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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014872
Enrollment
80
Registered
2014-08-18
Start date
2014-08-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient for elective cesarean section,with analgesic level is below Th7 five minutes after the spinal anesthesia

Interventions

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

Sponsors

Yokohama City University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Parturient for elective cesarean section Analgesic level is below Th7 five minutes after the spinal anesthesia American Society of Anesthesia(ASA)1-2

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactMitsuko Kinoshita

Yokohama City University School of Medicine Department of anesthesiology and critical care medicine

anesthes@yokohama-cu.ac.jp045-787-2918

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026