Trial Outcomes & Findings for The Optimal Dosage of Intrathecal Morphine for Peripartum Analgesia (NCT NCT01146457)

Results Overview

Rate of breakthrough pain is the number of episodes of breakthrough pain divided by the number of hours of labor. Time measured from placement of the neuraxial anesthetic, until delivery of the neonate. Because duration of labor is different for all patients, the rate of breakthrough pain per hour is used as the primary outcome.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

83 participants

Primary outcome timeframe

Participants were followed for the duration of delivery, an average of 7 hours

Results posted on

2017-04-25

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Saline: Saline Control	Morphine 25 Morphine 25 micrograms: Active dosage	Morphine 50 Morphine 50 micrograms: Active dosage	Morphine 75 Morphine 75 micrograms: Active dosage	Morphine 100 Morphine 100 micrograms: Active dosage
Overall Study STARTED	19	17	21	13	13
Overall Study COMPLETED	19	17	20	13	13
Overall Study NOT COMPLETED	0	0	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Optimal Dosage of Intrathecal Morphine for Peripartum Analgesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=19 Participants Saline control	Morphine 25 n=17 Participants Morphine 25 micrograms	Morphine 50 n=21 Participants Morphine 50 micrograms	Hine 75 n=13 Participants Morphine 75 micrograms	Morphine 100 n=13 Participants Morphine 100 micrograms	Total n=83 Participants Total of all reporting groups
Age, Continuous	34.3 Years STANDARD_DEVIATION 5.3 • n=5 Participants	31.5 Years STANDARD_DEVIATION 5.3 • n=7 Participants	31.3 Years STANDARD_DEVIATION 6.6 • n=5 Participants	32.5 Years STANDARD_DEVIATION 5.5 • n=4 Participants	32.4 Years STANDARD_DEVIATION 5.7 • n=21 Participants	32.3 Years STANDARD_DEVIATION 5.7 • n=8 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	17 Participants n=7 Participants	21 Participants n=5 Participants	13 Participants n=4 Participants	13 Participants n=21 Participants	83 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: Participants were followed for the duration of delivery, an average of 7 hours

Rate of breakthrough pain is the number of episodes of breakthrough pain divided by the number of hours of labor. Time measured from placement of the neuraxial anesthetic, until delivery of the neonate. Because duration of labor is different for all patients, the rate of breakthrough pain per hour is used as the primary outcome.