In this study, 100 candidates for thyroidectomy who are referred to the Amiralam hospital in the age group of 18 to 60 years old are selected. Patients are randomly assigned to cervical plexus and placebo groups using 4 block size.
Settings and conduct
In this study, 100 patients who are candidates for thyroidectomy are referred to the Amiralam Hospital. Patients are randomly assigned to four equal blocks of cervical plexus and placebo using quadruple blocks. In order to blind, the block syringe for the block is prepared by an anesthetist and without an anesthetist's anesthetist who is making a block based on random numbers. Also, ensuring the success of the block in the case group is measured by a collaborator's anesthesiologist by the Pin Prick test and in the case of The failure of the block in the use of the anesthetic substance of the patient is excluded from the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.Patients undergoing thyroidectomy surgery
2.Age between 18 and 60 years
Exclusion criteria:
1.Sensitivity to topical anesthetic drugs
2.Failure of superficial cervical cord block
3.Changed neck anatomy
4.Local infection
Intervention groups
The intervention group included an ultrasound superficial cervical plexus block based on anatomical landmark bilaterally in the posterior region of the middle part of the sternocleidomastoid muscle with ten cc of ropivacaine plus epinephrine 1/200.000 .
In the control group instead of ropivacaine as the local anesthetic 10 cc normal saline as a placebo is used to inject.
Main outcome variables
post operation pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170826035905N1
Registration date:2017-12-27, 1396/10/06
Registration timing:prospective
Last update:2017-12-27, 1396/10/06
Update count:0
Registration date
2017-12-27, 1396/10/06
Registrant information
Name
Nader Ali Nazemian Yazdi
Name of organization / entity
Tehran University of Medical Sciences/Amir Alam Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8830 3621
Email address
nnazemian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of the Sono-guided superficial cervical plexus block on post operative pain of thyroidectomy surgery: A double blind randomized study
Public title
Control of pain after thyroidectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing thyroidectomy surgery
Age between 18 and 60 years
Exclusion criteria:
Sensitivity to topical anesthetic drugs
Failure of superficial cervical cord block
Changed neck anatomy
Local infection
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by 4 block size.
Blinding (investigator's opinion)
Double blinded
Blinding description
double blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Corner of Ghods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-09-02, 1396/06/11
Ethics committee reference number
IR.TUMS.VCR.REC.1396.3306
Health conditions studied
1
Description of health condition studied
post thyroidectomy pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
post operation pain
Timepoint
2,6,12,24 hours after the surgery
Method of measurement
Pain measure ruler
Secondary outcomes
1
Description
nausea and vomotting
Timepoint
2,6,12,24 hours after surgery
Method of measurement
Ask from patient and nurse
2
Description
The amount of analgesic use after surgery
Timepoint
2,6,12,24 hours after surgery
Method of measurement
Nursing report
3
Description
Remifentanyl consumption during operation
Timepoint
End of the operation
Method of measurement
Anesthesia report paper
Intervention groups
1
Description
Intervention group: The intervention group included an ultrasound superficial cervical plexus block based on anatomical landmark bilaterally in the posterior region of the middle part of the sternocleidomastoid muscle with ten cc of 0.2% ropivacaine plus epinephrine 1/200.000 .
Category
Treatment - Drugs
2
Description
Control group: In the control group instead of ropivacaine as the local anesthetic; 10 cc normal saline as a placebo is used to inject.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
AmirAlam Hospital
Full name of responsible person
Dr Nader Ali Nazemian Yazdi
Street address
AmirAlam Hospital, North Saadi Street, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6670 8103
Email
drnnazemian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellorfor Research of Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammaali Sahraeian
Street address
Corner of Ghods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
rcc@tums.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellorfor Research of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nader Ali Nazemian Yazdi
Position
Assistant professor of Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
AmirAlam Hospital, North Saadi Street, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6676 0269
Fax
Email
drnnazemian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nader Ali Nazemian Yazdi
Position
Assistant professor of Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
AmirAlam Hospital, North Saadi Street, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6676 0269
Fax
Email
drnnazemian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nader Ali Nazemian Yazdi
Position
Assistant professor of Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
AmirAlam Hospital, North Saadi Street, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6676 0269
Fax
Email
drnnazemian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
we will send it privately on request
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available