Trial Outcomes & Findings for A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy (NCT NCT02058290)
NCT ID: NCT02058290
Last Updated: 2014-05-14
Results Overview
Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
122 participants
Primary outcome timeframe
Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Results posted on
2014-05-14
Participant Flow
Participant milestones
| Measure |
IV Morphine Sulfate or Sponsor-approved Equivalent
Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour.
|
EXPAREL
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
45
|
|
Overall Study
COMPLETED
|
66
|
36
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
Reasons for withdrawal
| Measure |
IV Morphine Sulfate or Sponsor-approved Equivalent
Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour.
|
EXPAREL
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Didn't meet intraoperative criteria
|
8
|
7
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy
Baseline characteristics by cohort
| Measure |
IV Morphine Sulfate or Sponsor-approved Equivalent
n=67 Participants
Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour.
|
EXPAREL
n=38 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 14.35 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 11.86 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 13.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
60 participants
n=5 Participants
|
34 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
American Society of Anesthesiologist (ASA) Classification
Normal [1]
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
American Society of Anesthesiologist (ASA) Classification
Mild Systemic Disease [2]
|
32 participants
n=5 Participants
|
25 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
American Society of Anesthesiologist (ASA) Classification
Severe Systemic Disease [3]
|
32 participants
n=5 Participants
|
13 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
American Society of Anesthesiologist (ASA) Classification
Severe Systemic Disease Threat to Life [4]
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Patient's Pain Level 24 Hours Prior to Surgery
|
1.9 units on a scale
STANDARD_DEVIATION 2.14 • n=5 Participants
|
1.3 units on a scale
STANDARD_DEVIATION 0.86 • n=7 Participants
|
1.7 units on a scale
STANDARD_DEVIATION 1.81 • n=5 Participants
|
PRIMARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.
Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.
Outcome measures
| Measure |
IV Morphine Sulfate or Sponsor-approved Equivalent
n=56 Participants
Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour.
|
EXPAREL
n=26 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed.
|
|---|---|---|
|
Total Opioid Burden
|
96.47 mg
Standard Deviation 77.74
|
32.06 mg
Standard Deviation 53.16
|
PRIMARY outcome
Timeframe: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.Population: Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.
Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever was sooner.
Outcome measures
| Measure |
IV Morphine Sulfate or Sponsor-approved Equivalent
n=56 Participants
Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour.
|
EXPAREL
n=26 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed.
|
|---|---|---|
|
Health Economic Benefits - Total Cost of Hospitalization
|
15158.79 dollars
Standard Deviation 11417.50
|
14802.70 dollars
Standard Deviation 18382.12
|
PRIMARY outcome
Timeframe: Wound closure at time hospital discharge order is written or Day 30, whichever is soonerPopulation: Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.
Length of stay, recorded in days, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.
Outcome measures
| Measure |
IV Morphine Sulfate or Sponsor-approved Equivalent
n=56 Participants
Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour.
|
EXPAREL
n=26 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed.
|
|---|---|---|
|
Health Economic Benefits - Length of Stay (LOS)
|
4.0 days
Interval 0.0 to 30.0
|
3.0 days
Interval 1.9 to 10.7
|
SECONDARY outcome
Timeframe: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.Population: Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.
Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.
Outcome measures
| Measure |
IV Morphine Sulfate or Sponsor-approved Equivalent
n=56 Participants
Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour.
|
EXPAREL
n=26 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed.
|
|---|---|---|
|
Incidence of Opioid-related Adverse Events
|
23 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.Population: Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.
Responses to question pertaining to patient satisfaction with pain treatment
Outcome measures
| Measure |
IV Morphine Sulfate or Sponsor-approved Equivalent
n=56 Participants
Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour.
|
EXPAREL
n=26 Participants
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed.
|
|---|---|---|
|
Patient Satisfaction With Pain Treatment After Surgery
Neither Satisfied nor Dissatisfied
|
0 participants
|
2 participants
|
|
Patient Satisfaction With Pain Treatment After Surgery
Dissatisfied
|
3 participants
|
0 participants
|
|
Patient Satisfaction With Pain Treatment After Surgery
Extremely Satisfied
|
30 participants
|
17 participants
|
|
Patient Satisfaction With Pain Treatment After Surgery
Satisfied
|
19 participants
|
5 participants
|
|
Patient Satisfaction With Pain Treatment After Surgery
Extremely Dissatisfied
|
1 participants
|
0 participants
|
|
Patient Satisfaction With Pain Treatment After Surgery
Not Reported
|
3 participants
|
2 participants
|
Adverse Events
IV Morphine Sulfate or Sponsor-approved Equivalent
Serious events: 9 serious events
Other events: 53 other events
Deaths: 0 deaths
EXPAREL
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IV Morphine Sulfate or Sponsor-approved Equivalent
n=67 participants at risk
Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour.
|
EXPAREL
n=38 participants at risk
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
2.6%
1/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
0.00%
0/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
2.6%
1/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
2.6%
1/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
3.0%
2/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
2.6%
1/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Infections and infestations
Abscess
|
0.00%
0/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
2.6%
1/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
2.6%
1/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Infections and infestations
Bacterial Sepsis
|
0.00%
0/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
2.6%
1/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Infections and infestations
Clostridial Infection
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Infections and infestations
Urinary Tract Infection
|
3.0%
2/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
2.6%
1/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Injury, poisoning and procedural complications
Anastomotic Leak
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
2.6%
1/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
2.6%
1/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
2.6%
1/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
2.6%
1/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Renal and urinary disorders
Urinary Retention
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
2.6%
1/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Surgical and medical procedures
Stent Placement
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Investigations
Blood Urea Nitrogen (BUN) Increased
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Investigations
Blood Creatinine Increased
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Investigations
White Blood Cells Increased
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
Other adverse events
| Measure |
IV Morphine Sulfate or Sponsor-approved Equivalent
n=67 participants at risk
Standard of Care (SOC)
IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour.
|
EXPAREL
n=38 participants at risk
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.
All patients were offered rescue analgesia, as needed.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.0%
4/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
5.3%
2/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.0%
4/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Cardiac disorders
Tachycardia
|
3.0%
2/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
5.3%
2/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Gastrointestinal disorders
Abdominal Distention
|
7.5%
5/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.5%
5/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
5.3%
2/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
3/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
2.6%
1/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Gastrointestinal disorders
Nausea
|
34.3%
23/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
7.9%
3/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
3.0%
2/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
5/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
General disorders
Chest Pain
|
3.0%
2/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
General disorders
Pyrexia
|
3.0%
2/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
2.6%
1/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
5.3%
2/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Infections and infestations
Clostridial Infection
|
3.0%
2/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Infections and infestations
Urinary Tract Infection
|
6.0%
4/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
3.0%
2/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
2.6%
1/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Investigations
Blood Pressure Increased
|
3.0%
2/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.0%
2/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.5%
3/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.5%
1/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
5.3%
2/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.0%
2/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.5%
3/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
3.0%
2/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Nervous system disorders
Headache
|
10.4%
7/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Nervous system disorders
Hypoethesia
|
3.0%
2/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Psychiatric disorders
Confusional State
|
3.0%
2/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Renal and urinary disorders
Urinary Retention
|
7.5%
5/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
3.0%
2/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.5%
3/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
5/67 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
0.00%
0/38 • Through Day 30 post surgery.
Of the 122 subjects enrolled, the safety analysis set included 67 subjects from Group 1 and 38 subjects from Group 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place