of associated hospitalization in days.
Measured: Up to 1 week after surgery
Additional Fluid Requirement After 24 Hours of Surgery
Number of patients requiring additional IV fluids after surgery.
Measured: Up to 24 hours after surgery
Weight Gain Following Surgery
Weight difference post- and pre-surgery.
Measured: Up to 24 hours after surgery
Total Cost of Care
All medical costs occurring during hospitalization.
Measured: Entire hospitalization, approximately 2-5 days
Incidence of Adverse Events
Reported as the number participants reporting one or more adverse events on each study arm.
Measured: Up to 24 hours after surgery
Operating Room Time
Length of time from when the patient entered the operating room to when they left.
Measured: Approximately 8 hours
Surgical Time
Time from first incision to surgical site closure.
Measured: Approximately 8 hours
Pain Management
Pharmaceutical costs associated with pain management.
Measured: Whole hospitalization, approximately 2-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start9 Jul 2020
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant Female Reproductive System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean C Dowdy, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258631
- Sponsor's protocol ID
- MC2061
- Other IDs
- NCI-2020-00609, 19-010500, MC2061
- Status last verified
- Oct 2024
- First submitted
- 4 Feb 2020
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Infiltration With Liposomal Bupivacaine With or Without Intrathecal Analgesia in Laparotomy for Gynecological Malignancy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04258631
- Acronym / sponsor ID
- MC2061
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Posted 16 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase IV trial studies how well liposomal bupivacaine with or without hydromorphone works in improving pain control during the first 24 hours after surgery in patients with gynecological malignancies undergoing laparotomy. Liposomal bupivacaine is routinely infiltrated into the skin surrounding the abdominal incision, and is effective in providing good relief of incisional pain. Hydromorphone is also a type of pain medication that may provide better management of deep abdominal pain. It is not yet known if giving liposomal bupivacaine with or without hydromorphone will work better in improving pain in patients with gynecological malignancies during the first 24 hours after surgery.
Detailed description
PRIMARY OBJECTIVES:
- Evaluate if no additional intervention is noninferior to intrathecal analgesia (ITA) for postoperative pain experience 24 hours after surgery after laparotomy for gynecological malignancy within an established enhanced recovery pathway which includes incisional liposomal bupivacaine (ILB).
II. Evaluate the effect of intrathecal analgesia on patient satisfaction with postoperative analgesia after laparotomy for gynecological malignancy.
III. Report the impact of ITA use on cost. IV. Validate the Quality of Recovery (QOR)-15 in our population.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care laparotomy and then receive liposomal bupivacaine.
ARM II: Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone intrathecally (IT).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (laparotomy, liposomal bupivacaine) | Active comparator | Procedure: Laparotomy, Drug: Liposomal Bupivacaine, Other: Questionnaire AdministrationPatients undergo standard of care laparotomy and then receive liposomal bupivacaine. |
| Arm II (laparotomy, liposomal bupivacaine, hydromorphone) | Experimental | Drug: Hydromorphone, Procedure: Laparotomy, Drug: Liposomal Bupivacaine, Other: Questionnaire AdministrationPatients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective surgery for suspected (based on consulting surgeon's opinion-imaging, laboratory [lab], pathology [path]) gynecological malignancy, enhanced recovery after surgery (ERAS) protocol
Key exclusion criteria (15 listed)
- Inability to read or understand English
- Prehospitalization narcotic use if weekly average daily oral morphine equivalent of > 20 mg
- Chronic pain syndromes such as fibromyalgia
- Extensive surgery planned (surrogate for post-operative [postop] pain): Planned intensive care unit (ICU) admission, abdominoperineal resection, exenteration, use of intraoperative radiation (IORT), hyperthermic intraperitoneal chemotherapy (HIPEC)
- Contraindication to neuraxial analgesia:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydromorphoneAlso: (-)-Hydromorphone, Dihydromorphinone, HydromorphonGiven IT | Drug | Arm II (laparotomy, liposomal bupivacaine, hydromorphone) |
| LaparotomyUndergo laparotomy | Procedure or surgery | Arm I (laparotomy, liposomal bupivacaine), Arm II (laparotomy, liposomal bupivacaine, hydromorphone) |
| Liposomal BupivacaineAlso: Bupivacaine Liposome Injectable Suspension, ExparelDrug | Drug | Arm I (laparotomy, liposomal bupivacaine), Arm II (laparotomy, liposomal bupivacaine, hydromorphone) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (laparotomy, liposomal bupivacaine), Arm II (laparotomy, liposomal bupivacaine, hydromorphone) |
Primary outcome
Overall Benefit of Analgesia Score (OBAS)
Time frame: Up to 24 hours after surgery
The Overall Benefit of Analgesia Score (OBAS) is a multi-dimensional survey that measures a patient's benefit from postoperative pain therapy. It assesses pain intensity, opioid-related adverse events, and patient satisfaction with analgesia. Each of 7 questions are scored on a scale from 0 to 4 where 0=minimal/not at all and 4=maximum/very much. The total score is a sum of the 7 item scores with question 7 scored as 4 minus the patient reported number. Total scores range from 0 to 28 with lower scores representing greater benefit from analgesic therapy. The median total OBAS score for each group is presented.
13 secondary outcomes
Cumulative 24-hour Narcotic Consumption
Time frame: Up to 24 hours after surgery
Post-operative Pain Scores
Time frame: Up to 24 hours after surgery
Time to First Analgesic Request
Time frame: Up to 24 hours after surgery
Use of Intravenous (IV) Patient-controlled Analgesia
Time frame: Up to 24 hours after surgery
Use of Intravenous Rescue Opioids
Time frame: Up to 24 hours after surgery
Length of Stay
Time frame: Up to 1 week after surgery
Additional Fluid Requirement After 24 Hours of Surgery
Time frame: Up to 24 hours after surgery
Weight Gain Following Surgery
Time frame: Up to 24 hours after surgery
Total Cost of Care
Time frame: Entire hospitalization, approximately 2-5 days
Incidence of Adverse Events
Time frame: Up to 24 hours after surgery
Operating Room Time
Time frame: Approximately 8 hours
Surgical Time
Time frame: Approximately 8 hours
Pain Management
Time frame: Whole hospitalization, approximately 2-5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean C Dowdy principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydromorphone, Laparotomy and Liposomal Bupivacaine in people with Malignant Female Reproductive System Neoplasm, run by Mayo Clinic 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 1 inclusion and 15 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: finished, as of the sponsor's last update on 16 Oct 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 16 Oct 2024). 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?
Overall Benefit of Analgesia Score (OBAS) (time frame: Up to 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2024.