Tubal Ligation, Bilateral Tubal Ligation
Conditions
Brief summary
This study is to study the success rate of using the epidural catheter that was placed during the labor for the surgical anesthesia to perform a postpartum tubal ligation.
Interventions
OTHEREpidural anesthetic
Use of the existing continuous labor epidural for surgical anesthetic for postpartum tubal ligation
OTHERSpinal anesthetic
This group was assigned to receive spinal anesthetic for postpartum tubal ligation.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) 1-3 postpartum women desiring Postpartum Bilateral Tubal Ligation (PPBTL) for infertility * Functional epidural catheter placed for labor and delivery analgesia * The epidural is still taped within 1cm of the original depth when it was functional for labor analgesia * 1-45 years of age
Exclusion criteria
* ASA 4 status * History of dural puncture (wet tap) during initial epidural catheter insertion * History of marginal or inadequate epidural analgesia for labor * Cesarean section for delivery * Examination demonstrates that the indwelling catheter has migrated more than 1 cm from the original depth when secured * The end of indwelling epidural catheter appears to have not been capped appropriately or the cap was not maintained intact * Prolonged sensory or motor block, bladder or anal sphincter dysfunction, nerve damage, inability to ambulate, post-dural puncture headache (PDHD), or seizures, during or after delivery and following cessation of the epidural catheter dosing * Pseudocholinesterase deficiency * Allergy to Nesacaine® (chloroprocaine) or lidocaine * General anesthesia provided for delivery * History of substance abuse disorder * History of major psychiatric disorder * Non-English reading/speaking participants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation | at the time of surgery | Rate of reactivation of the epidural catheter for postpartum tubal ligation in the group that was randomized to the epidural anesthetic group. (Need for additional supplemental analgesics and sedatives or the need to convert to general anesthesia.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Anesthesia Type on OR (Operating Room) Efficiency | minutes until surgery start | The time minutes)from initiation of anesthesia to surgery start. |
Countries
United States
Participant flow
Recruitment details
Women in labor, admitted to UAB Labor & Delivery, who requested postpartum tubal ligation after delivery.
Participants by arm
| Arm | Count |
|---|---|
| Spinal Anesthetic Group This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study. | 9 |
| Epidural Anesthetic Group This is the experimental group for this study. | 8 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Spinal Anesthetic Group | Epidural Anesthetic Group | 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 | 9 Participants | 8 Participants | 17 Participants |
| Region of Enrollment United States | 9 participants | 8 participants | 17 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 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 | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 8 |
| serious Total, serious adverse events | 0 / 9 | 0 / 8 |
Outcome results
Primary
Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation
Rate of reactivation of the epidural catheter for postpartum tubal ligation in the group that was randomized to the epidural anesthetic group. (Need for additional supplemental analgesics and sedatives or the need to convert to general anesthesia.)
Time frame: at the time of surgery
Population: Only the patients who were recruited, randomized and had all their data completed at the time of their procedure were included in the analysis. Insufficient numbers were recruited to complete the study as designed.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Spinal Anesthetic Group | Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation | 0 participants | 0 |
| Epidural Anesthetic Group | Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation | 7 participants | 0 |
Secondary
Impact of Anesthesia Type on OR (Operating Room) Efficiency
The time minutes)from initiation of anesthesia to surgery start.
Time frame: minutes until surgery start
Population: Only the patients who were recruited, randomized and had all their data completed at the time of their procedure were included in the analysis. Insufficient numbers were recruited to complete the study as designed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Spinal Anesthetic Group | Impact of Anesthesia Type on OR (Operating Room) Efficiency | 14 minutes |
| Epidural Anesthetic Group | Impact of Anesthesia Type on OR (Operating Room) Efficiency | 29 minutes |