Comparison of the complications spinal analgesia with Spinal-Epidural Analgesia in natural delivery

Comparison of the complications of Labour analgesia with Spinal or Combined Spinal-Epidural Analgesia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160103025821N4

Enrollment

Registered

2018-07-17

Start date

2018-06-15

Completion date

Unknown

Last updated

2018-09-11

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

Conditions

the complications of Labour analgesia.

Interventions

Intervention 1: Intervention group: Spinal analgesia group: during delivery 25 to 50 microgram intrathecal fentanyl injection to L4-L5 as opioid combined with 2.5 milligram bupivacaine to enhance anal

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: There is a possibility of natural birth mother's consent to reduce delivery pain

Exclusion criteria

Exclusion criteria: mother's disinclination to participate Inability to maintain immobility during procedure Coagulation disorders and defects in homeostasis Increased intracranial pressure for any reason Frank infection at the needle site Hypersensitivity to local anesthetics or other medications using in this methods Acute lesions of the central nervous system Maternal hemodynamic instability (hypovolemia, hypotension) Heart diseases that cardiac output is severely limited fetal distress

Design outcomes

Primary

Measure	Time frame
Hypotension. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: Monitoring, Sphygmomanometer tool.;Pruritus. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: History.;Headache. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: History.;Backpain. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: History.;Urinary incontinence. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: History.;Respiratory depression. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute ,after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: PHysical examination.;Complete Spinal Block. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: PHysical examination.;Fetal heart rate. Timepoint: Before the intervention, Immediately after the intervention, Every 5 minutes until delivery, Immediately after delivery. Method of measurement: PHysical examination.	—

Measure

Time frame

Hypotension. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: Monitoring, Sphygmomanometer tool.;Pruritus. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: History.;Headache. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: History.;Backpain. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: History.;Urinary incontinence. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: History.;Respiratory depression. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute ,after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: PHysical examination.;Complete Spinal Block. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: PHysical examination.;Fetal heart rate. Timepoint: Before the intervention, Immediately after the intervention, Every 5 minutes until delivery, Immediately after delivery. Method of measurement: PHysical examination.

—

Secondary

Measure	Time frame
Studied groups. Timepoint: mmediately after the intervention, after 5 minute,after10 minute,after20minute,afer40minute,after60minute,afer1.5hour,after2hour,after3hour,. Method of measurement: check list.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.hojjat Pourfathi

Tabriz University of Medical Sciences

pourfathih@tbzmed.ac.ir+98 41 3441 2000

Outcome results

None listed

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