Trial Outcomes & Findings for 2 Dose Neuraxial Morphine for Prevention of PDPH (NCT NCT02473276)
NCT ID: NCT02473276
Last Updated: 2025-02-05
Results Overview
The primary outcome will be the incidence of postdural puncture headache at 48 hours after accidental dural puncture. This will be determined by a face to face questionnaire and the severity of headache will be rated according to a verbal rating scale (0 -10).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
44 participants
Primary outcome timeframe
48 hours after accidental dural puncture
Results posted on
2025-02-05
Participant Flow
Participant milestones
| Measure |
EPID PFM
The group "EPID PFM" will receive 3 mg (6 ml) of preservative-free morphine, followed by 3 mL of sterile normal saline, to be administered through the epidural catheter. 16 to 24 hours after receiving the first dose, the patient will then receive 3 mg (6 ml) of preservative-free morphine (for a total of two doses).
|
EPID SAL
The placebo group, "EPID NS", will receive 6 mL of sterile normal saline via the epidural catheter followed by another 3 mL sterile normal saline. 16 to 24 hours after receiving the first dose, the patient will then receive 6 mL of sterile normal saline (for a total of two doses).
|
IT PFM
The group, "IT PFM" will receive 200 micrograms (mcg) (0.4 mL) of preservative-free morphine via the intrathecal catheter, followed by a flush of the catheter with 2 mL of sterile normal saline. 16 to 24 hours after receiving the first dose, the patient will then receive 200 mcg (0.4 mL) of preservative-free morphine (for a total of two doses).
|
IT SAL
The placebo group IT SAL will receive 0.4 mL and then 2 mL of sterile normal saline through the intrathecal catheter. 16 to 24 hours after receiving the first dose, the patient will then receive 0.4 mL and then 2 mL of sterile normal saline (for a total of two doses).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
11
|
15
|
|
Overall Study
COMPLETED
|
8
|
10
|
11
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 Dose Neuraxial Morphine for Prevention of PDPH
Baseline characteristics by cohort
| Measure |
EPID PFM
n=8 Participants
The group "EPID PFM" will receive 3 mg (6 ml) of preservative-free morphine, followed by 3 mL of sterile normal saline, to be administered through the epidural catheter. 16 to 24 hours after receiving the first dose, the patient will then receive 3 mg (6 ml) of preservative-free morphine (for a total of two doses).
|
EPID SAL
n=10 Participants
The placebo group, "EPID NS", will receive 6 mL of sterile normal saline via the epidural catheter followed by another 3 mL sterile normal saline. 16 to 24 hours after receiving the first dose, the patient will then receive 6 mL of sterile normal saline (for a total of two doses).
|
IT PFM
n=11 Participants
The group, "IT PFM" will receive 200 micrograms (mcg) (0.4 mL) of preservative-free morphine via the intrathecal catheter, followed by a flush of the catheter with 2 mL of sterile normal saline. 16 to 24 hours after receiving the first dose, the patient will then receive 200 mcg (0.4 mL) of preservative-free morphine (for a total of two doses).
|
IT SAL
n=15 Participants
The placebo group IT SAL will receive 0.4 mL and then 2 mL of sterile normal saline through the intrathecal catheter. 16 to 24 hours after receiving the first dose, the patient will then receive 0.4 mL and then 2 mL of sterile normal saline (for a total of two doses).
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.9 years
STANDARD_DEVIATION 2.6 • n=99 Participants
|
31 years
STANDARD_DEVIATION 5.5 • n=107 Participants
|
31.1 years
STANDARD_DEVIATION 5.8 • n=206 Participants
|
32.9 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
32.1 years
STANDARD_DEVIATION 5.4 • n=31 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
44 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
10 participants
n=107 Participants
|
11 participants
n=206 Participants
|
15 participants
n=7 Participants
|
44 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 48 hours after accidental dural punctureThe primary outcome will be the incidence of postdural puncture headache at 48 hours after accidental dural puncture. This will be determined by a face to face questionnaire and the severity of headache will be rated according to a verbal rating scale (0 -10).
Outcome measures
| Measure |
EPID PFM
n=8 Participants
The group "EPID PFM" will receive 3 mg (6 ml) of preservative-free morphine, followed by 3 mL of sterile normal saline, to be administered through the epidural catheter. 16 to 24 hours after receiving the first dose, the patient will then receive 3 mg (6 ml) of preservative-free morphine (for a total of two doses).
|
EPID SAL
n=10 Participants
The placebo group, "EPID NS", will receive 6 mL of sterile normal saline via the epidural catheter followed by another 3 mL sterile normal saline. 16 to 24 hours after receiving the first dose, the patient will then receive 6 mL of sterile normal saline (for a total of two doses).
|
IT PFM
n=11 Participants
The group, "IT PFM" will receive 200 micrograms (mcg) (0.4 mL) of preservative-free morphine via the intrathecal catheter, followed by a flush of the catheter with 2 mL of sterile normal saline. 16 to 24 hours after receiving the first dose, the patient will then receive 200 mcg (0.4 mL) of preservative-free morphine (for a total of two doses).
|
IT SAL
n=15 Participants
The placebo group IT SAL will receive 0.4 mL and then 2 mL of sterile normal saline through the intrathecal catheter. 16 to 24 hours after receiving the first dose, the patient will then receive 0.4 mL and then 2 mL of sterile normal saline (for a total of two doses).
|
|---|---|---|---|---|
|
Number of Participants With Postdural Puncture Headache
|
3 Participants
|
4 Participants
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 48 hours after accidental dural punctureA secondary outcome will be the need for epidural blood patch at 48 hours after accidental dural puncture. This will be recorded on the study data collection sheet.
Outcome measures
| Measure |
EPID PFM
n=8 Participants
The group "EPID PFM" will receive 3 mg (6 ml) of preservative-free morphine, followed by 3 mL of sterile normal saline, to be administered through the epidural catheter. 16 to 24 hours after receiving the first dose, the patient will then receive 3 mg (6 ml) of preservative-free morphine (for a total of two doses).
|
EPID SAL
n=10 Participants
The placebo group, "EPID NS", will receive 6 mL of sterile normal saline via the epidural catheter followed by another 3 mL sterile normal saline. 16 to 24 hours after receiving the first dose, the patient will then receive 6 mL of sterile normal saline (for a total of two doses).
|
IT PFM
n=11 Participants
The group, "IT PFM" will receive 200 micrograms (mcg) (0.4 mL) of preservative-free morphine via the intrathecal catheter, followed by a flush of the catheter with 2 mL of sterile normal saline. 16 to 24 hours after receiving the first dose, the patient will then receive 200 mcg (0.4 mL) of preservative-free morphine (for a total of two doses).
|
IT SAL
n=15 Participants
The placebo group IT SAL will receive 0.4 mL and then 2 mL of sterile normal saline through the intrathecal catheter. 16 to 24 hours after receiving the first dose, the patient will then receive 0.4 mL and then 2 mL of sterile normal saline (for a total of two doses).
|
|---|---|---|---|---|
|
Number of Participants in Need for Epidural Blood Patch
|
2 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
Adverse Events
EPID PFM
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
EPID SAL
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
IT PFM
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
IT SAL
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EPID PFM
n=8 participants at risk
The group "EPID PFM" will receive 3 mg (6 ml) of preservative-free morphine, followed by 3 mL of sterile normal saline, to be administered through the epidural catheter. 16 to 24 hours after receiving the first dose, the patient will then receive 3 mg (6 ml) of preservative-free morphine (for a total of two doses).
|
EPID SAL
n=10 participants at risk
The placebo group, "EPID NS", will receive 6 mL of sterile normal saline via the epidural catheter followed by another 3 mL sterile normal saline. 16 to 24 hours after receiving the first dose, the patient will then receive 6 mL of sterile normal saline (for a total of two doses).
|
IT PFM
n=11 participants at risk
The group, "IT PFM" will receive 200 micrograms (mcg) (0.4 mL) of preservative-free morphine via the intrathecal catheter, followed by a flush of the catheter with 2 mL of sterile normal saline. 16 to 24 hours after receiving the first dose, the patient will then receive 200 mcg (0.4 mL) of preservative-free morphine (for a total of two doses).
|
IT SAL
n=15 participants at risk
The placebo group IT SAL will receive 0.4 mL and then 2 mL of sterile normal saline through the intrathecal catheter. 16 to 24 hours after receiving the first dose, the patient will then receive 0.4 mL and then 2 mL of sterile normal saline (for a total of two doses).
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Postdural Puncture Headache
|
37.5%
3/8 • 48 hours after accidental dural puncture
|
40.0%
4/10 • 48 hours after accidental dural puncture
|
72.7%
8/11 • 48 hours after accidental dural puncture
|
66.7%
10/15 • 48 hours after accidental dural puncture
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place