Trial Outcomes & Findings for A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301 (NCT NCT01507220)

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

2 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	Morphine Sulfate morphine sulfate (or Sponsor-approved equivalent) morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) 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. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump.	EXPAREL EXPAREL (bupivacaine liposome extended-release injectable suspension) bupivacaine liposome extended-release 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 will be given at the end of surgery. If not indicated, an IV 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	2	0
Overall Study COMPLETED	2	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 MA402S23B301

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Morphine Sulfate n=2 Participants morphine sulfate (or Sponsor-approved equivalent) morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) 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. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump.	EXPAREL EXPAREL (bupivacaine liposome extended-release injectable suspension) bupivacaine liposome extended-release 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 will be given at the end of surgery. If not indicated, an IV 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=2 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 12.02 • n=5 Participants	—	51.5 years STANDARD_DEVIATION 12.02 • n=5 Participants
Age, Categorical <=18 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 participants n=5 Participants	—	2 participants n=5 Participants
Age, Categorical >=65 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Gender Female	1 participants n=5 Participants	—	1 participants n=5 Participants
Gender Male	1 participants n=5 Participants	—	1 participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	—	2 participants n=5 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 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. Total cost of hospitalization to 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: From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner

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

Incidence of opioid-related adverse events is defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus. .

Outcome measures

Outcome measures
Measure	Morphine Sulfate n=2 Participants morphine sulfate (or Sponsor-approved equivalent) morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) 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. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump.	EXPAREL EXPAREL (bupivacaine liposome extended-release injectable suspension) bupivacaine liposome extended-release 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 will be given at the end of surgery. If not indicated, an IV 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.
Incidence of Opioid-related Adverse Events	10 Adverse events	—

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), whichever is sooner

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

Responses to one question pertaining to patient satisfaction with postsurgical pain management and four questions pertaining to postsurgical recovery following hospital discharge.

Outcome measures

Outcome data not reported

Adverse Events

Morphine Sulfate

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

EXPAREL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Morphine Sulfate n=2 participants at risk morphine sulfate (or Sponsor-approved equivalent) morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) 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. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump.	EXPAREL EXPAREL (bupivacaine liposome extended-release injectable suspension) bupivacaine liposome extended-release 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 will be given at the end of surgery. If not indicated, an IV 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.
Gastrointestinal disorders Abdominal Pain	50.0% 1/2 • Number of events 2 • 30 days after surgery Normal systematic assessment of adverse events	— 0/0 • 30 days after surgery Normal systematic assessment of adverse events
Gastrointestinal disorders Nausea	50.0% 1/2 • Number of events 2 • 30 days after surgery Normal systematic assessment of adverse events	— 0/0 • 30 days after surgery Normal systematic assessment of adverse events
Gastrointestinal disorders Vomiting	100.0% 2/2 • Number of events 3 • 30 days after surgery Normal systematic assessment of adverse events	— 0/0 • 30 days after surgery Normal systematic assessment of adverse events
Investigations Oxygen Saturation Decreased	50.0% 1/2 • Number of events 1 • 30 days after surgery Normal systematic assessment of adverse events	— 0/0 • 30 days after surgery Normal systematic assessment of adverse events
Cardiac disorders Tachycardia	50.0% 1/2 • Number of events 1 • 30 days after surgery Normal systematic assessment of adverse events	— 0/0 • 30 days after surgery Normal systematic assessment of adverse events
General disorders Pyrexia	50.0% 1/2 • Number of events 1 • 30 days after surgery Normal systematic assessment of adverse events	— 0/0 • 30 days after surgery Normal systematic assessment of adverse events

Additional Information

Sergio Bergese, MD

The Ohio State University

Phone: (614) 293-9027

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place