ED90 of 0.75% Bupivacaine for Bilateral Tubal Ligation (BTL)
Determining the ED90 for Intrathecal 0.75% Hyperbaric Bupivacaine for Bilateral Tubal Ligation
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Phase
- Phase 4
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
|
Experimental: 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. |
|
Experimental: 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. |
|
Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
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.
Zeitfenster: End of study, up to 2 years
|
End of study, up to 2 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Numerical Pain Rating Scale (NPRS) during surgery
Zeitfenster: 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
Zeitfenster: End of study, up to 2 years
|
Incidence of side effects intra-operatively
|
End of study, up to 2 years
|
|
Nausea
Zeitfenster: End of study, up to 2 years
|
Presence of absence of nausea
|
End of study, up to 2 years
|
|
Vomiting
Zeitfenster: End of study, up to 2 years
|
Presence of absence of vomiting
|
End of study, up to 2 years
|
|
Itching
Zeitfenster: End of study, up to 2 years
|
Presence of absence of itching
|
End of study, up to 2 years
|
|
Vasopressor use
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Cameron Taylor, MD, Duke University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Voraussichtlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Pro00109119
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