Effects of two spinal anesthesia approaches in the incidence of headache, backache, and regression of sensory level after operation

Comparison of median and paramedian approaches to spinal anesthesia in terms of the incidence of headache and backache, and the regression of spinal sensory level in patients undergoing elective cesarean section

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2012101711147N1

Enrollment

138

Registered

2013-11-11

Start date

2012-09-05

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

elective caesarean section. Delivery by elective caesarean section

Interventions

Intervention 1: In the first group, a 23- gauge blue needle is inserted at the L4-L5 vertebral level, and lidocaine 5% in a dose of 0.7-1 mg /Kg is injected into the subarachnoid space for spinal anes

Prevention

In the first group, a 23- gauge blue needle is inserted at the L4-L5 vertebral level, and lidocaine 5% in a dose of 0.7-1 mg /Kg is injected into the subarachnoid space for spinal anesthesia with medi

In the second group, a 23-gauge blue needle is inserted at the L4-L5 vertebral level, and lidocaine 5% in a dose of 0.7-1 mg/Kg is injected into the subarachnoid space (Lidocaine: trade name: Xylocain

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- All patients in ASA I and II classes aged 18-45, 2- indication of spinal anesthesia (lack of peripheral neuropathy, needle insertion site infection, coagulopathy) Exclusion criteria: 1- patients of above ASA I and II classes 2- Chronic back pain and headache 3- General anesthesia concurrent with spinal 4- puncture of the dura mater more than one time

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Backache. Timepoint: in the recovery room, every 2 hours after operation; in the ward, every 4 hours after surgery up until 48 hours. Method of measurement: The visual analogue scale (VAS) standard questionnaire will be used to measure backache. In this method, a line with the length of ten centimeters will be used for which one end presupposes numbness and the other end presupposes the worst possible pain. The patient should mark this line to indicate his/her pain severity.;Headache. Timepoint: in the recovery room, every 2 hours after operation; in the ward, every 4 hours after surgery up until 48 hours. Method of measurement: The visual analogue scale (VAS) standard questionnaire will be used to measure headache. In this method, a line with the length of ten centimeters will be used for which one end presupposes numbness and the other end presupposes the worst possible pain. The patient should mark this line to indicate his/her pain severity.	—

Measure

Time frame

Backache. Timepoint: in the recovery room, every 2 hours after operation; in the ward, every 4 hours after surgery up until 48 hours. Method of measurement: The visual analogue scale (VAS) standard questionnaire will be used to measure backache. In this method, a line with the length of ten centimeters will be used for which one end presupposes numbness and the other end presupposes the worst possible pain. The patient should mark this line to indicate his/her pain severity.;Headache. Timepoint: in the recovery room, every 2 hours after operation; in the ward, every 4 hours after surgery up until 48 hours. Method of measurement: The visual analogue scale (VAS) standard questionnaire will be used to measure headache. In this method, a line with the length of ten centimeters will be used for which one end presupposes numbness and the other end presupposes the worst possible pain. The patient should mark this line to indicate his/her pain severity.

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Secondary

Measure	Time frame
Regression of sensory level. Timepoint: 10 minutes to 2 hours after surgery in the recovery room. Method of measurement: sensation of coldness and light touch by alcohol.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGholamreza Sharifzadeh

Birjand University of Medical Sciences

rezamood@yahoo.com+98 56 1443 1183

Outcome results

None listed

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