Trial Outcomes & Findings for Comparing Effectiveness of CSE Versus DPE for Labor Analgesia (NCT NCT05068661)

NCT ID: NCT05068661

Last Updated: 2024-11-06

Results Overview

The primary outcome of this study is block quality which will be defined by a composite of five components (1) asymmetric block after 30 minutes of initiation, (2) top-up interventions, (3) catheter adjustments (4) failed catheter requiring replacement, and (5) failed epidural requiring general anesthesia or replacement neuraxial anesthesia for cesarean section. The presence of any of the components (or more than one) indicates that the outcome occurred.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 101 participants
• Primary outcome timeframe: From placement of epidural to delivery of baby, up to 32 hours
• Results posted on: 2024-11-06

Participant Flow

Participant milestones

Measure	Combined Spinal Epidural 10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space to initiate analgesia. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE Bupivacaine 0.25% Injectable Solution: CSE	Dural Puncture Epidural A 25-G Whitacre needle will be used to puncture the dura. An initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) will be administered. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE
Overall Study STARTED	49	52
Overall Study COMPLETED	48	52
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Effectiveness of CSE Versus DPE for Labor Analgesia

Baseline characteristics by cohort

Measure	Combined Spinal Epidural n=48 Participants 10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space to initiate analgesia. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE Bupivacaine 0.25% Injectable Solution: CSE	Dural Puncture Epidural n=52 Participants A 25-G Whitacre needle will be used to puncture the dura. An initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) will be administered. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE	Total n=100 Participants Total of all reporting groups
Age, Continuous	31 years STANDARD_DEVIATION 5 • n=5 Participants	32 years STANDARD_DEVIATION 4 • n=7 Participants	32 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	52 Participants n=7 Participants	100 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	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants	47 Participants n=7 Participants	88 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	5 Participants n=7 Participants	9 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	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	30 Participants n=7 Participants	59 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	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	48 Participants n=5 Participants	52 Participants n=7 Participants	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: From placement of epidural to delivery of baby, up to 32 hours

The primary outcome of this study is block quality which will be defined by a composite of five components (1) asymmetric block after 30 minutes of initiation, (2) top-up interventions, (3) catheter adjustments (4) failed catheter requiring replacement, and (5) failed epidural requiring general anesthesia or replacement neuraxial anesthesia for cesarean section. The presence of any of the components (or more than one) indicates that the outcome occurred.

Outcome measures

Measure	Combined Spinal Epidural n=48 Participants 10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space to initiate analgesia. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE Bupivacaine 0.25% Injectable Solution: CSE	Dural Puncture Epidural n=52 Participants A 25-G Whitacre needle will be used to puncture the dura. An initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) will be administered. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE
Number of Participants With the Presence of Any of the Five Block Quality Components (or More Than One)	16 Participants	13 Participants

SECONDARY outcome

Timeframe: From placement of epidural to delivery, up to 32 hours

This will include instances such as: hypotension defined as 20% drop in blood pressure from admission blood pressure, fetal bradycardia, PDPH

Outcome measures

Measure	Combined Spinal Epidural n=48 Participants 10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space to initiate analgesia. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE Bupivacaine 0.25% Injectable Solution: CSE	Dural Puncture Epidural n=52 Participants A 25-G Whitacre needle will be used to puncture the dura. An initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) will be administered. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE
Maternal Adverse Events	40 Participants	37 Participants

SECONDARY outcome

Timeframe: From placement of epidural to delivery, up to 32 hours

Motor block is defined as a Bromage score of 1 to 4 on a scale of 1 to 5. 1 = unable flex feet or knees, 2 = able to flex feet only, 3 = able to flex knees, 4 = detectable weakness in hip flexion, 5 = no weakness in hip flexion.

Outcome measures

Measure	Combined Spinal Epidural n=48 Participants 10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space to initiate analgesia. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE Bupivacaine 0.25% Injectable Solution: CSE	Dural Puncture Epidural n=52 Participants A 25-G Whitacre needle will be used to puncture the dura. An initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) will be administered. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE
Number of Participants With Motor Block as Measured by the Modified Bromage Score	13 Participants	10 Participants

SECONDARY outcome

Timeframe: From start of second stage of labor to delivery, up to 6 hours

Time from initiation of pushing to delivery of baby will be recorded

Outcome measures

Measure	Combined Spinal Epidural n=48 Participants 10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space to initiate analgesia. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE Bupivacaine 0.25% Injectable Solution: CSE	Dural Puncture Epidural n=52 Participants A 25-G Whitacre needle will be used to puncture the dura. An initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) will be administered. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE
Duration of the Second Stage of Labor	23 minutes Interval 10.0 to 57.0	47 minutes Interval 20.0 to 97.0

SECONDARY outcome

Timeframe: From placement of epidural to delivery, up to 32 hours

Time from placement of epidural to delivery will be recorded in anesthetic record

Outcome measures

Measure	Combined Spinal Epidural n=48 Participants 10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space to initiate analgesia. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE Bupivacaine 0.25% Injectable Solution: CSE	Dural Puncture Epidural n=52 Participants A 25-G Whitacre needle will be used to puncture the dura. An initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) will be administered. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE
Total Labor Epidural Time	443 Minutes Interval 304.0 to 738.0	534 Minutes Interval 292.0 to 747.0

SECONDARY outcome

Timeframe: From placement of epidural to delivery, up to 32 hours

Total volume of local anesthetic will be recorded.

Outcome measures

Measure	Combined Spinal Epidural n=48 Participants 10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space to initiate analgesia. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE Bupivacaine 0.25% Injectable Solution: CSE	Dural Puncture Epidural n=52 Participants A 25-G Whitacre needle will be used to puncture the dura. An initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) will be administered. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE
Total Anesthetic Dose Required	108 mL Interval 81.0 to 143.0	108 mL Interval 65.0 to 162.0

SECONDARY outcome

Timeframe: From placement of epidural to delivery, up to 32 hours

Outcome measures

Measure	Combined Spinal Epidural n=48 Participants 10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space to initiate analgesia. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE Bupivacaine 0.25% Injectable Solution: CSE	Dural Puncture Epidural n=52 Participants A 25-G Whitacre needle will be used to puncture the dura. An initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) will be administered. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE
Number of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses	40 Participants	41 Participants

SECONDARY outcome

Timeframe: Through completion of the study, up to 32 hours from epidural placement

Spontaneous and assisted deliveries will be recorded

Outcome measures

Measure	Combined Spinal Epidural n=48 Participants 10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space to initiate analgesia. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE Bupivacaine 0.25% Injectable Solution: CSE	Dural Puncture Epidural n=52 Participants A 25-G Whitacre needle will be used to puncture the dura. An initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) will be administered. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE
Mode of Delivery Spontaneous Vaginal Delivery	32 Participants	33 Participants
Mode of Delivery Forceps Assisted Delivery	2 Participants	1 Participants
Mode of Delivery Vacuum Assisted Delivery	1 Participants	0 Participants
Mode of Delivery Cesarean Delivery	13 Participants	18 Participants

SECONDARY outcome

Timeframe: From placement of epidural to delivery, up to 32 hours

Patient satisfaction scores will be recorded from scale of 0 to 10, with 10 being the highest level of satisfaction

Outcome measures

Measure	Combined Spinal Epidural n=48 Participants 10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space to initiate analgesia. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE Bupivacaine 0.25% Injectable Solution: CSE	Dural Puncture Epidural n=52 Participants A 25-G Whitacre needle will be used to puncture the dura. An initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) will be administered. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE
Postpartum: Satisfaction With Analgesia Overall	10 score on a scale (0-10) Interval 8.0 to 10.0	10 score on a scale (0-10) Interval 8.0 to 10.0

Adverse Events

Combined Spinal Epidural

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Dural Puncture Epidural

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Combined Spinal Epidural n=48 participants at risk 10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space to initiate analgesia. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE Bupivacaine 0.25% Injectable Solution: CSE	Dural Puncture Epidural n=52 participants at risk A 25-G Whitacre needle will be used to puncture the dura. An initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) will be administered. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care. Ropivacaine 0.1% Injectable Solution: DPE
Vascular disorders Hypotension	16.7% 8/48 • Number of events 8 • 72 hours	21.2% 11/52 • Number of events 11 • 72 hours
Skin and subcutaneous tissue disorders Pruritus	79.2% 38/48 • Number of events 38 • 72 hours	57.7% 30/52 • Number of events 30 • 72 hours
Gastrointestinal disorders Nausea	27.1% 13/48 • Number of events 13 • 72 hours	30.8% 16/52 • Number of events 16 • 72 hours
Nervous system disorders Postdural Puncture Headache	2.1% 1/48 • Number of events 1 • 72 hours	0.00% 0/52 • 72 hours
Pregnancy, puerperium and perinatal conditions Fetal Heart Rate decelerations	35.4% 17/48 • Number of events 17 • 72 hours	44.2% 23/52 • Number of events 23 • 72 hours

Additional Information

Dr. Ashraf Habib

Duke University School of Medicine

Phone: 9196682024

Email: habib001@mc.duke.edu

Results disclosure agreements

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