Unique ID issued by UMIN | UMIN000014872 |
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Receipt number | R000017294 |
Scientific Title | A randomized,double-blind, parallel-group multicenter study for the effect of an epidural top up with normal saline in combined spinal epidural anesthesia with isobaric bupivacaine for cesarean section |
Date of disclosure of the study information | 2014/08/18 |
Last modified on | 2018/08/24 12:01:30 |
A randomized,double-blind, parallel-group multicenter study for the effect of an epidural top up with normal saline in combined spinal epidural anesthesia with isobaric bupivacaine for cesarean section
A randomized,double-blind, parallel-group multicenter study for the effect of an epidural top up with normal saline in combined spinal epidural anesthesia with isobaric bupivacaine for cesarean section
A randomized,double-blind, parallel-group multicenter study for the effect of an epidural top up with normal saline in combined spinal epidural anesthesia with isobaric bupivacaine for cesarean section
A randomized,double-blind, parallel-group multicenter study for the effect of an epidural top up with normal saline in combined spinal epidural anesthesia with isobaric bupivacaine for cesarean section
Japan |
Patient for elective cesarean section,with analgesic level is below Th7 five minutes after the spinal anesthesia
Anesthesiology |
Others
NO
We evaluate the efficacy of epidural top up with normal saline in combined spinal epidural anesthesia with isobaric bupivacaine for cesarean section
Safety,Efficacy
Time to reach Th4 on analgesic level(pin prick test),the percentage of patients that attain the analgesic level with Th4,attained maximum analgesic level
Perioperative hemodynamics
Total consumption of vasopressor agent
Total consumption of intraoperative additional analgesic agent
Intraoperative nausea and vomiting
Volume of intraoperative urine, operation time, anesthesia time
Apgar score
Umbilical code blood gas analysis
Post dural puncture headache and post-operative nausea and vomiting
Total consumption of post-operative additional analgesics
Post-operative VAS scale
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
Placebo
2
Treatment
Medicine | Maneuver | Other |
Group for epidural injection with normal saline after 5.5 minutes of intrathecal isobaric bupivacaine
Group for none of epidural injection after intrathecal isobaric bupivacaine
20 | years-old | <= |
45 | years-old | >= |
Female
Parturient for elective cesarean section
Analgesic level is below Th7 five minutes after the spinal anesthesia
American Society of Anesthesia(ASA)1-2
Emergency
Gestational period <37 or >42 weeks
Placenta previa
Multiplets
Severe PIH
Bleeding disorders and coagulopathy
Neuromuscular disease
Spinal disorder with anatomical spinal anomaly
A case of preliminary anesthetic treatment
Body weight => 90kg
Height < 150 and =>171 cm
Major fetal anomaly
Mental retardation
Patient without cooperation
History of allergy to local anesthetics
80
1st name | |
Middle name | |
Last name | Mitsuko Kinoshita |
Yokohama City University School of Medicine
Department of anesthesiology and critical care medicine
3-9 Fukuura, Kanazawku, Yokohama, Kanagawa
045-787-2800
anesthes@yokohama-cu.ac.jp
1st name | |
Middle name | |
Last name | Mitsuko Kinoshita |
Yokohama City University School of Medicine
Department of anesthesiology and critical care medicine
3-9 Fukuura, Kanazawku, Yokohama, Kanagawa
045-787-2918
anesthes@yokohama-cu.ac.jp
Yokohama City University School of Medicine
None
Self funding
NO
横浜市立大学附属病院(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立市民病院(神奈川県)
横浜労災病院(神奈川県)
帝京大学医学部附属溝口病院(神奈川県)
2014 | Year | 08 | Month | 18 | Day |
Unpublished
Completed
2014 | Year | 07 | Month | 10 | Day |
2014 | Year | 08 | Month | 18 | Day |
2014 | Year | 08 | Month | 16 | Day |
2018 | Year | 08 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017294
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