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

NCT05017584 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: Pro00109119
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Keywords

Tubal ligation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Numerical Pain Rating Scale (NPRS) during surgery

  End of study, up to 2 years

• Side effects

  End of study, up to 2 years

• Nausea

  End of study, up to 2 years

• Vomiting

  End of study, up to 2 years

• Itching

  End of study, up to 2 years

Study Arms (4)

Hyperbaric bupivacaine 10.5mg

EXPERIMENTAL

Drug: Hyperbaric bupivacaine

Hyperbaric bupivacaine 12mg

EXPERIMENTAL

Drug: Hyperbaric bupivacaine

Hyperbaric bupivacaine 13.5mg

EXPERIMENTAL

Drug: Hyperbaric bupivacaine

Hyperbaric bupivacaine 15mg

EXPERIMENTAL

Drug: Hyperbaric bupivacaine

Interventions

Hyperbaric bupivacaine DRUG

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.

Hyperbaric bupivacaine 10.5mg; Hyperbaric bupivacaine 12mg; Hyperbaric bupivacaine 13.5mg; Hyperbaric bupivacaine 15mg

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cameron Taylor, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 24, 2021
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share