Trial Outcomes & Findings for Adult Patients Undergoing Open Colectomy MA402S23B303 (NCT NCT01507246)
NCT ID: NCT01507246
Last Updated: 2013-05-08
Results Overview
Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
42 participants
Primary outcome timeframe
Wound closure to time hospital discharge order written or Day 30, whichever is sooner
Results posted on
2013-05-08
Participant Flow
Dates of recruitment Dec 13, 2011 to July 3, 2012
open-label, sequential study with two treatment groups. Patients were to be excluded if they met certain intraoperative exclusion criteria.
Participant milestones
| Measure |
PCA/Opioid Group
Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
|
EXPAREL Group
Group receiving EXPAREL
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
|
Overall Study
COMPLETED
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
PCA/Opioid Group
Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
|
EXPAREL Group
Group receiving EXPAREL
|
|---|---|---|
|
Overall Study
Required different surgical procedures
|
2
|
1
|
Baseline Characteristics
Adult Patients Undergoing Open Colectomy MA402S23B303
Baseline characteristics by cohort
| Measure |
PCA/Opioid Group
n=20 Participants
Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
|
EXPAREL Group
n=22 Participants
Group receiving EXPAREL
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Age Continuous
|
54.1 years
STANDARD_DEVIATION 15.77 • n=93 Participants
|
52.6 years
STANDARD_DEVIATION 17.51 • n=4 Participants
|
53.3 years
STANDARD_DEVIATION 16.53 • n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
22 participants
n=4 Participants
|
42 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Wound closure to time hospital discharge order written or Day 30, whichever is soonerPopulation: Per protocol
Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.
Outcome measures
| Measure |
PCA/Opioid Group
n=18 Participants
Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as need.
|
EXPAREL
n=21 Participants
Group receiving EXPAREL
|
|---|---|---|
|
Total Opioid Burden
|
115.00 mg
Standard Deviation 113.27
|
56.76 mg
Standard Deviation 74.04
|
PRIMARY outcome
Timeframe: Wound closure to time hospital discharge order written or Day 30, whichever is sooner.Population: per protocol
Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.
Outcome measures
| Measure |
PCA/Opioid Group
n=18 Participants
Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as need.
|
EXPAREL
n=21 Participants
Group receiving EXPAREL
|
|---|---|---|
|
Health Economic Benefits - Total Cost of Hospitalization
|
11850.28 dollars
Standard Deviation 6600.90
|
8766.07 dollars
Standard Deviation 1048.95
|
PRIMARY outcome
Timeframe: Up to Day 30Population: All subjects analyzed, no censored events
Length of stay (LOS), recorded in hours and converted to days with one decimal of precision, 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 |
PCA/Opioid Group
n=18 Participants
Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as need.
|
EXPAREL
n=21 Participants
Group receiving EXPAREL
|
|---|---|---|
|
Health Economic Benefits - Length of Stay
|
4.9 days
Interval 3.9 to 6.7
|
2.0 days
Interval 1.9 to 3.0
|
SECONDARY outcome
Timeframe: From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), which ever is soonerPopulation: Per protocol.
The incidence of predefined opioid-related adverse events
Outcome measures
| Measure |
PCA/Opioid Group
n=18 Participants
Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as need.
|
EXPAREL
n=21 Participants
Group receiving EXPAREL
|
|---|---|---|
|
Incidence of Predefined Opioid-related Adverse Events
|
0 Number of patients
|
0 Number of patients
|
Adverse Events
PCA/Opioid Group
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
EXPAREL Group
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PCA/Opioid Group
n=18 participants at risk
Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
|
EXPAREL Group
n=21 participants at risk
Group receiving EXPAREL
|
|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.6%
1/18 • Number of events 1
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
5.6%
1/18 • Number of events 1
|
0.00%
0/21
|
|
Surgical and medical procedures
Wound drainage
|
5.6%
1/18 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/18
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/18
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/18
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
5.6%
1/18 • Number of events 1
|
0.00%
0/21
|
|
Psychiatric disorders
Drug Seeking Behavior
|
0.00%
0/18
|
4.8%
1/21 • Number of events 1
|
Other adverse events
| Measure |
PCA/Opioid Group
n=18 participants at risk
Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
|
EXPAREL Group
n=21 participants at risk
Group receiving EXPAREL
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/18
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/18
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/18
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
5.6%
1/18 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/18
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/18
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/18
|
4.8%
1/21 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post Procedural Hematoma
|
0.00%
0/18
|
4.8%
1/21 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/18
|
4.8%
1/21 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound Evisceration
|
5.6%
1/18 • Number of events 1
|
0.00%
0/21
|
|
Investigations
Blood Creatine Increased
|
5.6%
1/18 • Number of events 1
|
0.00%
0/21
|
|
Investigations
Blood Pressure Increased
|
5.6%
1/18 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.6%
1/18 • Number of events 1
|
0.00%
0/21
|
|
Surgical and medical procedures
Therapy Regimen Changed
|
5.6%
1/18 • Number of events 1
|
0.00%
0/21
|
|
Surgical and medical procedures
Wound Drainage
|
5.6%
1/18 • Number of events 1
|
0.00%
0/21
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place