UMIN試験ID | UMIN000013695 |
---|---|
受付番号 | R000015987 |
科学的試験名 | 日本のおけるくも膜下モルヒネによる帝王切開術後掻痒に対する鍼治療の有効性に関する無作為ランダム化並行群間比較試験 |
一般公開日(本登録希望日) | 2014/04/12 |
最終更新日 | 2021/01/16 21:50:20 |
日本語
日本のおけるくも膜下モルヒネによる帝王切開術後掻痒に対する鍼治療の有効性に関する無作為ランダム化並行群間比較試験
英語
JAPAN, Randomized, Parallel-Group Comparison Study on Clinical Efficacy of Acupuncture for Post-Cesarean Pruritus due to Intrathecal Morphine
日本語
JEAPCP-ITM study
英語
JEAPCP-ITM study
日本語
日本のおけるくも膜下モルヒネによる帝王切開術後掻痒に対する鍼治療の有効性に関する無作為ランダム化並行群間比較試験
英語
JAPAN, Randomized, Parallel-Group Comparison Study on Clinical Efficacy of Acupuncture for Post-Cesarean Pruritus due to Intrathecal Morphine
日本語
JEAPCP-ITM study
英語
JEAPCP-ITM study
日本/Japan |
日本語
帝王切開の術後
英語
postoperative state of cesarean section
産婦人科学/Obstetrics and Gynecology | 麻酔科学/Anesthesiology |
悪性腫瘍以外/Others
いいえ/NO
日本語
帝王切開術鎮痛では,鎮痛効果に優れ,早期離床を可能にすることから,オピオイドのくも膜下投与が推奨されており,作用時間が長いことから水溶性オピオイドであるモルヒネが使用されている.しかし,その副作用として掻痒があり,時として分娩後育児を困難とする.一方,一般手術後の掻痒に関して鍼治療が有効であることが報告されている.
本研究の目的は,くも膜下モルヒネによる帝王切開術後掻痒が,鍼治療により減少するかどうかを明らかにすることである.
英語
Intrathecal opioid for post-cesarean analgesia has been recommended because of its efficacy and possibility to early postoperative ambulation. Morphine. water-soluble strong opioid, provides extended analgesia after intrathecal administration and is used in many clinical situations. However, intrathecal morphine causes pruritus and this complication make sometimes the post-cesarean patients mothering difficult. On the other hand, the efficacy of acupuncture fore reducing postoperative pruritus after general surgery has been reported.
The purpose of this study is elucidate the efficacy of acupuncture for reducing post-cesarean pruritus administrated morphine intrathecally.
安全性・有効性/Safety,Efficacy
日本語
英語
検証的/Confirmatory
説明的/Explanatory
第Ⅱ相/Phase II
日本語
術後掻痒の合併
英語
Incidence of postoperative pruritus
日本語
術後悪心・嘔吐の合併
術後鎮痛(NRS)
薬物治療の頻度
英語
Incidence of postoperative nausea and vomiting
Numeric Rating Scale for postoperative pain
Incidence of drug treatment
介入/Interventional
並行群間比較/Parallel
ランダム化/Randomized
個別/Individual
二重盲検/Double blind -all involved are blinded
プラセボ・シャム対照/Placebo
はい/YES
いいえ/NO
施設を考慮していない/Institution is not considered as adjustment factor.
いいえ/NO
封筒法/Numbered container method
2
治療・ケア/Treatment
手技/Maneuver |
日本語
円皮鍼
英語
Thumb Tack Needles
日本語
シャム
英語
Sham
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
16 | 歳/years-old | 以上/<= |
50 | 歳/years-old | 未満/> |
女/Female
日本語
1)帝王切開が予定されている妊婦
2)脊髄くも膜下麻酔を施行し,くも膜下モルヒネを投与されたもの
3)言語コミュニケーションに問題がなく,本研究の参加に対して十分な説明を受けた後,本人の自由意志により文書による同意が得られているもの
英語
1) Parturients who will receive cesarean section
2) Performed spinal anesthesia and administered morphine intrathecally
3) Parturients must have oral communication ability; can provide written informed consent signed by herself under her free will after receiving full explanation of the study.
日本語
本研究に同意が得られなかったもの
英語
Parturients who do not consent to the nature of the study
30
日本語
名 | 祐典 |
ミドルネーム | |
姓 | 松田 |
英語
名 | Yusue |
ミドルネーム | |
姓 | Mazda |
日本語
埼玉医科大学総合医療センター
英語
Saitama Medical Center, Saitama Medical University
日本語
産科麻酔科
英語
Division of Obstetric Anesthesia
350-8550
日本語
埼玉県川越市鴨田1981番地
英語
1981 Kamoda, Kawagoe, Saitama
049-228-3654
mazda@saitama-med.ac.jp
日本語
名 | 祐典 |
ミドルネーム | |
姓 | 松田 |
英語
名 | Yusuke |
ミドルネーム | |
姓 | Mazda |
日本語
埼玉医科大学総合医療センター
英語
Saitama Medical Center, Saitama Medical University
日本語
産科麻酔科
英語
Division of Obstetric Anesthesia
350-8550
日本語
埼玉県川越市鴨田1981番地
英語
1981 Kamoda, Kawagoe, Saitama
049-228-3654
mazda@saitama-med.ac.jp
日本語
埼玉医科大学
英語
Saitama Medical Center, Saitama Medical University
日本語
日本語
日本語
英語
日本語
埼玉医科大学
英語
Saitama Medical Center, Saitama Medical University
日本語
日本語
自己調達/Self funding
日本語
英語
日本語
英語
日本語
英語
日本語
埼玉医科大学総合医療センター倫理委員会
英語
Saitama Medical CenterIRB
日本語
埼玉県川越市鴨田1981番地
英語
1981 Kamoda, Kawagoe, Saitama
049-228-3411
smcrinri@saitama-med.ac.jp
いいえ/NO
日本語
英語
日本語
英語
2014 | 年 | 04 | 月 | 12 | 日 |
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
最終結果が公表されている/Published
https://www.obstetanesthesia.com/article/S0959-289X(18)30171-7/fulltext
30
日本語
両群間の患者背景に有意差は認めなかった.術中そう痒発生頻度は鍼群20.0% vs. コントロール群20.0% (p=1.000),術後2時間後そう痒発生頻度は38.5% vs. 21.4% (p=0.375),術後12時間後そう痒発生頻度は57.1% vs. 53.3% (p=0.772),術後24時間後そう痒発生頻度は6.7% vs. 33.3% (p=0.068)といずれも有意差を認めなかった.そう痒に対するヒドロキシジン使用頻度は6.7% vs. 25.0% (p=0.283)であった.術中・術後の悪心嘔吐発生頻度,術後痛の強さ,患者満足度にも,統計学的に有意な差は認めなかった.
英語
The postoperative incidence of pruritist was 67% vs. 67% in each groups. Likewise, the incidence of intraoperative pruritis was the same.
2021 | 年 | 01 | 月 | 16 | 日 |
日本語
英語
2018 | 年 | 07 | 月 | 27 | 日 |
日本語
The present trial included 30 parturients aged 18-50 years with an American Society of Anesthesiologists physical status of I or II who were scheduled for cesarean section under spinal anesthesia (SA) or combined spinal epidural anesthesia (CSEA) at term (> 37 weeks gestation) from October 2015 to March 2016. The trial was conducted at the Saitama Medical Center, Kawagoe, Japan, which is a tertiary perinatal center. Exclusion criteria were: hypertensive disorders, diabetes mellitus, cardiovascular diseases, neurological diseases, coagulopathies, severe fetal anomalies, skin diseases, pruritus during pregnancy, participation refusal, and the performance of the cesarean section at a time when the acupuncturists were unavailable.
英語
The present trial included 30 parturients aged 18-50 years with an American Society of Anesthesiologists physical status of I or II who were scheduled for cesarean section under spinal anesthesia (SA) or combined spinal epidural anesthesia (CSEA) at term (> 37 weeks gestation) from October 2015 to March 2016. The trial was conducted at the Saitama Medical Center, Kawagoe, Japan, which is a tertiary perinatal center. Exclusion criteria were: hypertensive disorders, diabetes mellitus, cardiovascular diseases, neurological diseases, coagulopathies, severe fetal anomalies, skin diseases, pruritus during pregnancy, participation refusal, and the performance of the cesarean section at a time when the acupuncturists were unavailable.
日本語
Patients were fasted for at least 8 hours before arrival at the operating room. Standard monitoring was performed, including non-invasive blood pressure measurement, electrocardiography, and pulse oximetry. An anesthesiologist inserted a 20 G or 18 G intravenous cannula into a forearm vein, and then administered 10 mg of metoclopramide intravenously. Co-hydration with 0.5-1 L of 6% hydroxyethyl starch 130/0.4 in isotonic saline was administered until delivery. The method of anesthesia (SA or CSEA) was selected at the discretion of the anesthesiologist based on the expected duration of surgery. With the patient in the right lateral decubitus position, neuraxial anesthesia was performed at the L2/3 or L3/4 interspace using a 25 G or 27 G Whitacre spinal needle with an introducer (Unisis Corporation, Tokyo, Japan) for SA, or an 18 G Touhy needle with a 27 G Whitacre spinal needle (CSEcure, Smith Medical Japan, Tokyo, Japan) for CSEA. Both types of anesthesia were induced by intrathecal administration of hyperbaric bupivacaine (12 mg), fentanyl (10 mcg), and preservative-free morphine (150 mcg). In CSEA, the epidural catheter was advanced 3-5 cm in the cephalad direction and fixed without a test dose. Left uterine displacement was continued from induction of anesthesia to delivery of the neonate, and supplemental oxygen was only administered when SpO2 was < 95%. Blood pressure was measured every minute until delivery, and a vasopressor was administered when the mean arterial pressure fell below 70 mmHg or systolic blood pressure fell below 100 mmHg15. Vasopressor selection was dependent on maternal heart rate; phenylephrine (100 mcg) was administered as an intravenous bolus if the maternal heart rate was equal to or greater than 60 bpm, while ephedrine (5 mg) was administered if the maternal heart rate was less than 60 bpm. Vasopressor administration was repeated as needed to restore blood pressure. After the delivery of the neonate, a blinded obstetrician obtained umbilical arterial blood by the double-clamp method after blood gas analysis, and a blinded neonatologist assessed the Apgar score at 1 and 5 minutes.
英語
Patients were fasted for at least 8 hours before arrival at the operating room. Standard monitoring was performed, including non-invasive blood pressure measurement, electrocardiography, and pulse oximetry. An anesthesiologist inserted a 20 G or 18 G intravenous cannula into a forearm vein, and then administered 10 mg of metoclopramide intravenously. Co-hydration with 0.5-1 L of 6% hydroxyethyl starch 130/0.4 in isotonic saline was administered until delivery. The method of anesthesia (SA or CSEA) was selected at the discretion of the anesthesiologist based on the expected duration of surgery. With the patient in the right lateral decubitus position, neuraxial anesthesia was performed at the L2/3 or L3/4 interspace using a 25 G or 27 G Whitacre spinal needle with an introducer (Unisis Corporation, Tokyo, Japan) for SA, or an 18 G Touhy needle with a 27 G Whitacre spinal needle (CSEcure, Smith Medical Japan, Tokyo, Japan) for CSEA. Both types of anesthesia were induced by intrathecal administration of hyperbaric bupivacaine (12 mg), fentanyl (10 mcg), and preservative-free morphine (150 mcg). In CSEA, the epidural catheter was advanced 3-5 cm in the cephalad direction and fixed without a test dose. Left uterine displacement was continued from induction of anesthesia to delivery of the neonate, and supplemental oxygen was only administered when SpO2 was < 95%. Blood pressure was measured every minute until delivery, and a vasopressor was administered when the mean arterial pressure fell below 70 mmHg or systolic blood pressure fell below 100 mmHg15. Vasopressor selection was dependent on maternal heart rate; phenylephrine (100 mcg) was administered as an intravenous bolus if the maternal heart rate was equal to or greater than 60 bpm, while ephedrine (5 mg) was administered if the maternal heart rate was less than 60 bpm. Vasopressor administration was repeated as needed to restore blood pressure. After the delivery of the neonate, a blinded obstetrician obtained umbilical arterial blood by the double-clamp method after blood gas analysis, and a blinded neonatologist assessed the Apgar score at 1 and 5 minutes.
日本語
全ての患者において,研究介入に伴う有害事象は認めなかった.
英語
None
日本語
術後24時間以内の掻痒発生率
英語
The primary outcome was the occurrence of pruritus within 24 hours postoperatively.
日本語
英語
日本語
英語
主たる結果の公表済み/Main results already published
2015 | 年 | 05 | 月 | 01 | 日 |
2015 | 年 | 10 | 月 | 01 | 日 |
2015 | 年 | 10 | 月 | 01 | 日 |
2016 | 年 | 03 | 月 | 20 | 日 |
2016 | 年 | 04 | 月 | 30 | 日 |
2017 | 年 | 05 | 月 | 31 | 日 |
2017 | 年 | 07 | 月 | 31 | 日 |
日本語
英語
2014 | 年 | 04 | 月 | 11 | 日 |
2021 | 年 | 01 | 月 | 16 | 日 |
日本語
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000015987
英語
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015987
研究計画書 | |
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登録日時 | ファイル名 |
2021/01/16 | 研究計画書:円皮鍼・掻痒.docx |
研究症例データ仕様書 | |
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研究症例データ | |
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登録日時 | ファイル名 |