Trial Outcomes & Findings for Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway (NCT NCT02740114)
NCT ID: NCT02740114
Last Updated: 2021-10-18
Results Overview
Treatment arms compared with respect to the proportion of patients opioid-free at 48 hours using the Cochran-Mantel-Haenszel test stratified by surgeon.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
105 participants
Primary outcome timeframe
48 hours
Results posted on
2021-10-18
Participant Flow
All patients were consented during preoperative visit at MD Anderson Cancer Center from August 31st 2016 to August 31st 2017.
One patient was excluded after randomization because of scheduled opioid use, and 2 patients were excluded because the surgical approach changed to minimally invasive surgery (these 3 patients were never treated). All patients treated completed the trial.
Participant milestones
| Measure |
Active Comparator: Bupivacaine Group
Local wound infiltration with Bupivacaine immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5mg) 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 3 and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
|
Experimental: Liposomal Bupivacaine + Bupivacaine Group
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 3 and 7 days after hospital discharge, and th3en 1 time every week after that for a total of 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
48
|
|
Overall Study
COMPLETED
|
54
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway
Baseline characteristics by cohort
| Measure |
Active Comparator: Bupivacaine Group
n=54 Participants
Local wound infiltration with Bupivacaine immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5mg) 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 3 and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
|
Experimental: Liposomal Bupivacaine + Bupivacaine Group
n=48 Participants
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 3 and 7 days after hospital discharge, and th3en 1 time every week after that for a total of 8 weeks.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Continuous
|
62.5 years
n=5 Participants
|
59 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursTreatment arms compared with respect to the proportion of patients opioid-free at 48 hours using the Cochran-Mantel-Haenszel test stratified by surgeon.
Outcome measures
| Measure |
Active Comparator: Bupivacaine Group
n=54 Participants
Local wound infiltration with Bupivacaine immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5mg) 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 3 and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
|
Experimental: Liposomal Bupivacaine + Bupivacaine Group
n=48 Participants
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 3 and 7 days after hospital discharge, and th3en 1 time every week after that for a total of 8 weeks.
|
|---|---|---|
|
Participants Opioid-Free After Gynecologic Surgery for 48 Hours
|
14.8 percentage of participants
Interval 6.7 to 27.1
|
16.70 percentage of participants
Interval 7.4 to 30.2
|
SECONDARY outcome
Timeframe: 8 weeksTreatment arms compared with respect to the number of opioid-free days using the Cochran-Mantel-Haenszel test stratified by surgeon.
Outcome measures
| Measure |
Active Comparator: Bupivacaine Group
n=54 Participants
Local wound infiltration with Bupivacaine immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5mg) 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 3 and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
|
Experimental: Liposomal Bupivacaine + Bupivacaine Group
n=48 Participants
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 3 and 7 days after hospital discharge, and th3en 1 time every week after that for a total of 8 weeks.
|
|---|---|---|
|
Participants Opioid-Free After Gynecologic Surgery
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Days 0, 2 and 4 postoperatively, up to 8 weeksDaily 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.
Outcome measures
| Measure |
Active Comparator: Bupivacaine Group
n=54 Participants
Local wound infiltration with Bupivacaine immediately prior to wound closure during gynecological surgery. Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5mg) 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 3 and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
|
Experimental: Liposomal Bupivacaine + Bupivacaine Group
n=48 Participants
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 3 and 7 days after hospital discharge, and th3en 1 time every week after that for a total of 8 weeks.
|
|---|---|---|
|
Symptom Scores
Median daily pain scores Postoperative day 2
|
2.2 score on a scale
Interval 0.6 to 3.5
|
2.5 score on a scale
Interval 1.0 to 3.0
|
|
Symptom Scores
Median daily pain scores Postoperative day 4
|
0.8 score on a scale
Interval 0.2 to 3.0
|
1.2 score on a scale
Interval 0.6 to 3.4
|
|
Symptom Scores
Median daily pain scores Postoperative day 0
|
2.5 score on a scale
Interval 1.5 to 4.0
|
2.7 score on a scale
Interval 1.6 to 4.2
|
Adverse Events
Active Comparator: Bupivacaine Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental: Liposomal Bupivacaine + Bupivacaine Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Pedro Ramirez, MD /Professor, Gyn Onc & Reproductive Med
UT MD Anderson Cancer Center
Phone: 713-745-5498
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place