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Comparison of two different doses of intrathecal ropivacaine in patients undergoing cesarean section

Comparison of two different doses of intrathecal ropivacaine on onset and duration of sensory and motor block in patients undergoing cesarean section with spinal anesthesia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210114050036N1
Enrollment
66
Registered
2021-04-17
Start date
2018-09-23
Completion date
Unknown
Last updated
2021-04-26

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

Conditions

Investigation of the onset and duration of sensory and motor blocks in the administration of two different doses of intrathecal ropivacaine.

Interventions

Intervention 1: Intervention group: 30 mg rupivocaine 0.5% made by Molteni company with a volume of 6 cc was injected intrathecally in the L4-L5 space. Intervention 2: Intervention group: 20 mg rupivo

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Term pregnancy ASA Class 1 Candidates for non-emergency cesarean section under the spinal anesthesia

Exclusion criteria

Exclusion criteria: Fetal anomalies Heart, liver, kidney or cerebrovascular diseases Preeclampsia and eclampsia Weighting less than 50 kg or more than 100 kg Sensitivity to any of the drugs used in the study For any reason that the patient needs general anesthesia Patient dissatisfaction for entering to the study

Design outcomes

Primary

MeasureTime frame
Onset and duration of sensory block. Timepoint: Examine the sensory level in first minute and then every 2 minutes to 15 minutes and then every 15 minutes to an hour, then every 10 minutes until the sensory level returns to T10. Method of measurement: Pin-prick test using a 22 Gauge needle.;Onset and duration of motor block. Timepoint: Investigation of the motor block in first minute and then every 2 minutes to 15 minutes and then every 15 minutes to an hour, then every 10 minutes until motor block return to a scale lower than the maximum movement block created. Method of measurement: Modified Bromage scale.

Secondary

MeasureTime frame
Systolic, diastolic and mean arterial pressure. Timepoint: At the beginning of study (before the intervention) and then every 3 minutes until the baby was born and then every 5 minutes until the end of surgery. Method of measurement: Non-invasive blood pressure monitoring.;Heart rate. Timepoint: Continuously from the beginning of the study (before the intervention) until the end of surgery. Method of measurement: Electrocardiogram monitoring.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojdeh Niknafs

Yazd University of Medical Sciences

mh.yavari@shahed.ac.ir+98 35 3725 8222

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026