Labor Pain
Conditions
Brief summary
Placement of labor epidurals is a very common daily practice in obstetrical anesthesia. Currently, these epidurals are placed based upon palpation of landmarks to determine midline and the correct spinal level for placement. Palpation of these landmarks can be difficult, however, particularly in morbidly obese patients who have significant amounts of soft tissue overlying them. This study seeks to use ultrasound guidance to examine the spine prior to epidural placement, and see what effects this has compared to palpation alone with respect to procedure time, number of attempts, success rate in the first attempt, failure rate, complication rate, patient anxiety levels, and patient satisfaction levels.
Interventions
DEVICEUltrasound
Using ultrasound guidance to evaluate the spine prior to epidural placement
OTHERPalpation
Using palpation only to evaluate the spine prior to epidural placement
Sponsors
West Penn Allegheny Health System
Thomas J. Vernon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current (pregnant) BMI ≥ 40 * Age ≥ 18 * ASA score of 3 or less * Full term pregnancy (37 weeks gestational age or greater)
Exclusion criteria
* Known scoliosis * Known contraindications to neuraxial blockade * Intrauterine fetal demise or non-viable fetus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Time Required for Epidural Catheter Placement | Assessed immediately during epidural catheter placement | Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Attempts at Epidural Catheter Placement | Assessed immediately during epidural catheter placement | — |
| Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt | Assessed immediately during epidural catheter placement | — |
| Complications | Assessed immediately during epidural catheter placement and within 24 hours after delivery | Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported. |
| Epidural Failure Rate | Assessed within 24 hours after delivery | Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported |
| Epidural Procedure Time | Assessed immediately during epidural catheter placement | Time required to successfully place the epidural catheter |
| Patient Anxiety Level | Assessed immediately following epidural catheter placement | Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable. |
| Palpation or Ultrasound Time | Assessed immediately prior to epidural catheter placement | The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion |
| Overall Anesthesia Experience Satisfaction | Measured within 24 hours of delivery | Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used. |
| Epidural Catheter Placement Satisfaction Level | Assessed immediately following epidural catheter placement | Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ultrasound Group The interventional group that will have their spine evaluated by ultrasound prior to epidural placement
Ultrasound: Using ultrasound guidance to evaluate the spine prior to epidural placement | 7 |
| Palpation Group The control group that will have their epidural placed in the usual fashion based on palpation
Palpation: Using palpation only to evaluate the spine prior to epidural placement | 9 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Ultrasound Group | Palpation Group |
|---|---|---|---|
| Age, Continuous | 27.9 years STANDARD_DEVIATION 5.4 | 25.3 years STANDARD_DEVIATION 4.7 | 29.9 years STANDARD_DEVIATION 5.5 |
| American Society of Anesthesiologists (ASA) physical status ASA1 | 0 Participants | 0 Participants | 0 Participants |
| American Society of Anesthesiologists (ASA) physical status ASA2 | 0 Participants | 0 Participants | 0 Participants |
| American Society of Anesthesiologists (ASA) physical status ASA3 | 16 Participants | 7 Participants | 9 Participants |
| Body mass index | 45.8 kg/m^2 STANDARD_DEVIATION 6.6 | 45.6 kg/m^2 STANDARD_DEVIATION 7.4 | 45.9 kg/m^2 STANDARD_DEVIATION 6.3 |
| Estimated gestational age | 38.7 Weeks STANDARD_DEVIATION 1.1 | 39.6 Weeks STANDARD_DEVIATION 0.8 | 38.1 Weeks STANDARD_DEVIATION 1.1 |
| External landmarks visible No | 16 Participants | 7 Participants | 9 Participants |
| External landmarks visible Yes | 0 Participants | 0 Participants | 0 Participants |
| Gravidity | 2 Number of pregnancies | 1 Number of pregnancies | 2 Number of pregnancies |
| Height | 162.8 cm STANDARD_DEVIATION 5.2 | 163.7 cm STANDARD_DEVIATION 5.3 | 162.1 cm STANDARD_DEVIATION 5.3 |
| Palpable interspace No | 4 Participants | 0 Participants | 4 Participants |
| Palpable interspace Yes | 5 Participants | 0 Participants | 5 Participants |
| Parity | 0 Number of children born | 0 Number of children born | 0 Number of children born |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Female | 16 Participants | 7 Participants | 9 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 121.2 kg STANDARD_DEVIATION 15.8 | 122.0 kg STANDARD_DEVIATION 17.1 | 120.6 kg STANDARD_DEVIATION 15.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 9 |
| other Total, other adverse events | 0 / 7 | 3 / 9 |
| serious Total, serious adverse events | 0 / 7 | 0 / 9 |
Outcome results
Primary
Total Time Required for Epidural Catheter Placement
Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter
Time frame: Assessed immediately during epidural catheter placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Group | Total Time Required for Epidural Catheter Placement | 6.1 Minutes | Standard Deviation 3.5 |
| Palpation Group | Total Time Required for Epidural Catheter Placement | 11.0 Minutes | Standard Deviation 5.3 |
Secondary
Complications
Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.
Time frame: Assessed immediately during epidural catheter placement and within 24 hours after delivery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ultrasound Group | Complications | 0 Complications |
| Palpation Group | Complications | 4 Complications |
Secondary
Epidural Catheter Placement Satisfaction Level
Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied.
Time frame: Assessed immediately following epidural catheter placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Group | Epidural Catheter Placement Satisfaction Level | 9 Units on a scale | Standard Deviation 1.2 |
| Palpation Group | Epidural Catheter Placement Satisfaction Level | 7.3 Units on a scale | Standard Deviation 2.8 |
Secondary
Epidural Failure Rate
Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported
Time frame: Assessed within 24 hours after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasound Group | Epidural Failure Rate | 0 Participants |
| Palpation Group | Epidural Failure Rate | 0 Participants |
Secondary
Epidural Procedure Time
Time required to successfully place the epidural catheter
Time frame: Assessed immediately during epidural catheter placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Group | Epidural Procedure Time | 4.33 Minutes | Standard Deviation 3.5 |
| Palpation Group | Epidural Procedure Time | 10.1 Minutes | Standard Deviation 5.4 |
Secondary
Number of Attempts at Epidural Catheter Placement
Time frame: Assessed immediately during epidural catheter placement
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasound Group | Number of Attempts at Epidural Catheter Placement | 1 Number of attempts |
| Palpation Group | Number of Attempts at Epidural Catheter Placement | 5 Number of attempts |
Secondary
Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt
Time frame: Assessed immediately during epidural catheter placement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasound Group | Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt | 5 Participants |
| Palpation Group | Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt | 2 Participants |
Secondary
Overall Anesthesia Experience Satisfaction
Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used.
Time frame: Measured within 24 hours of delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Group | Overall Anesthesia Experience Satisfaction | 79.1 Units on a scale | Standard Deviation 11.8 |
| Palpation Group | Overall Anesthesia Experience Satisfaction | 74.3 Units on a scale | Standard Deviation 9.4 |
Secondary
Palpation or Ultrasound Time
The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion
Time frame: Assessed immediately prior to epidural catheter placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Group | Palpation or Ultrasound Time | 1.8 Minutes | Standard Deviation 0.6 |
| Palpation Group | Palpation or Ultrasound Time | 0.9 Minutes | Standard Deviation 0.1 |
Secondary
Patient Anxiety Level
Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable.
Time frame: Assessed immediately following epidural catheter placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Group | Patient Anxiety Level | 5.4 Units on a scale | Standard Deviation 1.9 |
| Palpation Group | Patient Anxiety Level | 6.0 Units on a scale | Standard Deviation 2.6 |