Analgesia
Conditions
Keywords
neuraxial analgesia, spinal block, epidural block
Brief summary
We hypothesize that the Rivanna Accuro or similar U/S device would reduce time to success of identifying epidural and/or intrathecal spaces as compared to conventional palpation method.
Detailed description
Administration of (neuraxial blocks) spinal and epidural blocks is commonly achieved by first palpating the landmarks for midline with spinous process and iliac crest for L3-4-5 intervertebral spaces. With an epidural block, a loss of resistance in a pressurized syringe is used to incrementally advance the epidural needle until identification of epidural space with loss of resistance in the pressurized syringe. With a spinal block, the spinal needle is advanced incrementally until a noted feel of dural puncture together with return of spinal fluid via the spinal needle. The palpation technique and somewhat blind technique to identify the spinal and epidural spaces become more difficult and less reliable particularly with the increasing prevalence of the morbid and super-morbid obese patients. Ultrasound devices have become common and successful with non-neuraxial blocks and venous accesses, both involving mostly non-bony, soft tissues. Application of conventional ultrasound for neuraxial blocks has been limited by its bulkiness, limited imaging for bony structures and lack of automated artificial intelligent algorithm for pattern recognition. Recent technological advancement has addressed the aforementioned limitations. Rivanna Accuro is one such device that has gained FDA approval and may have helped in addressing some of these issues. It is a handheld (pocket size) U/S device with real time pattern recognition for bony structures such as the spine while providing 3-D overlay for recognition of the midline spinous process and epidural spaces and distance. The investigators hypothesize that the Rivanna Accuro or similar U/S device would reduce time to success of identifying epidural and/or intrathecal spaces as compared to conventional palpation method. We will compare placement of neuraxial block between palpation method versus ultrasound method. We will compare placement of spinal block for cesarean delivery with palpation versus with ultrasound method, and then comparing placement of neuraxial analgeisa block (combined spinal epidural analgesia) for labor analgesia with palpation versus ultrasound method.
Interventions
DEVICERivanna Accuro US Device
When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Rivanna Accuro U/S device. For subjects in group C-R or L-R, the needle insertion site will be the site identified by the Rivanna Accuro U/S device. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.
OTHERPalpation
When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method using conventional landmarks (spinous process and iliac crest). For subjects in group C-P or L-P, the needle insertion site will be the site identified by the Palpation method. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.
PROCEDURENeuraxial Analgesia
Labor analgesia will be provided utilizing the standard medications to provide labor analgesia
PROCEDURESpinal Block
Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
There are 4 arms for this study--two are active comparators and two are experimental. The first arm is palpation with spinal block. The second arm is palpation with neuraxial block. The third arm is ultrasound with spinal block. The fourth arm is ultrasound with neuraxial block. Randomization is done twice - first for randomization of spinal block subjects between using palpation versus ultrasound method; and again randomization for neuraxial block (combined spinal epidural) subjects between using palpation versus ultrasound method. There will be a total of 120 planned evaluable subjects. This consists of planned evaluable randomized 60 subjects receiving spinal block for cesarean delivery (30 for palpation and 30 for ultrasound); and planned evaluable randomized 60 subjects receiving neuraxial (combined spinal epidural) block for labor analgesia.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* BMI \>30 * Female requesting analgesia for delivery, be it via vaginal or cesarean delivery
Exclusion criteria
* Allergy to ultrasound gel * Contraindication to receiving neuraxial analgesia * Under the age of 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Success of Neuraxial Block Placement | 60-225 seconds | Time it takes to successfully identify the epidural space (defined by loss of resistance) for the groups of subjects receiving labor neuraxial analgesia; and spinal fluid flow into the hub of spinal needle for the groups of subjects receiving cesarean spinal anesthetic - length of time (in minutes) it takes to get block placed, between palpation and ultrasound groups among patients with labor neuraxial analgesia patients and cesarean spinal anesthetic, respectively and spinal fluid flow with spinal needle - length of time (in seconds) it takes to get block placed, between the 2 groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Needle Passes Per Placement | 1 hour | Number of needle Passes before successful placement |
| Needle Passing Success at First Attempt | 1 hour | Number of times of success (Number of patients) with first (single) attempt needle pass success |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Palpation With Spinal Block (Group C-P) insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest) for placement of spinal block for cesarean delivery
Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. For subjects in group C-P or L-P, the needle insertion site will be the site identified by the Palpation method. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.
Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care | 30 |
| Palpation With Neuraxial Block (Group L-P) the needle insertion site for the neuraxial block will be identified with palpation for labor analgesia
Palpation description:: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method. For subjects in group C-P or L-P, the needle insertion site will be the site identified by the Palpation method. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest). Those in group P, the neuraxial block will be performed as in the usual method using the needle insertion site identified with palpation. After placement of neuraxial labor analgesia the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.
Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia | 30 |
| Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R) insertion will be identified with Rivanna Accuro U/S device for placement of spinal block for cesarean delivery
Rivanna Accuro US Device: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Rivanna Accuro U/S device. For subjects in group C-R or L-R, the needle insertion site will be the site identified by the Rivanna Accuro U/S device. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.
Spinal Block: Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care | 30 |
| Rivanna Ultrasound Device With Neuraxial Block (Group L-R) insertion will be identified with Rivanna Accuro U/S device for placement of neuraxial block (combined spinal epidural) for labor analgesia
Rivanna Accuro US Device: When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Rivanna Accuro U/S device. For subjects in group C-R or L-R, the needle insertion site will be the site identified by the Rivanna Accuro U/S device. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.
Neuraxial Analgesia: Labor analgesia will be provided utilizing the standard medications to provide labor analgesia | 30 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 2 | 1 | 4 |
Baseline characteristics
| Characteristic | Total | Palpation With Spinal Block (Group C-P) | Palpation With Neuraxial Block (Group L-P) | Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R) | Rivanna Ultrasound Device With Neuraxial Block (Group L-R) |
|---|---|---|---|---|---|
| Age, Continuous | 29.53 years STANDARD_DEVIATION 5.6 | 32.4 years STANDARD_DEVIATION 5.8 | 27.3 years STANDARD_DEVIATION 5.3 | 29.8 years STANDARD_DEVIATION 4.8 | 28.6 years STANDARD_DEVIATION 6.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 8 Participants | 7 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 92 Participants | 20 Participants | 22 Participants | 24 Participants | 26 Participants |
| Region of Enrollment United States | 120 participants | 30 participants | 30 participants | 30 participants | 30 participants |
| Sex/Gender, Customized Female Subjects | 120 Participants | 30 Participants | 30 Participants | 30 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Time to Success of Neuraxial Block Placement
Time it takes to successfully identify the epidural space (defined by loss of resistance) for the groups of subjects receiving labor neuraxial analgesia; and spinal fluid flow into the hub of spinal needle for the groups of subjects receiving cesarean spinal anesthetic - length of time (in minutes) it takes to get block placed, between palpation and ultrasound groups among patients with labor neuraxial analgesia patients and cesarean spinal anesthetic, respectively and spinal fluid flow with spinal needle - length of time (in seconds) it takes to get block placed, between the 2 groups.
Time frame: 60-225 seconds
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palpation With Spinal Block (Group C-P) | Time to Success of Neuraxial Block Placement | 122 seconds |
| Palpation With Neuraxial Block (Group L-P) | Time to Success of Neuraxial Block Placement | 111 seconds |
| Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R) | Time to Success of Neuraxial Block Placement | 50 seconds |
| Rivanna Ultrasound Device With Neuraxial Block (Group L-R) | Time to Success of Neuraxial Block Placement | 78.5 seconds |
Secondary
Needle Passing Success at First Attempt
Number of times of success (Number of patients) with first (single) attempt needle pass success
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palpation With Spinal Block (Group C-P) | Needle Passing Success at First Attempt | 10 participants |
| Palpation With Neuraxial Block (Group L-P) | Needle Passing Success at First Attempt | 18 participants |
| Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R) | Needle Passing Success at First Attempt | 18 participants |
| Rivanna Ultrasound Device With Neuraxial Block (Group L-R) | Needle Passing Success at First Attempt | 24 participants |
Secondary
Total Number of Needle Passes Per Placement
Number of needle Passes before successful placement
Time frame: 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palpation With Spinal Block (Group C-P) | Total Number of Needle Passes Per Placement | 2 number of needle passes needed to succes |
| Palpation With Neuraxial Block (Group L-P) | Total Number of Needle Passes Per Placement | 1 number of needle passes needed to succes |
| Rivanna Accuro Ultrasound Device With Spinal Block (Group C-R) | Total Number of Needle Passes Per Placement | 1 number of needle passes needed to succes |
| Rivanna Ultrasound Device With Neuraxial Block (Group L-R) | Total Number of Needle Passes Per Placement | 1 number of needle passes needed to succes |