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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Hyperbaric bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperbaric bupivacaine 10.5mg<br> | Drug: Hyperbaric bupivacaine<br>* 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.<br>|
| Experimental: Hyperbaric bupivacaine 12mg<br> | Drug: Hyperbaric bupivacaine<br>* 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.<br>|
| Experimental: Hyperbaric bupivacaine 13.5mg<br> | Drug: Hyperbaric bupivacaine<br>* 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.<br>|
| Experimental: Hyperbaric bupivacaine 15mg<br> | Drug: Hyperbaric bupivacaine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Side effects | Incidence of side effects intra-operatively | End of study, up to 2 years | 
| Nausea | Presence of absence of nausea | End of study, up to 2 years | 
| Vomiting | Presence of absence of vomiting | End of study, up to 2 years | 
| Itching | Presence of absence of itching | End of study, up to 2 years | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tubal ligation