ED90 of 0.75% Bupivacaine for Bilateral Tubal Ligation (BTL)

PHASE4WithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 31, 2023

Primary Completion Date

January 1, 2024

Study Completion Date

January 1, 2024

Conditions
Pain
Interventions
DRUG

Hyperbaric bupivacaine

"The dose for the first subject (A#X) will be 12 mg 0.75% hyperbaric bupivacaine. Two possible outcomes will be recorded: satisfactory or unsatisfactory anesthesia which is determined by occurrence of intraoperative pain and the need for intraoperative analgesia supplementation. Satisfactory analgesia will be defined as a sensory block to the T8 dermatome and the patient shall require no further supplementation for discomfort during her procedure. Unsatisfactory analgesia will be defined as a block not achieving a T8 dermatomal level or when a patient requests additional medication for discomfort at any time during her procedure.~The dose for the next (A#X+1) will be adjusted based on the outcome from previous subjects respectively using up-down sequential allocation method with a biased-coin design. This process will continue in similar fashion with dose adjustments for next subjects to be based on outcome from subjects immediately prior."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duke University

OTHER