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

Duke University

Status and phase: Withdrawn; Phase 4

Conditions: Pain

Treatments: Drug: Hyperbaric bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05017584

Pro00109119

Details and patient eligibility

About

The purpose of this study is to determine the dose of bupivacaine that provides effective pain management in 90% (ED90) of patients undergoing bilateral tubal ligation. This will guide anesthesiologists on the most effective dose to minimize intraoperative pain during this procedure. The goal is to make women as comfortable as possible when they undergo this procedure while also minimizing the amount of time they are required to remain in the hospital afterwards for monitoring.

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ≥ 18 years of age
• American Society of Anesthesiology class II or III
• bilateral tubal ligation

Exclusion criteria

• patient refusal
• BMI ≥ 50 kg/m2
• American Society of Anesthesiology class IV or above
• contraindication to neuraxial anesthesia
• allergy to bupivacaine

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups

Hyperbaric bupivacaine 10.5mg

Experimental group

Treatment:

Drug: Hyperbaric bupivacaine

Hyperbaric bupivacaine 12mg

Experimental group

Treatment:

Drug: Hyperbaric bupivacaine

Hyperbaric bupivacaine 13.5mg

Experimental group

Treatment:

Drug: Hyperbaric bupivacaine

Hyperbaric bupivacaine 15mg

Experimental group

Treatment:

Drug: Hyperbaric bupivacaine