Labor Pain
Conditions
Keywords
labor analgesia, neuraxial technique, combined spinal epidural, dural puncture epidural
Brief summary
The primary purpose of this study is to determine if there are differences in block quality between the CSE and DPE techniques for labor analgesia in parturients in active labor. We hypothesize that when compared to the CSE technique, the DPE technique will significantly improve block quality in this population and require fewer top-ups and catheter replacements.
Detailed description
This will be a prospective, double-blinded, randomized trial. Subject identification and recruitment: Women admitted to the Duke Birthing Center for spontaneous or induced labor will be screened. After usual consultation with the anesthesia team is completed and consent for anesthesia services are obtained, eligible patients will be approached to by a member of the study team. As indicated below, we will plan to enroll up to 120 patients to have 100 patients with complete data (50 for the CSE group and 50 for the DPE group). Assignment of Study Cohorts: Study participants will be randomized by computer-generated sequence to CSE or DPE arms, stratified by parity (nulliparous versus multiparous). After the consented and enrolled participant requests labor epidural, a study member will give the anesthesia provider a sealed envelope with study assignment for either standard CSE or DPE technique. Epidural technique: Once the patient requests labor analgesia, the usual standard of care for epidural placement will be initiated. The patient will receive 500-1000 mL fluid preload. Vitals will be monitored by the labor nurse, including continuous pulse oximetry, non-invasive blood-pressure monitoring, and external tocodynamometry. Anesthesia time-out will be performed by the anesthesia provider with participation from the nurse and the patient. All patients will receive a neuraxial technique in the sitting position at L3/4 or L4/5 using loss of resistance to saline. In both the CSE and DPE groups, a 25-G Whitacre needle will be used to puncture the dura. In the CSE group, 10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space. In both groups, the epidural catheter will be threaded 5 cm into the epidural space. In the DPE group, an initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) over 6 minutes. This would not be administered in the CSE group. Labor analgesia will be maintained by programmed intermittent bolus with 8 mL of the same solution every 45 minutes starting 30 minutes after the initial dose. Patients will have patient-controlled epidural analgesia (PCEA) available with an 10 mL dose per demand, every 10 minutes, for a maximum dose of 50 mL for every hour. Data Collection: After the block is placed, a blinded provider will enter the room to collect data. Data will be collected every 3 minutes for the first 30 minutes or until pain score is 1 or 0 with uterine contractions. Subsequent assessments will be every 2 hours until delivery. Management of breakthrough pain will be standardized.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Ages 18-45, singleton, vertex fetuses at 37-41 weeks' gestation, nulliparous and multiparous women, cervical dilation of 2-7cm, pain score \> 4, and English-speaking ability
Exclusion criteria
* Women with major cardiac disease, chronic pain, chronic opioid use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Presence of Any of the Five Block Quality Components (or More Than One) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Motor Block as Measured by the Modified Bromage Score | 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. |
| Duration of the Second Stage of Labor | 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 |
| Total Labor Epidural Time | From placement of epidural to delivery, up to 32 hours | Time from placement of epidural to delivery will be recorded in anesthetic record |
| Maternal Adverse Events | 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 |
| Number of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses | From placement of epidural to delivery, up to 32 hours | — |
| Mode of Delivery | Through completion of the study, up to 32 hours from epidural placement | Spontaneous and assisted deliveries will be recorded |
| Postpartum: Satisfaction With Analgesia Overall | 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 |
| Total Anesthetic Dose Required | From placement of epidural to delivery, up to 32 hours | Total volume of local anesthetic will be recorded. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 48 |
| 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 | 52 |
| Total | 100 |
Baseline characteristics
| Characteristic | Combined Spinal Epidural | Total | Dural Puncture Epidural |
|---|---|---|---|
| Age, Continuous | 31 years STANDARD_DEVIATION 5 | 32 years STANDARD_DEVIATION 4 | 32 years STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 88 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 21 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) White | 29 Participants | 59 Participants | 30 Participants |
| Region of Enrollment United States | 48 Participants | 100 Participants | 52 Participants |
| Sex: Female, Male Female | 48 Participants | 100 Participants | 52 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 52 |
| other Total, other adverse events | 40 / 48 | 37 / 52 |
| serious Total, serious adverse events | 0 / 48 | 0 / 52 |
Outcome results
Number of Participants With the Presence of Any of the Five Block Quality Components (or More Than One)
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.
Time frame: From placement of epidural to delivery of baby, up to 32 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Spinal Epidural | Number of Participants With the Presence of Any of the Five Block Quality Components (or More Than One) | 16 Participants |
| Dural Puncture Epidural | Number of Participants With the Presence of Any of the Five Block Quality Components (or More Than One) | 13 Participants |
Duration of the Second Stage of Labor
Time from initiation of pushing to delivery of baby will be recorded
Time frame: From start of second stage of labor to delivery, up to 6 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combined Spinal Epidural | Duration of the Second Stage of Labor | 23 minutes |
| Dural Puncture Epidural | Duration of the Second Stage of Labor | 47 minutes |
Maternal Adverse Events
This will include instances such as: hypotension defined as 20% drop in blood pressure from admission blood pressure, fetal bradycardia, PDPH
Time frame: From placement of epidural to delivery, up to 32 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Spinal Epidural | Maternal Adverse Events | 40 Participants |
| Dural Puncture Epidural | Maternal Adverse Events | 37 Participants |
Mode of Delivery
Spontaneous and assisted deliveries will be recorded
Time frame: Through completion of the study, up to 32 hours from epidural placement
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combined Spinal Epidural | Mode of Delivery | Spontaneous Vaginal Delivery | 32 Participants |
| Combined Spinal Epidural | Mode of Delivery | Forceps Assisted Delivery | 2 Participants |
| Combined Spinal Epidural | Mode of Delivery | Vacuum Assisted Delivery | 1 Participants |
| Combined Spinal Epidural | Mode of Delivery | Cesarean Delivery | 13 Participants |
| Dural Puncture Epidural | Mode of Delivery | Cesarean Delivery | 18 Participants |
| Dural Puncture Epidural | Mode of Delivery | Spontaneous Vaginal Delivery | 33 Participants |
| Dural Puncture Epidural | Mode of Delivery | Vacuum Assisted Delivery | 0 Participants |
| Dural Puncture Epidural | Mode of Delivery | Forceps Assisted Delivery | 1 Participants |
Number of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses
Time frame: From placement of epidural to delivery, up to 32 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Spinal Epidural | Number of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses | 40 Participants |
| Dural Puncture Epidural | Number of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses | 41 Participants |
Number of Participants With Motor Block as Measured by the Modified Bromage Score
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.
Time frame: From placement of epidural to delivery, up to 32 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Spinal Epidural | Number of Participants With Motor Block as Measured by the Modified Bromage Score | 13 Participants |
| Dural Puncture Epidural | Number of Participants With Motor Block as Measured by the Modified Bromage Score | 10 Participants |
Postpartum: Satisfaction With Analgesia Overall
Patient satisfaction scores will be recorded from scale of 0 to 10, with 10 being the highest level of satisfaction
Time frame: From placement of epidural to delivery, up to 32 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combined Spinal Epidural | Postpartum: Satisfaction With Analgesia Overall | 10 score on a scale (0-10) |
| Dural Puncture Epidural | Postpartum: Satisfaction With Analgesia Overall | 10 score on a scale (0-10) |
Total Anesthetic Dose Required
Total volume of local anesthetic will be recorded.
Time frame: From placement of epidural to delivery, up to 32 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combined Spinal Epidural | Total Anesthetic Dose Required | 108 mL |
| Dural Puncture Epidural | Total Anesthetic Dose Required | 108 mL |
Total Labor Epidural Time
Time from placement of epidural to delivery will be recorded in anesthetic record
Time frame: From placement of epidural to delivery, up to 32 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combined Spinal Epidural | Total Labor Epidural Time | 443 Minutes |
| Dural Puncture Epidural | Total Labor Epidural Time | 534 Minutes |