Pain Relief
Conditions
Keywords
Quality of pain relief with 2 different methods of identifying epidural space
Brief summary
The purpose of this study is to determine whether there is a difference in success outcome of the combined spinal epidural labor analgesia between air versus saline when used to identify the epidural space.
Detailed description
When the epidural needle is inserted initially, it is typically connected to a syringe filled with 2-3 ml or air or saline. This is used to help identify the placement of the epidural needle. Both air and saline are commonly used and it is not clear and debatable which is a better method to identify the correct placement of the needle. Some doctors like using air in the syringe because when a drop of clear fluid returned from the smaller spinal needle, it would be clear to indicate the correct space for first dose of medicine since no pre-existing fluid was used. In group Saline, 3 mL of saline will be used. In group Air, 3 mL of air will be used in the syringe during the procedure. The medicine will be administered in the usual manner the doctor has identified the correct location for administration. The amount of pain during labor will be assessed the patient giving a number from 0 to 10 with 0 being no pain and 10 being the worst pain.
Interventions
PROCEDUREAir
3 mls used for identifying epidural space
PROCEDURESaline
3 mls of saline used to identify epidural space
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Pregnant females weighing less than or equal to 250 lbs * Request for neuraxial labor analgesia
Exclusion criteria
* ASA physical status greater than II
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of Spinal Labor Analgesia From Combined Spinal Epidural | 24 hours | Number of participants that had successful spinal labor analgesia in each group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Failed Epidural Catheters | 24 hours | Number of Participants with Failed Epidural Catheters and that had to be replaced at any time measured from the time of the catheter is placed until the time of delivery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1-AIR Air 3 ml used to identify epidural space
Air: 3 mls used for identifying epidural space | 173 |
| 2-SALINE Saline 3 ml used to identify epidural space
Saline: 3 mls of saline used to identify epidural space | 172 |
| Total | 345 |
Baseline characteristics
| Characteristic | 1-AIR | 2-SALINE | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 173 Participants | 172 Participants | 345 Participants |
| Region of Enrollment United States | 173 participants | 172 participants | 345 participants |
| Sex: Female, Male Female | 173 Participants | 172 Participants | 345 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 / 173 | 0 / 172 |
| other Total, other adverse events | 0 / 173 | 0 / 172 |
| serious Total, serious adverse events | 0 / 173 | 0 / 172 |
Outcome results
Primary
Success of Spinal Labor Analgesia From Combined Spinal Epidural
Number of participants that had successful spinal labor analgesia in each group.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1-AIR | Success of Spinal Labor Analgesia From Combined Spinal Epidural | 163 Participants |
| 2-SALINE | Success of Spinal Labor Analgesia From Combined Spinal Epidural | 161 Participants |
p-value: >0.05Chi-squared
p-value: >0.05Chi-squared
Secondary
Number of Participants With Failed Epidural Catheters
Number of Participants with Failed Epidural Catheters and that had to be replaced at any time measured from the time of the catheter is placed until the time of delivery.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1-AIR | Number of Participants With Failed Epidural Catheters | 5 Participants |
| 2-SALINE | Number of Participants With Failed Epidural Catheters | 9 Participants |