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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

Protocol summary

Study aim
Determining the effect of cranial regional block and infiltration at the pin site on heart rate and blood pressure during cranial pinning in patients undergoing posterior neck fusion surgery
Design
Clinical trial with control group, with parallel groups, three-blind, randomized, on 102 patients. The randomization site is used for randomization. https://www.sealedenvelope.com/simple-randomiser/v1/lists
Settings and conduct
This study is a randomized clinical trial. The target population is candidates for elective posterior cervical fusion surgery who referred to Al-Zahra Hospital in 1402. We have three groups, in which in addition to general anesthesia, in one group, bupivacaine and dexamethasone are administered as local injections in the pin-site area, and in the other group, scalp block with the same drugs is performed in 4 areas, and the third group is only under general anesthesia. Patients and people involved in data collection and analysis are not aware of the type of intervention.
Participants/Inclusion and exclusion 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: Previous incision and previous history of neck surgery; Allergy to local anesthetic; Drug or alcohol addiction
Intervention groups
In the first group or group R, a mixture of bupivacaine and dexamethasone is injected bilaterally in 4 areas equally. In the second group or group P, the same amount of bupivacaine and dexamethasone are injected bilaterally at the pinning site. The third group is only under general anesthesia.
Main outcome variables
Systolic blood pressure, diastolic blood pressure, heart rate, Saturation of Peripheral Oxygen, mean blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110528006617N8
Registration date: 2023-10-29, 1402/08/07
Registration timing: prospective

Last update: 2023-10-29, 1402/08/07
Update count: 0
Registration date
2023-10-29, 1402/08/07
Registrant information
Name
Mehrdad Masoudifar
Name of organization / entity
Esfahan University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1268 2007
Email address
masoudifar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2024-02-04, 1402/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The Effect of Regional Scalp Block and Pin-Site Infiltration on Heart Rate and Blood Pressure
Purpose
Treatment
Inclusion/Exclusion 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:
Previous incision and previous history of cervical surgery Allergy to local anesthetic Drug or alcohol addiction
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling in this research is done in two stages. In the first stage, samples will be entered continuously based on the criteria for entering the study. In the second stage, the samples are assigned to groups in the form of a random permutation block design of three groups with blocks of three. In this way, the letter A is for the regional Regional Scalp Block, group B is for the Pin-Site Infiltration, and the letter C is for the regional scalp block group. The control group is considered. Then, all substitution compounds will be extracted from the site below until the sample size reaches the quorum. https://www.sealedenvelope.com/simple-randomiser/v1/lists To avoid bias, this work will be done by someone other than the researcher.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, patients and people involved in data collection and analysis are not aware of the grouping. After obtaining informed consent from eligible patients, they are randomly placed in 3 groups R, P and control, and the patients do not know which group they are in. After general anesthesia, a skilled doctor injects the drug. In the first group, injection is done in 4 areas, in the second group, in two areas. In the third group, no injection is performed. The person collecting the data does not know which group the patient belongs to. The person responsible for analyzing the data does not know which group this data belongs to.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research Faculty of Medicine-Isfahan University of Medical Sciences
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-08-14, 1402/05/23
Ethics committee reference number
IR.MUI.MED.REC.1402.181

Health conditions studied

1

Description of health condition studied
Posterior cervical fusion surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
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

2

Description
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

3

Description
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)

Secondary outcomes

1

Description
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

2

Description
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

Intervention groups

1

Description
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) bilaterally in the 4 areas of the supra-trochlear, supra-orbital, zygomaticotemporal, and auricotemporal nerves with a 25-gauge needle.
Category
Treatment - Drugs

2

Description
Second intervention group: Pin-Site Infiltration (PSI) In this group, a mixture of 0.5% bupivacaine 0.5% and 2cc dexamethasone (equivalent to 8mg) is injected bilaterally at the pinning site with a 25 gauge needle.
Category
Treatment - Drugs

3

Description
Control group: They are only under general anesthesia. General anesthesia includes 1.5 to 2 mg/kg of propofol, 0.03 to 0.05 mcg/kg of fentanyl, and 0.5 mg/kg of atracurium.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Al Zahra Hospital
Full name of responsible person
Mehrdad Masoudifar
Street address
Soffeh Blvd, Isfahan, Isfahan Province
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 0000
Email
alzahra@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
GholamReza Asgary
Street address
Research and Technology Vice-Chancellor; Building No. 4; Isfahan University of Medical Sciences and Health Care Services; Hezar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Masoudifar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
elective operating room, Al Zahra hospital, Soffeh Blvd, Isfahan, Isfahan province
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 0000
Email
masoudifar@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Masoudifar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Al Zahra hospital, Sofeh blv, Isfahan, Isfahan province
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 7898
Email
masoudifar@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Masoudifar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Al Zahra hospital, sofeh Blv, Isfahan, Isfahan province
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 0000
Email
masoudifar@med.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
There is no further information
When the data will become available and for how long
There is no further information
To whom data/document is available
There is no further information
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
There is no further information
What processes are involved for a request to access data/document
There is no further information
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