Comparing the effect of injecting Bupivacaine alone and in association with dexmedetomidine through transversus abdominis plane (TAP) block with ultrasound-guided on pain and complications after inguinal hernia surgery: A randomized controlled clinical trial
In case of the effectiveness of injecting bupivacaine alone and in combination with dexmedetomidine via transverse abdominis plane (TAP) block under ultrasound guidance for post-operative pain control in inguinal hernia surgery, this method can be used to reduce postoperative pain in this group of patients. Thereby,
helping patients to get out of the bed faster and subsequently reducing hospital stay and reducing medical costs.
Design
The present study is a double-blind, randomized controlled clinical trial of 66 patients with elective inguinal hernia surgery with an average age of 18 to 65 years and ASA class I and II.
A Clinical trial with control group, with parallel groups, double-blind and randomized
Settings and conduct
Razi Hospital Rasht
Participants/Inclusion and exclusion criteria
Inclusion criteria:
18 to 65 years old
Body mass index 35-18 Kilograms per square meter
Lack of drug sensitivity,
No alcohol and drug addiction
Type of surgery including restoration without tension with mesh
ASA class I, II
exclusion criteria:
Surgery lasts more than 2 hours
Need for another surgical procedure during inguinal hernia surgery
Need to get opium in the recovery room
Excessive hemorrhage
Recurrence of hernia
And need for spinal anesthesia
Intervention groups
Injecting bupivacaine in combination with dexmedetomidine via transverse abdominis plane (TAP) block with ultrasound guidance on pain and complications after inguinal hernia surgery
Main outcome variables
Pain control
General information
Reason for update
Acronym
TAP Block
IRCT registration information
IRCT registration number:IRCT20121216011766N5
Registration date:2019-04-21, 1398/02/01
Registration timing:registered_while_recruiting
Last update:2019-04-21, 1398/02/01
Update count:0
Registration date
2019-04-21, 1398/02/01
Registrant information
Name
Hossein Khoshrang
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 0028
Email address
khoshrang@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of injecting Bupivacaine alone and in association with dexmedetomidine through transversus abdominis plane (TAP) block with ultrasound-guided on pain and complications after inguinal hernia surgery: A randomized controlled clinical trial
Public title
Comparison of the effect of bupivacaine injection alone and in association with dexmedetomidine on pain and complications after inguinal hernia surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 65 years old
Body mass index 35-18 kilogram / meter 2
Lack of drug sensitivity
No alcohol and drug addiction
Type of surgery including restoration without tension with mesh
ASA class I,II
Exclusion criteria:
Surgery lasts more than 2 hours
Need for concurrent surgery during inguinal hernia surgery
Need to get opium in recovery room
excessive hemorrhage
Recurrence of hernia
Need for spinal anesthesia
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients eligible for inclusion will be divided into 2 groups using the Blocked Randomization method. One of the nurses of the relevant ward, who is not aware of the implementation of the study will divide the patients into two groups of 33 marked as I and C as the intervention group and control group. Random sequences will be generated using the Random Generator program. Based on the random block method, 15 blocks of four-block and one six-block will be generated for 66 patients. After producing the list, each person will be assigned a dedicated code and will be recognized by this code during the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients eligible for inclusion will be divided into 2 groups of 33 patients marked as I and C (intervention and control group) using the Blocked Randomization method, by One of the nurses of the relevant ward, who is not aware of the implementation of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences and Health Services
Street address
Shahid Beheshti Highway
City
Rasht
Province
Guilan
Postal code
4193833697
Approval date
2019-02-23, 1397/12/04
Ethics committee reference number
IR.GUMS.REC.1397.449
Health conditions studied
1
Description of health condition studied
Transversus abdominis plane (TAP) block with ultrasound guidance on pain and complications after inguinal hernia surgery
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain
Primary outcomes
1
Description
Comparing the effect of injecting Bupivacaine alone and in association with dexmedetomidine through Transversus Abdominis Plane(TAP) Block with ultrasound guidance in pain and complications after inguinal hernia surgery
Timepoint
In the recovery unit (at 0 o'clock) and at 2, 4, 6, 12, 24 hours after surgery, pain intensity will be measured in the two groups with visual analogue scale (VAS).
Method of measurement
In this way, people are asked to show their pain intensity on a 10 cm ruler. no pain will be scored as zero and score 10 is for the highest pain.
Secondary outcomes
1
Description
In 24 hours after surgery that patients are hospitalized in ward , they will be prescribed 0.5 milligram/kilogram of pethidine, if they need painkillers and they state VAS> 3. Also, complications such as nausea, dizziness and vomiting, the first dose and the mean dose of pethidine consumed in the two groups will be investigated.
Timepoint
In the recovery unit (at 0 o'clock) and at 2, 4, 6, 12, 24 hours after surgery
Method of measurement
Nausea, dizziness and vomiting
Intervention groups
1
Description
Intervention group:20 milliliters of bupivacaine 0.5% with 1 milliliter (100 micrograms) of dexmedmotidine (Precedex brand containing 200 microgram / 2 milliliter of drug, HOSPIRA manufacturer reference of the United States of America)
Category
Treatment - Drugs
2
Description
Control group: 20 milliliter bupivacaine 0.5% plus 1 milliliter normal saline
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital Rasht
Full name of responsible person
DR Hossein Khoshang
Street address
Sardar jungal Ave
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3354 2460
Email
khoshrang@gums.ac.ir
Web page address
http://www.gums.ac.ir/rcrdc
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Hoseein khoshrang
Street address
Sardar jungul Avenue
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3354 2460
Email
khoshrang@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Hoseein Khoshrang
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sardar jungel Avenue
City
Rasht
Province
Guilan
Postal code
4139638459
Phone
+98 132238306
Email
hkhoshrang@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hoseein khoshrang
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sardar jungel Ave
City
Rasht
Province
Guilan
Postal code
4139638459
Phone
+98 132238306
Email
khoshrang@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hossein khoshrang
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sardar jungel Ave
City
Rasht
Province
Guilan
Postal code
4139638459
Phone
+98 132238306
Email
hkhoshrang@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results of the research will be publicly available without mentioning the participants' names in the form of a research paper
When the data will become available and for how long
As soon as the article is published, the information will be publicly available in the general format
To whom data/document is available
researchers
Under which criteria data/document could be used
To do research
From where data/document is obtainable
Contact the relevant journal site or email and contact the responsible author
What processes are involved for a request to access data/document
Contact the relevant journal site or email and contact the responsible author