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

Pain Clinical Trial

Official title:

Determining the ED90 for Intrathecal 0.75% Hyperbaric Bupivacaine for Bilateral Tubal Ligation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05017584
• Other study ID #: Pro00109119
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Numerical Pain Rating Scale (NPRS) during surgery	Pain rating 0-10 as outlined by the NPRS by patient during procedure, in the post-anesthesia care unit, and overall at discharge	End of study, up to 2 years
Secondary	Side effects	Incidence of side effects intra-operatively	End of study, up to 2 years
Secondary	Nausea	Presence of absence of nausea	End of study, up to 2 years
Secondary	Vomiting	Presence of absence of vomiting	End of study, up to 2 years
Secondary	Itching	Presence of absence of itching	End of study, up to 2 years
Secondary	Vasopressor use	Number of participants requiring the of vasopressors (phenylephrine and ephedrine). Indicated for blood pressure drops greater than 15% below baseline or < 100mm Hg systolic.	End of study, up to 2 years
Secondary	Patient satisfaction	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	End of study, up to 2 years