Trial Outcomes & Findings for Dural Puncture Epidural Versus Epidural Anesthesia for Cesarean Delivery (NCT NCT03915574)

Results Overview

The primary outcome will be the onset time of surgical anesthesia in seconds. This will be measured from the induction of anesthesia (as defined by the beginning of injection of the "Induction 1 syringe") to the point at which sharp sensation is lost bilaterally at the T6 dermatomal level (as measured by a blunt plastic neurotip® (Owen Mumford, USA) device)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

280 participants

Primary outcome timeframe

2 hours

Results posted on

2023-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	Dural Puncture Epidural Participants will receive a dural puncture epidural block with a 25 gauge spinal needle and a loading dose of 10 - 20 ml of 0.0625% bupivacaine + 2mcg/ml fentanyl, followed by an epidural infusion of the same medications 25G Dural Puncture Epidural: Dural puncture created with a 25 gauge spinal needle	Standard Epidural Participants will receive a standard epidural and a loading dose of 10 - 20 ml of 0.0625% bupivacaine + 2mcg/ml fentanyl, followed by an epidural infusion of the same medications Standard Epidural: Control group - standard epidural (no dural puncture)
Overall Study STARTED	70	70
Overall Study COMPLETED	70	66
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dural Puncture Epidural n=70 Participants Participants will receive a dural puncture epidural block with a 25 gauge spinal needle followed by a standard epidural infusion (0.0625% bupivacaine + 2mcg/ml fentanyl) 25G Dural Puncture Epidural: Dural puncture created with a 25 gauge spinal needle	Standard Epidural n=70 Participants Participants will have standard epidural infusion followed by a standard epidural infusion (0.0625% bupivacaine + 2mcg/ml fentanyl) Standard Epidural: Control group - standard epidural (no dural puncture)	Total n=140 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=70 Participants	0 Participants n=70 Participants	0 Participants n=140 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=70 Participants	70 Participants n=70 Participants	140 Participants n=140 Participants
Age, Categorical >=65 years	0 Participants n=70 Participants	0 Participants n=70 Participants	0 Participants n=140 Participants
Age, Continuous	29.1 years STANDARD_DEVIATION 5.3 • n=70 Participants	31 years STANDARD_DEVIATION 5.1 • n=70 Participants	30.1 years STANDARD_DEVIATION 5.2 • n=140 Participants
Sex: Female, Male Female	70 Participants n=70 Participants	70 Participants n=70 Participants	140 Participants n=140 Participants
Sex: Female, Male Male	0 Participants n=70 Participants	0 Participants n=70 Participants	0 Participants n=140 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=70 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants	0 Participants n=66 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants	0 Participants n=136 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants
Race (NIH/OMB) Asian	0 Participants n=70 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants	0 Participants n=66 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants	0 Participants n=136 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=70 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants	0 Participants n=66 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants	0 Participants n=136 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants
Race (NIH/OMB) Black or African American	27 Participants n=70 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants	19 Participants n=66 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants	46 Participants n=136 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants
Race (NIH/OMB) White	40 Participants n=70 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants	45 Participants n=66 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants	85 Participants n=136 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants
Race (NIH/OMB) More than one race	0 Participants n=70 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants	2 Participants n=66 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants	2 Participants n=136 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=70 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants	0 Participants n=66 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants	3 Participants n=136 Participants • 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants
Body Mass Index	33.9 kg/m^2 STANDARD_DEVIATION 6.4 • n=70 Participants	32.9 kg/m^2 STANDARD_DEVIATION 4.9 • n=70 Participants	33.4 kg/m^2 STANDARD_DEVIATION 5.65 • n=140 Participants

PRIMARY outcome

Timeframe: 2 hours

The primary outcome will be the onset time of surgical anesthesia in seconds. This will be measured from the induction of anesthesia (as defined by the beginning of injection of the "Induction 1 syringe") to the point at which sharp sensation is lost bilaterally at the T6 dermatomal level (as measured by a blunt plastic neurotip® (Owen Mumford, USA) device)

Outcome measures

Outcome measures
Measure	Dural Puncture Epidural n=70 Participants Participants will receive a dural puncture epidural block with a 25 gauge spinal needle and a loading dose of 10 - 20 ml of 0.0625% bupivacaine + 2mcg/ml fentanyl, followed by an epidural infusion of the same medications 25G Dural Puncture Epidural: Dural puncture created with a 25 gauge spinal needle	Standard Epidural n=66 Participants Participants will receive a standard epidural and a loading dose of 10 - 20 ml of 0.0625% bupivacaine + 2mcg/ml fentanyl, followed by an epidural infusion of the same medications Standard Epidural: Control group - standard epidural (no dural puncture)
Onset Time of Surgical Anesthesia	422 seconds Interval 290.0 to 546.0	655 seconds Interval 437.0 to 926.0

SECONDARY outcome

Timeframe: 2 hours

A composite outcome defined by failure to achieve at least a T10 bilateral sensory level pre-operatively (after 3 ml 1.5% lidocaine with 1:200,000 epinephrine 45 mg lidocaine and up to 20 ml of 0.0625% bupivacaine with 2mcg/ml fentanyl), the requirement for intraoperative analgesia supplementation, conversion to general anesthesia or repeat neuraxial procedure, or failure to achieve the primary outcome within 15 minutes between the two groups. Analyzed as a collapsed composite (any or none)

Outcome measures

Outcome measures
Measure	Dural Puncture Epidural n=70 Participants Participants will receive a dural puncture epidural block with a 25 gauge spinal needle and a loading dose of 10 - 20 ml of 0.0625% bupivacaine + 2mcg/ml fentanyl, followed by an epidural infusion of the same medications 25G Dural Puncture Epidural: Dural puncture created with a 25 gauge spinal needle	Standard Epidural n=66 Participants Participants will receive a standard epidural and a loading dose of 10 - 20 ml of 0.0625% bupivacaine + 2mcg/ml fentanyl, followed by an epidural infusion of the same medications Standard Epidural: Control group - standard epidural (no dural puncture)
Number of Participants With Inadequate Neuraxial Analgesia or Anesthesia	11 Participants	24 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 hours

Maximum pain visual analogue scale during surgery (units on a scale, 0 - 10)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 hours

Vasopressor requirements during surgery required to maintain systolic blood pressure within 15% of baseline

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 hours

Overall patient satisfaction score (units on a scale, 0 - 10)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 hours

Neonatal Apgar scores (units on a scale, 0 - 10)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 hours

Umbilical cord blood gases (pH measurement)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

Opioid consumption measured in milligrams.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 hours

nausea, vomiting, itching (yes/no)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 hours

measured in milligrams

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 hours

Motor block assessment 0 - Able to move hip, knee, and ankle 1. \- unable to move hip, but able to move knee and ankle 2. \- unable to move hip and knee, but able to move ankle 3. \- unable to move hip, knee and ankle

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 hours

Assessed using sharp sensation at the midclavicular line on the abdomen and thorax Reported at the dermatomal level where sharp sensation is first felt

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

Accidental dural puncture, local anesthesia systemic toxicity, high spinal, post dural puncture headache

Outcome measures

Outcome data not reported

Adverse Events

Dural Puncture Epidural

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Epidural

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

Nadir Sharawi

UAMS

Phone: 5016866119

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place