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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-00609 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19-010500 | Other Identifier | Mayo Clinic Institutional Review Board | |
| MC2061 | Other Identifier | Mayo Clinic in Rochester |
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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.
PRIMARY OBJECTIVES:
I. 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (laparotomy, liposomal bupivacaine) | Active Comparator | Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. |
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| Arm II (laparotomy, liposomal bupivacaine, hydromorphone) | Experimental | Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone | Drug | Given IT |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative 24-hour Narcotic Consumption | Various narcotic medications are standardized and reported as Morphine Milligram Equivalents (MME). | Up to 24 hours after surgery |
| Post-operative Pain Scores |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery-15 (QoR-15) Total Score | The Quality of Recovery (QoR-15) questionnaire is a 15-item survey that patients rate to measure the quality of their recovery after surgery. Each item in the questionnaire is graded on an 11-point numeric rating scale with total scores ranging from 15 to 150. Higher scores indicate better recovery. | At 24 hours after surgery |
Inclusion Criteria:
Exclusion Criteria:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Sean C Dowdy | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Laparotomy, Liposomal Bupivacaine) | Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies |
| FG001 | Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2021 |
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| Laparotomy | Procedure | Undergo laparotomy |
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| Liposomal Bupivacaine | Drug | Drug |
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| Questionnaire Administration | Other | Ancillary studies |
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Postoperative pain is scored on a scale of 0 - 10, with the lower score showing a better outcome.
| Up to 24 hours after surgery |
| Time to First Analgesic Request | Amount of time from leaving surgery to the first request for pain relief. | Up to 24 hours after surgery |
| Use of Intravenous (IV) Patient-controlled Analgesia | Number of patients that used IV, patient controlled analgesia after surgery. | Up to 24 hours after surgery |
| Use of Intravenous Rescue Opioids | Number of patients that needed IV rescue opioids after surgery. | Up to 24 hours after surgery |
| Length of Stay | Length of associated hospitalization in days. | Up to 1 week after surgery |
| Additional Fluid Requirement After 24 Hours of Surgery | Number of patients requiring additional IV fluids after surgery. | Up to 24 hours after surgery |
| Weight Gain Following Surgery | Weight difference post- and pre-surgery. | Up to 24 hours after surgery |
| Total Cost of Care | All medical costs occurring during hospitalization. | 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. | Up to 24 hours after surgery |
| Operating Room Time | Length of time from when the patient entered the operating room to when they left. | Approximately 8 hours |
| Surgical Time | Time from first incision to surgical site closure. | Approximately 8 hours |
| Pain Management | Pharmaceutical costs associated with pain management. | Whole hospitalization, approximately 2-5 days |
Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Laparotomy, Liposomal Bupivacaine) | Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies |
| BG001 | Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) | Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age recorded at the time of surgery. | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 24 hours after surgery |
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| Secondary | Cumulative 24-hour Narcotic Consumption | Various narcotic medications are standardized and reported as Morphine Milligram Equivalents (MME). | Posted | Mean | Standard Deviation | Morphine Milligram Equivalents (MME) | Up to 24 hours after surgery |
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| Secondary | Post-operative Pain Scores | Postoperative pain is scored on a scale of 0 - 10, with the lower score showing a better outcome. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 24 hours after surgery |
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| Secondary | Time to First Analgesic Request | Amount of time from leaving surgery to the first request for pain relief. | Analyses were based on treatment received, not randomization arm. | Posted | Median | Inter-Quartile Range | minutes | Up to 24 hours after surgery |
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| Secondary | Use of Intravenous (IV) Patient-controlled Analgesia | Number of patients that used IV, patient controlled analgesia after surgery. | Posted | Count of Participants | Participants | Up to 24 hours after surgery |
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| Secondary | Use of Intravenous Rescue Opioids | Number of patients that needed IV rescue opioids after surgery. | Posted | Count of Participants | Participants | Up to 24 hours after surgery |
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| Secondary | Length of Stay | Length of associated hospitalization in days. | Posted | Median | Inter-Quartile Range | days | Up to 1 week after surgery |
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| Secondary | Additional Fluid Requirement After 24 Hours of Surgery | Number of patients requiring additional IV fluids after surgery. | Posted | Count of Participants | Participants | Up to 24 hours after surgery |
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| Secondary | Weight Gain Following Surgery | Weight difference post- and pre-surgery. | Data not collected | Posted | Up to 24 hours after surgery |
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| Secondary | Total Cost of Care | All medical costs occurring during hospitalization. | Posted | Median | Inter-Quartile Range | dollars | Entire hospitalization, approximately 2-5 days |
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| Secondary | Incidence of Adverse Events | Reported as the number participants reporting one or more adverse events on each study arm. | Posted | Count of Participants | Participants | Up to 24 hours after surgery |
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| Secondary | Operating Room Time | Length of time from when the patient entered the operating room to when they left. | Posted | Median | Inter-Quartile Range | hours | Approximately 8 hours |
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| Secondary | Surgical Time | Time from first incision to surgical site closure. | Posted | Median | Inter-Quartile Range | hours | Approximately 8 hours |
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| Secondary | Pain Management | Pharmaceutical costs associated with pain management. | Posted | Median | Inter-Quartile Range | dollars | Whole hospitalization, approximately 2-5 days |
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| Other Pre-specified | Quality of Recovery-15 (QoR-15) Total Score | The Quality of Recovery (QoR-15) questionnaire is a 15-item survey that patients rate to measure the quality of their recovery after surgery. Each item in the questionnaire is graded on an 11-point numeric rating scale with total scores ranging from 15 to 150. Higher scores indicate better recovery. | Posted | Median | Inter-Quartile Range | score on a scale | At 24 hours after surgery |
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Up to 24 hours after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Laparotomy, Liposomal Bupivacaine) | Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies | 0 | 59 | 0 | 59 | 0 | 59 |
| EG001 | Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) | Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies | 0 | 46 | 1 | 46 | 0 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spinal headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean C. Dowdy, M.D. | Mayo Clinic | 507-266-0225 | Dowdy.Sean@mayo.edu |
| Aug 2, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 2, 2022 | Aug 2, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| D007813 | Laparotomy |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D013514 | Surgical Procedures, Operative |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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