ED50 and ED95 of Isobaric Bupivacaine for Post-Partum Bilateral Tubal Ligation

NCT03779568 | Completed

• 1 other identifier: STU 082018-026
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Success or failure of the intrathecal block

  The score of 1 or 2 within 10-15 minutes of injection will be evaluated as successful motor block.

  Perioperative

Study Arms (1)

Dose adjustment of bupivacaine

EXPERIMENTAL

Patient will receive isobaric bupivacaine based on previous patient experience.

Other: Dose adjustment of bupivacaine

Interventions

Dose adjustment of bupivacaine OTHER

Spinal bupivacaine dose will be adjusted according to previous patient experience.

Also known as: Spinal bupivacaine dose adjustment

Dose adjustment of bupivacaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Hospital

Dallas, Texas, 75235, United States

Location

Study Officials

• Seema Dave, MPH

  University of Texas Southwestern Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: February 25, 2019
• Primary Completion: June 17, 2019
• Study Completion: April 9, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)