Pregnancy
Conditions
Brief summary
The goal of this study is to evaluate the effect of continuous postpartum epidural saline infusion on the reactivation of labor epidurals for postpartum tubal ligation surgery following vaginal delivery.
Detailed description
The aim of this research is to determine the effect of postpartum epidural saline infusion on the reactivation of labor epidural catheters which are used as the anesthetic technique for PPTL following vaginal delivery. It is proposed that continuous epidural saline infusion will decrease the incidence of catheter obstruction by preventing clot, fibrosis, or tissue plugging and therefore improve reactivation rates. To our knowledge, this is a novel method for attempting to improve epidural reactivation rate and if successful, it would challenge the current practice of only capping epidurals following delivery and later attempting reactivation prior to PPTL. This may, possibly, become a new technique used to improve the rate of epidural reactivation for PPTL. If study results show improved labor epidural reactivation rates, benefits would include decreased patient morbidity and greater patient comfort and satisfaction by avoiding the risks of additional neuraxial procedures as well as general anesthesia. These risks include difficult or failed intubation, aspiration, hypotension, headache, postoperative nausea and vomiting, and sore throat. Improving epidural reactivation rate could also result in greater OR efficiency and decreased costs for the patient and hospital. The investigators also hope to elucidate factors associated with catheter migration or dislodgement and subsequent failure of epidural reactivation. Additionally, we hope to determine what effect obesity and length of time prior epidural reactivation have on epidural reactivation rates.
Interventions
Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
OTHERCapped Epidural
epidural will be capped with no saline infusion.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women * 18 to 45 years of age * Admitted to MUSC in labor or for induction of labor resulting in a vaginal delivery epidural analgesia * Postpartum tubal ligation following delivery * American Society of Anesthesiologists (ASA) Physical Class 1, 2, and 3
Exclusion criteria
* Critically Ill Patients (patients admitted to the ICU) * Cognitively Impaired Persons (patients with a diagnosis of cognitive deficit) * Cesarean delivery * Punctured dura * Patients enrolled in other epidural research studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Epidural Reactivation | one year | The goal of this study is to evaluate the effect of continuous postpartum epidural saline infusion on the reactivation of labor epidurals for postpartum tubal ligation surgery following vaginal delivery. |
Secondary
| Measure | Time frame |
|---|---|
| Count of Participants Whose BMI Affected the Reactivation Rate of Labor Epidurals for Postpartum Tubal Ligation Surgery Following Vaginal Delivery. | one year |
| Count of Participants Who Experienced Epidural Reactivation Failure | one year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Capped Epidural Group 1 (control) will have the epidural catheter capped and left in place.
Capped Epidural: epidural will be capped with no saline infusion. | 22 |
| Normal Saline Infusion Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
Normal Saline Infusion: Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour | 14 |
| Total | 36 |
Baseline characteristics
| Characteristic | Normal Saline Infusion | Capped Epidural | 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 | 14 Participants | 22 Participants | 36 Participants |
| Age, Continuous | 32 years | 32 years | 32 years |
| Region of Enrollment United States | 14 Participants | 22 Participants | 36 Participants |
| Sex: Female, Male Female | 14 Participants | 22 Participants | 36 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 / 22 | 0 / 14 |
| other Total, other adverse events | 0 / 22 | 0 / 14 |
| serious Total, serious adverse events | 0 / 22 | 0 / 14 |
Outcome results
Primary
Number of Participants With Successful Epidural Reactivation
The goal of this study is to evaluate the effect of continuous postpartum epidural saline infusion on the reactivation of labor epidurals for postpartum tubal ligation surgery following vaginal delivery.
Time frame: one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capped Epidural | Number of Participants With Successful Epidural Reactivation | 3 participants |
| Normal Saline Infusion | Number of Participants With Successful Epidural Reactivation | 4 participants |
Secondary
Count of Participants Who Experienced Epidural Reactivation Failure
Time frame: one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Capped Epidural | Count of Participants Who Experienced Epidural Reactivation Failure | 1 Participants |
| Normal Saline Infusion | Count of Participants Who Experienced Epidural Reactivation Failure | 0 Participants |
Secondary
Count of Participants Whose BMI Affected the Reactivation Rate of Labor Epidurals for Postpartum Tubal Ligation Surgery Following Vaginal Delivery.
Time frame: one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Capped Epidural | Count of Participants Whose BMI Affected the Reactivation Rate of Labor Epidurals for Postpartum Tubal Ligation Surgery Following Vaginal Delivery. | 4 Participants |
| Normal Saline Infusion | Count of Participants Whose BMI Affected the Reactivation Rate of Labor Epidurals for Postpartum Tubal Ligation Surgery Following Vaginal Delivery. | 4 Participants |