Determining the ED90 for Intrathecal 0.75% Hyperbaric Bupivacaine for Bilateral Tubal Ligation
Overview
- Phase
- Phase 4
- Intervention
- Hyperbaric bupivacaine
- Conditions
- Pain
- Sponsor
- Duke University
- Primary Endpoint
- 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.
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Hyperbaric bupivacaine 10.5mg
Intervention: Hyperbaric bupivacaine
Hyperbaric bupivacaine 12mg
Intervention: Hyperbaric bupivacaine
Hyperbaric bupivacaine 13.5mg
Intervention: Hyperbaric bupivacaine
Hyperbaric bupivacaine 15mg
Intervention: Hyperbaric bupivacaine
Outcomes
Primary Outcomes
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.
Time Frame: End of study, up to 2 years
Secondary Outcomes
- 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)
- Vasopressor use(End of study, up to 2 years)
- Patient satisfaction(End of study, up to 2 years)