Pain
Conditions
Keywords
Tubal ligation
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.
Interventions
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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Itching | End of study, up to 2 years | Presence of absence of itching |
Outcome results
None listed