Trial Outcomes & Findings for Two Dose Epidural Morphine for Post-cesarean Analgesia (NCT NCT01844206)

Last Updated: 2015-12-23

Results Overview

The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

Up to 48 hours post-operatively

Results posted on

2015-12-23

Participant Flow

Participant milestones

Participant milestones
Measure	Epidural Morphine Group receiving 3mg epidural morphine, 24 hours after the initial dose Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose.	Epidural Saline Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg. Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.
Overall Study STARTED	2	3
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Two Dose Epidural Morphine for Post-cesarean Analgesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epidural Morphine n=2 Participants Group receiving 3mg epidural morphine, 24 hours after the initial dose Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose.	Epidural Saline n=3 Participants Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg. Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.	Total n=5 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 48 hours post-operatively

Population: Data could not be summarized to include in the data table because only 5 out of 140 subjects were enrolled prior to study termination, and no data analysis was carried out. As instructed, we are specifying zero ("0") for the Number of Participants Analyzed in each Arm/Group and leaving the data fields blank.

The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.

Outcome measures

Outcome data not reported

Adverse Events

Epidural Morphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Epidural Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Allison Lee

Columbia University

Phone: 305-582-6077

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place