ED90 of 0.75% Bupivacaine for Bilateral Tubal Ligation (BTL)
Determining the ED90 for Intrathecal 0.75% Hyperbaric Bupivacaine for Bilateral Tubal Ligation
Přehled studie
Typ studie
Fáze
- Fáze 4
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Hyperbaric bupivacaine 10.5mg
|
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. |
|
Experimentální: Hyperbaric bupivacaine 12mg
|
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. |
|
Experimentální: Hyperbaric bupivacaine 13.5mg
|
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. |
|
Experimentální: Hyperbaric bupivacaine 15mg
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
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.
Časové okno: End of study, up to 2 years
|
End of study, up to 2 years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Numerical Pain Rating Scale (NPRS) during surgery
Časové okno: 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
|
End of study, up to 2 years
|
|
Side effects
Časové okno: End of study, up to 2 years
|
Incidence of side effects intra-operatively
|
End of study, up to 2 years
|
|
Nausea
Časové okno: End of study, up to 2 years
|
Presence of absence of nausea
|
End of study, up to 2 years
|
|
Vomiting
Časové okno: End of study, up to 2 years
|
Presence of absence of vomiting
|
End of study, up to 2 years
|
|
Itching
Časové okno: End of study, up to 2 years
|
Presence of absence of itching
|
End of study, up to 2 years
|
|
Vasopressor use
Časové okno: 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.
|
End of study, up to 2 years
|
|
Patient satisfaction
Časové okno: 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
|
End of study, up to 2 years
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Cameron Taylor, MD, Duke University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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