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

Phase 4

Withdrawn

• Conditions: Pain
• Interventions: Drug: Hyperbaric bupivacaine

• Registration Number: NCT05017584
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-24
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-27
• Study Start: 2023-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperbaric bupivacaine 10.5mg	Hyperbaric bupivacaine	-
Hyperbaric bupivacaine 12mg	Hyperbaric bupivacaine	-
Hyperbaric bupivacaine 13.5mg	Hyperbaric bupivacaine	-
Hyperbaric bupivacaine 15mg	Hyperbaric bupivacaine	-

Primary Outcome Measures

Name	Time	Method
Dose (in mg) of intrathecal 0.75% hyperbaric bupivacaine that provides effective analgesia in 90% of patients undergoing bilateral tubal ligation as measured by patient reported effectiveness.	End of study, up to 2 years

Secondary Outcome Measures

Name	Time	Method
Numerical Pain Rating Scale (NPRS) during surgery	End of study, up to 2 years	Pain rating 0-10 as outlined by the NPRS by patient during procedure, in the post-anesthesia care unit, and overall at discharge
Side effects	End of study, up to 2 years	Incidence of side effects intra-operatively
Nausea	End of study, up to 2 years	Presence of absence of nausea
Vomiting	End of study, up to 2 years	Presence of absence of vomiting
Itching	End of study, up to 2 years	Presence of absence of itching
Vasopressor use	End of study, up to 2 years	Number of participants requiring the of vasopressors (phenylephrine and ephedrine). Indicated for blood pressure drops greater than 15% below baseline or \< 100mm Hg systolic.
Patient satisfaction	End of study, up to 2 years	Overall patient satisfaction at discharge as measured by patient report. This will be obtained using a scale of 1-5 where 1 = very unsatisfied, 2 = unsatisfied, 3 = neither unsatisfied or satisfied, 4 = satisfied, and 5 = very satisfied