Trial Outcomes & Findings for Liposomal Bupivacaine in Vaginal Hysterectomy (NCT NCT03907033)
NCT ID: NCT03907033
Last Updated: 2021-10-15
Results Overview
Participants post-surgical analgesic medication use of IV hydrocodone and oxycodone measured in morphine equivalents (ME)
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
28 participants
Primary outcome timeframe
First 72 hours following surgery completion
Results posted on
2021-10-15
Participant Flow
Participant milestones
| Measure |
Standard Bupivacaine
Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
Liposomal Bupivacaine
Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments
Liposomal bupivacaine: Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
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|---|---|---|
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Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Bupivacaine
n=14 Participants
Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
Liposomal Bupivacaine
n=14 Participants
Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments
Liposomal bupivacaine: Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
Total
n=28 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
55.2 years
STANDARD_DEVIATION 10.96 • n=14 Participants
|
60.4 years
STANDARD_DEVIATION 12.56 • n=14 Participants
|
57.8 years
STANDARD_DEVIATION 11.86 • n=28 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=14 Participants
|
14 Participants
n=14 Participants
|
28 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=28 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
14 participants
n=14 Participants
|
28 participants
n=28 Participants
|
PRIMARY outcome
Timeframe: First 72 hours following surgery completionParticipants post-surgical analgesic medication use of IV hydrocodone and oxycodone measured in morphine equivalents (ME)
Outcome measures
| Measure |
Standard Bupivacaine
n=14 Participants
Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
Liposomal Bupivacaine
n=14 Participants
Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments
Liposomal bupivacaine: Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
|---|---|---|
|
Total Post-surgical Opioid Medication Use
Hydrocodone
|
0 Morphine Equivalents (ME)
Interval 0.0 to 0.0
|
0 Morphine Equivalents (ME)
Interval 0.0 to 0.0
|
|
Total Post-surgical Opioid Medication Use
Oxycodone
|
30.0 Morphine Equivalents (ME)
Interval 0.0 to 82.5
|
30.0 Morphine Equivalents (ME)
Interval 0.0 to 135.0
|
PRIMARY outcome
Timeframe: First 72 hours following surgery completionParticipants post-surgical analgesic medication use of Ibuprofen and acetaminophen measured in milligrams (mg)
Outcome measures
| Measure |
Standard Bupivacaine
n=14 Participants
Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
Liposomal Bupivacaine
n=14 Participants
Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments
Liposomal bupivacaine: Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
|---|---|---|
|
Total Post-surgical Analgesic Medication Use
Tylenol
|
6500.0 mg
Interval 0.0 to 13000.0
|
6500.0 mg
Interval 500.0 to 13000.0
|
|
Total Post-surgical Analgesic Medication Use
Ibuprofen
|
5400.0 mg
Interval 3000.0 to 13200.0
|
4800.0 mg
Interval 0.0 to 13200.0
|
SECONDARY outcome
Timeframe: Assessed while patient in PACU for recovery post-surgery per standard procedurePopulation: Data not collected or analyzed
Scale Ranges from 0 (no pain) to 10 (extreme pain)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24, 48, and 72 hours post-surgery completionScale Ranges from 0 (no pain) to 10 (extreme pain)
Outcome measures
| Measure |
Standard Bupivacaine
n=14 Participants
Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
Liposomal Bupivacaine
n=14 Participants
Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments
Liposomal bupivacaine: Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
|---|---|---|
|
VAS Pain Score at 24, 48, and 72 Hours Post-surgery Completion
24 hours post-surgery
|
3.1 score on a scale
Interval 1.0 to 7.5
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3.5 score on a scale
Interval 0.0 to 7.5
|
|
VAS Pain Score at 24, 48, and 72 Hours Post-surgery Completion
48 hours post-surgery
|
2.5 score on a scale
Interval 1.0 to 5.8
|
3.6 score on a scale
Interval 0.0 to 9.0
|
|
VAS Pain Score at 24, 48, and 72 Hours Post-surgery Completion
72 hours post-surgery
|
1.6 score on a scale
Interval 0.3 to 4.5
|
2.4 score on a scale
Interval 0.0 to 7.5
|
SECONDARY outcome
Timeframe: 24, 48, and 72 hours post-surgeryNumber of times patient reported feeling nauseous
Outcome measures
| Measure |
Standard Bupivacaine
n=14 Participants
Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
Liposomal Bupivacaine
n=14 Participants
Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments
Liposomal bupivacaine: Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
|---|---|---|
|
Nausea at 24, 48, and 72 Hours Post-surgery Completion
24 hours post-surgery
|
0.0 events
Interval 0.0 to 3.0
|
0.0 events
Interval 0.0 to 22.0
|
|
Nausea at 24, 48, and 72 Hours Post-surgery Completion
48 hours post-surgery
|
0.0 events
Interval 0.0 to 6.0
|
0.0 events
Interval 0.0 to 20.0
|
|
Nausea at 24, 48, and 72 Hours Post-surgery Completion
72 hours post-surgery
|
0.0 events
Interval 0.0 to 3.0
|
0.0 events
Interval 0.0 to 14.0
|
SECONDARY outcome
Timeframe: 24, 48, and 72 hours post-surgeryNumber of times the patient vomited
Outcome measures
| Measure |
Standard Bupivacaine
n=14 Participants
Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
Liposomal Bupivacaine
n=14 Participants
Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments
Liposomal bupivacaine: Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
|---|---|---|
|
Emesis at 24, 48, and 72 Hours Post-surgery Completion
24 hours post-surgery
|
0.0 events
Interval 0.0 to 1.0
|
0.0 events
Interval 0.0 to 2.0
|
|
Emesis at 24, 48, and 72 Hours Post-surgery Completion
48 hours post-surgery
|
0.0 events
Interval 0.0 to 0.0
|
0.0 events
Interval 0.0 to 1.0
|
|
Emesis at 24, 48, and 72 Hours Post-surgery Completion
72 hours post-surgery
|
0.0 events
Interval 0.0 to 0.0
|
0.0 events
Interval 0.0 to 11.0
|
SECONDARY outcome
Timeframe: At voiding trial prior to discharge from hospital, approximately 72 hoursNumber of patients who had post-void residual (PVR) \>150cc's at voiding trial prior to discharge
Outcome measures
| Measure |
Standard Bupivacaine
n=14 Participants
Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
Liposomal Bupivacaine
n=14 Participants
Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments
Liposomal bupivacaine: Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
|---|---|---|
|
Urinary Retention
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 72 hours and 7-10 days post surgeryAssessed on 0-10 scale (0 being worst level of satisfaction, 10 being best level)
Outcome measures
| Measure |
Standard Bupivacaine
n=14 Participants
Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
Liposomal Bupivacaine
n=14 Participants
Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments
Liposomal bupivacaine: Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
|---|---|---|
|
Patient Satisfaction With Pain Management at 72 Hours and 7-10 Days Post Surgery
72 hours post-surgery
|
10.0 score on a scale
Interval 5.0 to 10.0
|
9.5 score on a scale
Interval 1.0 to 10.0
|
|
Patient Satisfaction With Pain Management at 72 Hours and 7-10 Days Post Surgery
7-10 days post-surgery
|
10.00 score on a scale
Interval 7.0 to 10.0
|
9.0 score on a scale
Interval 8.0 to 10.0
|
Adverse Events
Standard Bupivacaine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Liposomal Bupivacaine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Bupivacaine
n=14 participants at risk
Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
Liposomal Bupivacaine
n=14 participants at risk
Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments
Liposomal bupivacaine: Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.
Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
|
|---|---|---|
|
Renal and urinary disorders
Urinary Retention
|
7.1%
1/14 • Adverse events were collected post operative on all participants, approximately 7 days.
|
7.1%
1/14 • Adverse events were collected post operative on all participants, approximately 7 days.
|
|
Renal and urinary disorders
Urinary Incontinence
|
7.1%
1/14 • Adverse events were collected post operative on all participants, approximately 7 days.
|
7.1%
1/14 • Adverse events were collected post operative on all participants, approximately 7 days.
|
|
Surgical and medical procedures
Protruding sutures
|
7.1%
1/14 • Adverse events were collected post operative on all participants, approximately 7 days.
|
0.00%
0/14 • Adverse events were collected post operative on all participants, approximately 7 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place