Tubal LigationNCT00898443
Continuous Labor Epidural Catheter for Tubal Ligation Study
A study testing Epidural anesthetic and Spinal anesthetic in people with Tubal Ligation and Bilateral Tubal Ligation, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Tubal Ligation, Bilateral Tubal Ligation
- What is being tested?
- Epidural anesthetic and Spinal anesthetic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
Official title: Success Rate, Efficiency, and Predictors of Reactivation of a Continuous Labor Epidural Catheter for Postpartum Tubal Ligation
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.
- Conditions
- Tubal Ligation, Bilateral Tubal Ligation
- Being tested
- Epidural anesthetic, Spinal anesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural anestheticOther
Use of the existing continuous labor epidural for surgical anesthetic for postpartum tubal ligation
Spinal anestheticOther
This group was assigned to receive spinal anesthetic for postpartum tubal ligation.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anesthetic Group | Other | This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study. Receives: Other: Spinal anesthetic |
| Epidural Anesthetic Group | Experimental | This is the experimental group for this study. Receives: Other: Epidural anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: at the time of surgery
Secondary outcomes (1)
Impact of Anesthesia Type on OR (Operating Room) Efficiency
The time minutes)from initiation of anesthesia to surgery start.
Measured: minutes until surgery start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startOct 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tubal LigationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marsha Wakefield, MD, University of Alabama at Birmingham
- Investigators
- Marsha L. Wakefield, MD, Principal investigator, UAB Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898443
- Sponsor's protocol ID
- F080829007
- Status last verified
- Jun 2012
- First submitted
- 8 May 2009
- Last updated
- 7 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success Rate, Efficiency, and Predictors of Reactivation of a Continuous Labor Epidural Catheter for Postpartum Tubal Ligation
- ClinicalTrials.gov ID
- NCT00898443
- Acronym / sponsor ID
- F080829007
- Conditions
- Tubal Ligation, Bilateral Tubal Ligation
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Posted 7 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthetic Group | Other | Other: Spinal anestheticThis group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study. |
| Epidural Anesthetic Group | Experimental | Other: Epidural anestheticThis is the experimental group for this study. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural anestheticUse of the existing continuous labor epidural for surgical anesthetic for postpartum tubal ligation | Other | Epidural Anesthetic Group |
| Spinal anestheticThis group was assigned to receive spinal anesthetic for postpartum tubal ligation. | Other | Spinal Anesthetic Group |
Primary outcome
Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation
Time frame: 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.)
1 secondary outcome
Impact of Anesthesia Type on OR (Operating Room) Efficiency
Time frame: minutes until surgery start
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Tubal Ligation
Recruiting
Using the CompuFlo® CathCheck™ System to Check Epidural Catheter Function Before Tubal Ligation: A Pilot Study
Anesthesia, Epidural
Enrolling by invitationObservational study
Stop Ovarian Cancer Young; Effect of the Opportunistic Salpingectomy on Age of Menopause
Salpingectomy, Tubal Ligation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marsha L. Wakefield, MD principal investigator
UAB Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural anesthetic and Spinal anesthetic in people with Tubal Ligation and Bilateral Tubal Ligation, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation (time frame: at the time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2012.