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The evaluation effect of sufentanil and bupivacaine compared to bupivacaine alone in the prevention of post-spinal headaches caused by rupture of Dora layer in pregnant women undergoing caesarean section

The evaluation effect of sufentanil and bupivacaine compared to bupivacaine alone in the prevention of post-spinal headaches caused by rupture of Dora layer in pregnant women undergoing caesarean section

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201610162946N8
Enrollment
60
Registered
2016-10-23
Start date
2016-09-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

headache. Drug-induced headache, not elsewhere classified

Interventions

Intervention 1: Spinal anesthesia is performed in sitting position between L4 - L5 spaces with spinal needle Quinke (25 G * 90mm) 12.5 mgbupivacaine with 5 mcg sufentanil used. Intervention 2: Spinal
Treatment - Drugs
Prevention
Spinal anesthesia is performed in sitting position between L4 - L5 spaces with spinal needle Quinke (25 G * 90mm) 12.5 mgbupivacaine with 5 mcg sufentanil used.
Spinal anesthesia is performed in sitting position between L4 - L5 spaces with spinal needle Quinke (25 G * 90mm) 12.5 mg bupivacaine used.

Sponsors

Vice chancellor for reasearch ,Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: In this study, pregnant women 18 to 40 years undergoing elective cesarean section; ASA class I, II (American Society classification ofAnesthesia); BMI of 18.5 to 25 .patiants were entered to this study after giving informed consent. Patients with a history of bleeding disorder, lack of consent to perform spinal anesthesia, infection, migraine, history of seizures, severe preeclampsia, eclampsia, history of back pain and bulky mass in the CNS are excluded.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Headache incidence and intencity. Timepoint: 0 to 7 days after spinal anesthesia. Method of measurement: by visual analogue scale.

Secondary

MeasureTime frame
Vital sign changes. Timepoint: every 2 minute until 10minute then every 5 minute. Method of measurement: by datascope monitor.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mitra Yari

Kermanshah University of Medical Sciences

myari@kums.ac.ir+98 83334334157

Outcome results

None listed

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