The Effect of Regional Scalp Block and Pin-Site Infiltration on Heart Rate and Blood Pressure

Assessment of the Effect of Regional Scalp Block and Pin-Site Infiltration on Heart Rate and Blood Pressure in Skull Pinning in Posterior Cervical Fusion Surgery: randomized control trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20110528006617N8

Enrollment

102

Registered

2023-10-29

Start date

2023-11-06

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Posterior cervical fusion surgery.

Interventions

Intervention 1: First intervention group: Regional Scalp Block (RSB) In this group, with a 25-gauge needle, we inject a mixture of 0.5% bupivacaine 0.5% and 2cc dexamethasone (equivalent to 8mg) bilat

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Candidate patients for posterior cervical fusion surgery Age 18 to 65 years Completing the informed consent form American Society of Anesthesiologists I, II

Exclusion criteria

Exclusion criteria: Previous incision and previous history of cervical surgery Allergy to local anesthetic Drug or alcohol addiction

Design outcomes

Primary

Measure	Time frame
Systolic blood pressure. Timepoint: Basic time, from the time of intubation to the time of pinning every 3 minutes and from the time of injection to the time of surgical incision every 3 minutes. Method of measurement: Non invasive blood pressure.;Diastolic blood pressure. Timepoint: Basic time, from the time of intubation to the time of pinning every 3 minutes and from the time of injection to the time of surgical incision every 3 minutes. Method of measurement: Non invasive blood pressure.;Heart rate. Timepoint: Basic time, from the time of intubation to the time of pinning every 3 minutes and from the time of injection to the time of surgical incision every 3 minutes. Method of measurement: electrocardiogram(ECG).	—

Measure

Time frame

Systolic blood pressure. Timepoint: Basic time, from the time of intubation to the time of pinning every 3 minutes and from the time of injection to the time of surgical incision every 3 minutes. Method of measurement: Non invasive blood pressure.;Diastolic blood pressure. Timepoint: Basic time, from the time of intubation to the time of pinning every 3 minutes and from the time of injection to the time of surgical incision every 3 minutes. Method of measurement: Non invasive blood pressure.;Heart rate. Timepoint: Basic time, from the time of intubation to the time of pinning every 3 minutes and from the time of injection to the time of surgical incision every 3 minutes. Method of measurement: electrocardiogram(ECG).

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Secondary

Measure	Time frame
Mean blood pressure. Timepoint: Basic time, from the time of intubation to the time of pinning every 3 minutes and from the time of injection to the time of surgical incision every 3 minutes. Method of measurement: Non invasive blood pressure.;Saturation of Peripheral Oxygen (SPO2). Timepoint: Basic time, from the time of intubation to the time of pinning every 3 minutes and from the time of injection to the time of surgical incision every 3 minutes. Method of measurement: pulse oximetry.	—

Measure

Time frame

Mean blood pressure. Timepoint: Basic time, from the time of intubation to the time of pinning every 3 minutes and from the time of injection to the time of surgical incision every 3 minutes. Method of measurement: Non invasive blood pressure.;Saturation of Peripheral Oxygen (SPO2). Timepoint: Basic time, from the time of intubation to the time of pinning every 3 minutes and from the time of injection to the time of surgical incision every 3 minutes. Method of measurement: pulse oximetry.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrdad Masoudifar

Esfahan University of Medical Sciences

masoudifar@med.mui.ac.ir+98 31 3822 0000

Outcome results

None listed

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