Trial Outcomes & Findings for Incidence of Headache Following an Unintentional Dural Puncture (NCT NCT01977898)

NCT ID: NCT01977898

Last Updated: 2021-11-17

Results Overview

Participants who report post dural puncture headaches from delivery to postpartum day 5

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 68 participants
• Primary outcome timeframe: 5 days
• Results posted on: 2021-11-17

Participant Flow

68 were consented to participate in the study . 2 withdrew and 3 were excluded for non-functional catheter.

Participant milestones

Measure	Morphine Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.	Saline Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Overall Study STARTED	28	35
Overall Study COMPLETED	27	34
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Morphine Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.	Saline Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Overall Study Non functioning catheter	1	1

Baseline Characteristics

Incidence of Headache Following an Unintentional Dural Puncture

Baseline characteristics by cohort

Measure	Morphine n=27 Participants Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.	Saline n=34 Participants Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.	Total n=61 Participants Total of all reporting groups
Age, Continuous	33 Years n=5 Participants	32 Years n=7 Participants	32 Years n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	34 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	34 participants n=7 Participants	61 participants n=5 Participants
Ethnicity Hispanic (ethnicity)	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity Non-hispanic (ethnicity)	20 Participants n=5 Participants	31 Participants n=7 Participants	51 Participants n=5 Participants
Body Mass Index (kg/m^2)	29.1 kg/m^2 n=5 Participants	28.9 kg/m^2 n=7 Participants	29.0 kg/m^2 n=5 Participants
Nulliparous	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Gestational age (weeks)	39 Weeks n=5 Participants	39 Weeks n=7 Participants	39 Weeks n=5 Participants
Loss of resistance method Air	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Loss of resistance method Saline	11 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants
Intrathecal catheter depth (cm) Insertion	11 Centimeters (cm) n=5 Participants	11 Centimeters (cm) n=7 Participants	11 Centimeters (cm) n=5 Participants
Intrathecal catheter depth (cm) Removal	11 Centimeters (cm) n=5 Participants	11 Centimeters (cm) n=7 Participants	11 Centimeters (cm) n=5 Participants
Unable to aspirate prior to administering study drug (n)	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Participants who report post dural puncture headaches from delivery to postpartum day 5

Outcome measures

Measure	Morphine n=27 Participants Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.	Saline n=34 Participants Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Participants Who Report Post Dural Puncture Headaches	21 Participants	27 Participants

SECONDARY outcome

Timeframe: Time of unintentional dural puncture to postpartum day 5

Population: 21 in the morphine group and 27 in the saline group experienced headaches.

Severity of post dural puncture headache on a numerical rating scale 0= no pain and 10= worst pain imaginable from the time of delivery to postpartum day 5.

Outcome measures

Measure	Morphine n=21 Participants Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.	Saline n=27 Participants Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Severity of Post Dural Puncture Headache	7 score on a scale Interval 3.0 to 8.5	7.5 score on a scale Interval 5.0 to 8.0

SECONDARY outcome

Timeframe: Unintentional dural puncture - Postpartum day 5

Population: 21 in the morphine group and 27 in the saline group experienced unintentional post dural puncture headaches.

Treatment method completed for unintentional dural puncture headache.

Outcome measures

Measure	Morphine n=21 Participants Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.	Saline n=27 Participants Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Treatment Method for Headache Epidural blood patch	11 Participants	10 Participants
Treatment Method for Headache Oral analgesics	9 Participants	16 Participants
Treatment Method for Headache Hydration	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 5 days

Population: 21 in the morphine group and 27 in the saline group experienced unintentional dural puncture headaches.

The number of participants who experience cranial nerve symptoms up to 5 days after the unintentional dural puncture.

Outcome measures

Measure	Morphine n=21 Participants Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.	Saline n=27 Participants Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Number of Participants With Cranial Nerve Symptoms None	13 Participants	24 Participants
Number of Participants With Cranial Nerve Symptoms Visual	1 Participants	0 Participants
Number of Participants With Cranial Nerve Symptoms Auditory	7 Participants	3 Participants

SECONDARY outcome

Timeframe: After first epidural blood patch to 5 days after delivery

Repeated epidural blood patch for headache pain after unintentional dural puncture.

Outcome measures

Measure	Morphine n=11 Participants Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.	Saline n=10 Participants Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Repeat Epidural Blood Patch	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Dural puncture to 5 days after delivery

Population: 21 in the morphine group and 27 in the saline group experienced headache after unintentional dural puncture.

Presenting day of headache after unintentional dural puncture

Outcome measures

Measure	Morphine n=21 Participants Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.	Saline n=27 Participants Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Presenting Day of Headache Day 1	9 Participants	11 Participants
Presenting Day of Headache Day 2	8 Participants	8 Participants
Presenting Day of Headache Day 3	1 Participants	4 Participants
Presenting Day of Headache Day 4	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 5 days

Population: 21 in the morphine group and 27 in the saline group experienced headache after unintentional dural puncture.

The duration in days of headaches the participants experience after an unintentional dural puncture

Outcome measures

Measure	Morphine n=21 Participants Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.	Saline n=27 Participants Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Number of Participants With Duration in Days of Headache After Unintentional Dural Puncture. 1 day	4 Participants	8 Participants
Number of Participants With Duration in Days of Headache After Unintentional Dural Puncture. 2 day	5 Participants	9 Participants
Number of Participants With Duration in Days of Headache After Unintentional Dural Puncture. 3 day	7 Participants	4 Participants
Number of Participants With Duration in Days of Headache After Unintentional Dural Puncture. 4 day	4 Participants	5 Participants
Number of Participants With Duration in Days of Headache After Unintentional Dural Puncture. 5 day	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 5 days

Population: 21 in the morphine group and 27 in the saline group experienced unintentional post dural puncture headache.

Greatest reported headache pain associated with unintentional dural puncture reported on a scale of 0= no pain to 10= worst pain imaginable.

Outcome measures

Measure	Morphine n=21 Participants Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.	Saline n=27 Participants Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Greatest Level of Headache Pain Experienced With the Unintentional Dural Puncture	7 Score on a scale (0=no pain to 10 worst) Interval 3.0 to 8.5	7.5 Score on a scale (0=no pain to 10 worst) Interval 5.0 to 8.0

SECONDARY outcome

Timeframe: Insertion time to removal in minutes

Intrathecal catheter dwell time(time from insertion to time of removal in minutes).

Outcome measures

Measure	Morphine n=27 Participants Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.	Saline n=34 Participants Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Intrathecal Catheter Dwell Time	418 Insertion to removal time in minutes Interval 291.0 to 550.0	427 Insertion to removal time in minutes Interval 286.0 to 540.0

SECONDARY outcome

Timeframe: Time of insertion of catheter to time catheter removed

Intrathecal infusion volume in milliliters

Outcome measures

Measure	Morphine n=27 Participants Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.	Saline n=34 Participants Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Intrathecal Infusion Volume	12.9 Milliters Interval 8.0 to 19.0	16.2 Milliters Interval 6.9 to 27.0

SECONDARY outcome

Timeframe: up to 10 hours after intrathecal catheter placed

Mode of delivery of the baby (vaginal delivery or instrumented vaginal delivery)

Outcome measures

Measure	Morphine n=27 Participants Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.	Saline n=34 Participants Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Mode of Delivery Vaginal Delivery	24 Participants	29 Participants
Mode of Delivery Instrumented Vaginal Delivery	3 Participants	5 Participants

Adverse Events

Morphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Measure	Morphine n=27 participants at risk Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally. Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.	Saline n=34 participants at risk Patients randomized to the control group will receive normal saline 0.3 mL intrathecally. Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Gastrointestinal disorders New onset nausea	0.00% 0/27 • 5 days after delivery of baby.	0.00% 0/34 • 5 days after delivery of baby.
Gastrointestinal disorders New onset vomiting	0.00% 0/27 • 5 days after delivery of baby.	0.00% 0/34 • 5 days after delivery of baby.

Additional Information

Feyce Peralta, MD

Northwestern University

Phone: 312-472-3585

Email: f-peralta@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place