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Bupivacaine effect on transient neurologic syndrome after cesarean section

Effect of Baricity of Bupivacaine on Frequency of Transient Neurologic Syndrome (TNS) after Spinal Anesthesia for Cesarean Section

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201612237013N16
Enrollment
230
Registered
2016-12-23
Start date
2016-12-30
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

Epidural analgesia quality. Other complications of spinal and epidural anaesthesia during labour and delivery

Interventions

Intervention 1: Study group: will receive 10 mg 0.5% isobaric bupivacaine combined with 20 µg fentanyl, in total volume of 2.2 ml. Intervention 2: Control group: will receive 10 mg hyperbaric bupivaca
Treatment - Drugs
Study group: will receive 10 mg 0.5% isobaric bupivacaine combined with 20 µg fentanyl, in total volume of 2.2 ml.
Control group: will receive 10 mg hyperbaric bupivacaine combined 20 µg fentanyl, in total volume of 2.2 ml.

Sponsors

Tabriz Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: pregnant women candidate for cesarean section under epidural analgesia; Class I or II according to ASA classification. Exclusion criteria: contraindications for epidural analgesia; sensitivity to local analgesics; history of neurovascular or neuromuscular diseases; history of diabetes; history of mental disorders; intervertebral disc hernia or spinal stenosis; lower extremity neuropathy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Time of TNS symptoms onset. Timepoint: 6 to 48 hours after operation. Method of measurement: physical examination.;Duration of TNS symptoms after analgesia recovery. Timepoint: 6 to 48 hours after operation. Method of measurement: physical examination.;Pain severity due to TNS. Timepoint: 6 to 48 hours after operation. Method of measurement: visual analogue scale.

Secondary

MeasureTime frame
Type of treatment used to treat TNS. Timepoint: 6 to 48 hours after operation. Method of measurement: clinical document.;Dosage of treatment used for TNS recovery. Timepoint: 6 to 48 hours after operation. Method of measurement: clinical document.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Simin Atashkhoyi

Tabriz Medical University

atashkhoii@tbzmed.ac.ir+98 41 3553 9161

Outcome results

None listed

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