ED90 of 0.75% Bupivacaine for Bilateral Tubal Ligation (BTL)
Determining the ED90 for Intrathecal 0.75% Hyperbaric Bupivacaine for Bilateral Tubal Ligation
調査の概要
研究の種類
段階
- フェーズ 4
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
実験的：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. |
|
実験的：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. |
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
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.
時間枠：End of study, up to 2 years
|
End of study, up to 2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Numerical Pain Rating Scale (NPRS) during surgery
時間枠：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
時間枠：End of study, up to 2 years
|
Incidence of side effects intra-operatively
|
End of study, up to 2 years
|
|
Nausea
時間枠：End of study, up to 2 years
|
Presence of absence of nausea
|
End of study, up to 2 years
|
|
Vomiting
時間枠：End of study, up to 2 years
|
Presence of absence of vomiting
|
End of study, up to 2 years
|
|
Itching
時間枠：End of study, up to 2 years
|
Presence of absence of itching
|
End of study, up to 2 years
|
|
Vasopressor use
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Cameron Taylor, MD、Duke University
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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