Trial Outcomes & Findings for A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B302 (NCT NCT01507233)

Last Updated: 2014-03-06

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

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

Wound closure to time hospital discharge order written or Day 30, whichever is sooner

Results posted on

2014-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	IV Morphine Sulfate morphine sulfate (or Sponsor-approved equivalent) IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour.	EXPAREL EXPAREL (bupivacaine liposome injectable suspension) EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care. All patients will be offered rescue analgesia, as needed.
Overall Study STARTED	5	0
Overall Study COMPLETED	5	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B302

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV Morphine Sulfate n=5 Participants morphine sulfate (or Sponsor-approved equivalent) IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour.	EXPAREL EXPAREL (bupivacaine liposome injectable suspension) EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care. All patients will be offered rescue analgesia, as needed.	Total n=5 Participants Total of all reporting groups
Age, Continuous	53.6 years STANDARD_DEVIATION 13.76 • n=99 Participants	—	53.6 years STANDARD_DEVIATION 13.76 • n=206 Participants
Age, Categorical <=18 years	0 participants n=99 Participants	—	0 participants n=206 Participants
Age, Categorical Between 18 and 65 years	4 participants n=99 Participants	—	4 participants n=206 Participants
Age, Categorical >=65 years	1 participants n=99 Participants	—	1 participants n=206 Participants
Gender Female	3 participants n=99 Participants	—	3 participants n=206 Participants
Gender Male	2 participants n=99 Participants	—	2 participants n=206 Participants
Region of Enrollment United States	5 participants n=99 Participants	—	5 participants n=206 Participants

PRIMARY outcome

Timeframe: Wound closure to time hospital discharge order written or Day 30, whichever is sooner

Population: As no subjects received EXPAREL in this study, statistical analyses were not performed.

Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Wound closure to Day 30

Population: As no subjects received EXPAREL in this study, statistical analyses were not performed.

1. Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner. 2. Length of stay (LOS), recorded in hours, 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

Outcome data not reported

SECONDARY outcome

Timeframe: Wound closure to time hospital discharge order written or Day 30, whichever is sooner.

Population: As no subjects received EXPAREL in this study, statistical analyses were not performed.

1. 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. 2. Responses to one question pertaining to patient satisfaction with postsurgical analgesia and four questions pertaining to postsurgical recovery following hospital discharge.

Outcome measures

Outcome data not reported

Adverse Events

IV Morphine Sulfate

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

EXPAREL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IV Morphine Sulfate n=5 participants at risk morphine sulfate (or Sponsor-approved equivalent) IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour.	EXPAREL EXPAREL (bupivacaine liposome injectable suspension) EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care. All patients will be offered rescue analgesia, as needed.
Infections and infestations Wound infection	20.0% 1/5 • Number of events 1 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
Gastrointestinal disorders Mesenteric vein thrombosis	20.0% 1/5 • Number of events 1 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
Injury, poisoning and procedural complications Postoperative ileus	20.0% 1/5 • Number of events 1 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events

Other adverse events

Additional Information

Keith Candiotti, MD

University of Miama/Jackson Memorial Hospital

Phone: 305-585-5332

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	IV Morphine Sulfate n=5 participants at risk morphine sulfate (or Sponsor-approved equivalent) IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour.	EXPAREL EXPAREL (bupivacaine liposome injectable suspension) EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care. All patients will be offered rescue analgesia, as needed.
Blood and lymphatic system disorders Anemia	20.0% 1/5 • Number of events 1 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
Cardiac disorders Tachycardia	60.0% 3/5 • Number of events 3 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
Investigations Urine output decreased	40.0% 2/5 • Number of events 2 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
Blood and lymphatic system disorders Leukocytosis	40.0% 2/5 • Number of events 2 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
Vascular disorders Hypotension	40.0% 2/5 • Number of events 2 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
General disorders Hyperthermia	20.0% 1/5 • Number of events 1 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
Gastrointestinal disorders Vomiting	40.0% 2/5 • Number of events 2 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
Gastrointestinal disorders Abdominal pain	20.0% 1/5 • Number of events 1 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
Gastrointestinal disorders Nausea	60.0% 3/5 • Number of events 3 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
Metabolism and nutrition disorders Hypocalcemia	40.0% 2/5 • Number of events 2 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
Metabolism and nutrition disorders Hypophosphatemia	20.0% 1/5 • Number of events 1 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
Injury, poisoning and procedural complications Anemia post-operative	20.0% 1/5 • Number of events 1 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
Metabolism and nutrition disorders Hyponatremia	40.0% 2/5 • Number of events 2 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	20.0% 1/5 • Number of events 1 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
Gastrointestinal disorders Hiccups	20.0% 1/5 • Number of events 1 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events
General disorders Pyrexia	20.0% 1/5 • Number of events 1 • 30 days post surgery normal systematic assessment of adverse events	— 0/0 • 30 days post surgery normal systematic assessment of adverse events