ED50 and ED95 of Isobaric Bupivacaine for Post-Partum Bilateral Tubal Ligation
Completed · Not applicable
Conditions studied: Anesthesia, Local
In brief
Spinal anesthesia is one of the preferred anesthetic techniques for post-partum bilateral tubal ligation (PBTL). Bupivacaine is the most commonly used local anesthetic for neuraxial anesthesia for post-partum tubal ligation. Typically, hyperbaric bupivacaine would be injected into the spinal (intrathecal) space via a spinal needle; however, ongoing medication shortages have resulted in limited availability on a local and national level. One proposed alternative is isobaric bupivacaine; however, studies investigating its use for post-partum bilateral tubal ligation are limited. The purpose of this prospective study is to determine the minimal effective dose (ED50 and ED95) of isobaric bupivacaine for adequate anesthesia during post-partum tubal ligation after vaginal delivery.
Key facts
- Study ID
- NCT03779568
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 33
- Starts
- 2019-02-25
- Expected to finish
- 2020-04-09
- Last updated by the study team
- 2020-05-19
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 and older
- Patients undergoing elective post-partum bilateral tubal ligation after vaginal delivery
- Patients receiving spinal epidural anesthesia with combination of bupivacaine and fentanyl
You may not qualify if…
- American Society of Anesthesiologists physical status score >3,
- Contraindications to neuraxial analgesia
- Patients in whom a combined spinal epidural cannot be performed
- Body mass index >40 kg/m2
- Allergy or hypersensitivity to local anesthetics and fentanyl
- Severe liver, kidney or respiratory disease.
- Inability to understand the study protocol
- Refusal to provide written consent
Where it is running
- Parkland Hospital — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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