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

Primary Purpose

Malignant Neoplasms of Female Genital Organs, Gynecologic Cancer

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Liposomal Bupivacaine
Oxycodone
Pill Diary
Symptom Questionnaire
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Neoplasms of Female Genital Organs focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Undergoing an exploratory laparotomy for suspected gynecologic cancer, which includes metastatic disease from neoplasia originating in other organs
  2. Planned participation in the Gynecologic Enhanced Recovery Pathway
  3. Female 18 years of age or older
  4. Patient must be able to read and speak English
  5. Consents to being part of a randomized, single-blinded study
  6. Patient has physical and mental capabilities to take part in study
  7. 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
  8. 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

Exclusion Criteria:

  1. Sensitivity to amide-type local anesthetics
  2. 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
  3. Emergency surgery of any type that does not allow for proper time for protocol review by the patient
  4. Surgery that involves known/anticipated resection of anterior abdominal wall with plastic surgery reconstruction
  5. Patients undergoing pelvic exenteration
  6. Patients undergoing known/anticipated anterior abdominal wall hernia repairs
  7. Patients weighing <50 kg

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bupivacaine Group

Liposomal Bupivacaine + Bupivacaine Group

Arm Description

Local 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.

Local 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 12, 2016
Last Updated
September 21, 2021
Sponsor
M.D. Anderson Cancer Center
Collaborators
Pacira Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02740114
Brief Title
Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Per PIs request
Study Start Date
August 31, 2016 (Actual)
Primary Completion Date
July 23, 2020 (Actual)
Study Completion Date
July 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Pacira Pharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasms of Female Genital Organs, Gynecologic Cancer
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine Group
Arm Type
Active Comparator
Arm Description
Local 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.
Arm Title
Liposomal Bupivacaine + Bupivacaine Group
Arm Type
Experimental
Arm Description
Local 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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
150 mg (0.25%) injected on each side of the wound at the end of surgery before wound closure.
Intervention Type
Drug
Intervention Name(s)
Liposomal Bupivacaine
Intervention Description
266 mg injected on each side of the wound at the end of surgery before wound closure.
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Other Intervention Name(s)
ETH-Oxydose [DSC], OxyContin, OxyIR, Roxicodone
Intervention Description
1-2 tabs (5 mg) by mouth every 4 hours as needed for pain.
Intervention Type
Behavioral
Intervention Name(s)
Pill Diary
Other Intervention Name(s)
Medication log
Intervention Description
Participants complete a pill diary every day for 30 days after hospital discharge.
Intervention Type
Behavioral
Intervention Name(s)
Symptom Questionnaire
Other Intervention Name(s)
Survey, MD Anderson Symptom Inventory, MDASI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participants Opioid-Free After Gynecologic Surgery for 48 Hours
Description
Treatment arms compared with respect to the proportion of patients opioid-free at 48 hours using the Cochran-Mantel-Haenszel test stratified by surgeon.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Participants Opioid-Free After Gynecologic Surgery
Description
Treatment arms compared with respect to the number of opioid-free days using the Cochran-Mantel-Haenszel test stratified by surgeon.
Time Frame
8 weeks
Title
Symptom Scores
Description
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.
Time Frame
Days 0, 2 and 4 postoperatively, up to 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Ramirez, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32682856
Citation
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.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

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

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