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This study will compare two anesthetics techniques called Dural Puncture Epidural (DPE) and Standard Epidural as to which of the two can provide faster and potentially better at providing pain relief for cesarean sections. It will also compare these two anesthetics techniques on the percentage of women who require additional drugs to control pain during their cesarean deliveries. The results of this study will help anesthesiologists know which anesthetic technique can provide faster and potentially better at providing pain relief for cesarean sections.
The aim of this study is to compare the onset time of anesthesia between standard epidural and Dural Puncture Epidural (DPE) for cesarean delivery. The study will hypothesize that a DPE technique with a 25-gauge spinal needle will have a faster onset and improved quality of surgical anesthesia when compared to a standard epidural. Participants will be blinded to which group they are being assigned. An unblinded anesthesiologist will insert the epidural or DPE based on randomization. After insertion of the epidural or DPE, a low dose local anesthetic infusion will be infused into the epidural catheter up until the time of surgery. This is the standard infusion used to provide pain relief in laboring women (bupivacaine 0.0625% with 2 mcg/ml fentanyl). In this way participants enrolled in the study would mimic anesthetic the conditions of a "labor epidural".
Participants will then move on to the next phase of the study. In this phase, the epidural pump will be discontinued, and anesthesia care will be conducted in the same manner as all cesarean deliveries under epidural extension anesthesia (this refers to the process of providing anesthesia using a pre-existing epidural/DPE that was inserted for the purpose of providing labor analgesia). Anesthesia will be induced in a standardized manner with 20 ml of 3% chloroprocaine. Motor and sensory block will be tested at the end of the epidural loading dose. Loss of sharp sensation will be measured using a blunt plastic neurotip® (Owen Mumford, USA) until a sensory bilateral block to the T6 dermatomal level has been reached. The T6 level measured at the xiphoid process will be marked bilaterally with a washable marker pen to guarantee the precision of the primary endpoint (which will be assumed when sensory block goes above T6). Sensory testing will be performed from caudad to cephalad (i.e. from blocked to unblocked dermatomes) to identify the first unblocked dermatome. To identify the level where the sensation of touch is first appreciated, the investigator will ask the question: "Tell me when you feel the sensation of something sharp touching your skin." Both the motor and sensory block evaluations are part of the standard clinical care of patients receiving neuraxial anesthesia. The main difference for participants enrolled in the study is that the frequency of sensory assessments will be increased so that the onset of surgical anesthesia can be accurately documented (approximately every minute and then more frequently as the sensory block approaches the primary endpoints). A second anesthesiologist, blind to the type of block will manage the clinical care of the patient from the beginning of the study (after epidural catheter placement) and will administer the induction drug (prepared by that anesthesiologist as per SOC). There will be no difference in this clinician's care of the subject than if she were not enrolled in the study. This will assess the onset of anesthesia and manage all aspects of the subject's clinical care including the documentation of the local anesthetic (LA) solution administration timing and its clinical effects. The speed of onset will be assessed from the end of epidural test dose. This will be defined as time zero and the start of anesthesia. If required, intra-operative analgesia will be offered in the form of further epidural top-up, intravenous fentanyl, ketamine, nitrous oxide or replacement of neuraxial anesthesia/conversion into general anesthesia as the standard of care (SOC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dural Puncture Epidural | Experimental | 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) |
|
| Standard Epidural | Active Comparator | Participants will have standard epidural infusion followed by a standard epidural infusion (0.0625% bupivacaine + 2mcg/ml fentanyl) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25G Dural Puncture Epidural | Device | Dural puncture created with a 25 gauge spinal needle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Onset Time of Surgical Anesthesia | 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) | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Inadequate Neuraxial Analgesia or Anesthesia | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Pain During Surgery (Score) | Maximum pain visual analogue scale during surgery (units on a scale, 0 - 10) | 2 hours |
| Cumulative Dose of Phenylephrine Measured in Milligram Required During Surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadir Sharawi, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37526934 | Derived | Sharawi N, Williams M, Athar W, Martinello C, Stoner K, Taylor C, Guo N, Sultan P, Mhyre JM. Effect of Dural-Puncture Epidural vs Standard Epidural for Epidural Extension on Onset Time of Surgical Anesthesia in Elective Cesarean Delivery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2326710. doi: 10.1001/jamanetworkopen.2023.26710. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
70 mother-infant dyads per arm, Baseline characteristics not collected for infants, Infants were not monitored for adverse events
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| ID | Title | Description |
|---|---|---|
| BG000 | Dural Puncture Epidural | 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 |
| BG001 | Standard Epidural |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Onset Time of Surgical Anesthesia | 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) | Posted | Median | Inter-Quartile Range | seconds | 2 hours |
|
3 days
Infants were not monitored for adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nadir Sharawi | UAMS | 5016866119 | nelsharawi@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2022 | Nov 3, 2023 | Prot_SAP_001.pdf |
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140 mother-infant dyads (280 actual participants)
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| Standard Epidural | Device | Control group - standard epidural (no dural puncture) |
|
| 2 hours |
Vasopressor requirements during surgery required to maintain systolic blood pressure within 15% of baseline
| 2 hours |
| Patient Satisfaction With Anesthetic Technique (Score) | Overall patient satisfaction score (units on a scale, 0 - 10) | 4 hours |
| Neonatal Requirement for Resuscitation | Neonatal Apgar scores (units on a scale, 0 - 10) | 2 hours |
| Neonatal Physiological Condition | Umbilical cord blood gases (pH measurement) | 2 hours |
| Requirement for Opioids in the First 24 Hours After Surgery | Opioid consumption measured in milligrams. | 24 hours |
| Anesthesia Side Effects | nausea, vomiting, itching (yes/no) | 2 hours |
| Vasopressor Requirements During Surgery | measured in milligrams | 2 hours |
| Bromage Score (0 - 3 Scale) | Motor block assessment 0 - Able to move hip, knee, and ankle
| 3 hours |
| Sensory Block Assessment | Assessed using sharp sensation at the midclavicular line on the abdomen and thorax Reported at the dermatomal level where sharp sensation is first felt | 3 hours |
| Anesthesia Adverse Effects | Accidental dural puncture, local anesthesia systemic toxicity, high spinal, post dural puncture headache | 24 hours |
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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | 4 participants in the Standard Epidural Arm did not receive the allocated intervention, so Race data was not collected for 4 participants | Count of Participants | Participants |
|
| Body Mass Index | Body Mass Index is calculated as weight in kilograms divided by height in meters squared | Mean | Standard Deviation | kg/m^2 |
|
| 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) |
|
|
| Secondary | Number of Participants With Inadequate Neuraxial Analgesia or Anesthesia | 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) | Posted | Count of Participants | Participants | 2 hours |
|
|
|
| Other Pre-specified | Maximum Pain During Surgery (Score) | Maximum pain visual analogue scale during surgery (units on a scale, 0 - 10) | Not Posted | 2 hours | Participants |
| Other Pre-specified | Cumulative Dose of Phenylephrine Measured in Milligram Required During Surgery | Vasopressor requirements during surgery required to maintain systolic blood pressure within 15% of baseline | Not Posted | 2 hours | Participants |
| Other Pre-specified | Patient Satisfaction With Anesthetic Technique (Score) | Overall patient satisfaction score (units on a scale, 0 - 10) | Not Posted | 4 hours | Participants |
| Other Pre-specified | Neonatal Requirement for Resuscitation | Neonatal Apgar scores (units on a scale, 0 - 10) | Not Posted | 2 hours | Participants |
| Other Pre-specified | Neonatal Physiological Condition | Umbilical cord blood gases (pH measurement) | Not Posted | 2 hours | Participants |
| Other Pre-specified | Requirement for Opioids in the First 24 Hours After Surgery | Opioid consumption measured in milligrams. | Not Posted | 24 hours | Participants |
| Other Pre-specified | Anesthesia Side Effects | nausea, vomiting, itching (yes/no) | Not Posted | 2 hours | Participants |
| Other Pre-specified | Vasopressor Requirements During Surgery | measured in milligrams | Not Posted | 2 hours | Participants |
| Other Pre-specified | Bromage Score (0 - 3 Scale) | Motor block assessment 0 - Able to move hip, knee, and ankle
| Not Posted | 3 hours | Participants |
| Other Pre-specified | Sensory Block Assessment | Assessed using sharp sensation at the midclavicular line on the abdomen and thorax Reported at the dermatomal level where sharp sensation is first felt | Not Posted | 3 hours | Participants |
| Other Pre-specified | Anesthesia Adverse Effects | Accidental dural puncture, local anesthesia systemic toxicity, high spinal, post dural puncture headache | Not Posted | 24 hours | Participants |
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | 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) | 0 | 66 | 0 | 66 | 0 | 66 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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