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Comparison the effects of spinal anesthesia with bupivacaine versus bupivacaine and fentanyl on sensory and motor block in cervical cerclage operation

Comparison the effects of spinal anesthesia with bupivacaine versus bupivacaine and fentanyl on sensory and motor block in cervical cerclage operation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201405157695N5
Enrollment
30
Registered
2014-07-16
Start date
2012-08-22
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

Cervical incompetency. Investigation and management of (suspected) cervical incompetence in a nonpregnant woman

Interventions

Intervention 1: In patients of the first group, 10mg bupivacaine 0.5% (2ml) was injected in subarachnoid space. Intervention 2: In patients of the second group, 5mg bupivacaine 0.5% (1ml) with 10µg fe
Prevention
In patients of the first group, 10mg bupivacaine 0.5% (2ml) was injected in subarachnoid space.
In patients of the second group, 5mg bupivacaine 0.5% (1ml) with 10µg fentanyl (0.2 ml) and 0.8 ml normal saline were injected in subarachnoid space.

Sponsors

Vice-Chancellor for research of Qazvin University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: pregnant woman; cervical cerclage operation; age 18-40 years old; patients consent Exclusion criteria: presence of contraindication to spinal anesthesia; allergy to local anesthetic drugs; allergy to narcotics; positive history of analgesic drugs consumption; positive history of narcotic and sedative drugs consumption

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Level of sensory block. Timepoint: Every 2 min. Method of measurement: Pinprick.;Motor block. Timepoint: Every 2 min. Method of measurement: Bromage score.

Secondary

MeasureTime frame
Headache. Timepoint: Continous monitoring. Method of measurement: By questioneer.;Nausea and vomiting. Timepoint: Continous monitoring. Method of measurement: Visual.;Itching. Timepoint: Continous monitoring. Method of measurement: Visual.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyedeh Masoumeh Hosseini Valami, M.D.

Qazvin University of Medical Sciences

smhosseiniv@qums.ac.ir+98 28 3333 6001

Outcome results

None listed

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