Comparing the analgesic efficacy of adding different doses of dexmedetomidine to bupivacaine in ultrasound-guided Transversus Abdominis Plane (TAP) block in patients undergoing open inguinal hernioraphy
This study aims to compare the analgesic efficacy of adding different doses of dexmedetomidine to bupivacaine in ultrasound-guided Transversus Abdominis Plane (TAP) block in patients undergoing open inguinal herniorrhaphy
Design
A double-blind, randomized, phase 3 clinical trial with 3 parallel arms. Each group will contain at least 25 participants (totaling 75 participants).
Settings and conduct
In this study, participants will be assigned to three study groups randomly. The injection will be ultrasound-guided TAP block under the sterile condition and the injection solution is according to their study group. The patient's pain will be assessed 2, 4, 8, 12, and 24 hours after the end of surgery by the use of Visual Analogue Pain Scale. The first time patient needs analgesic will also be recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Undergoing open inguinal herniorrhaphy
Signing the informed consent form
Age between 18 - 75 years
Class 1 or Class 2 according to American Society of Anesthesiologists (ASA) classification.
Exclusion criteria:
History of substance abuse
Presence of pain in the operation site
History of psychological disorders
History of hypertension or anti-hypertensive medication
History of heart disease (Ischemic, Heart valve disease, heart blocks)
History of kidney failure
History of hypersensitivity to the medications intended to be used in the study
Being illiterate or having difficulty understanding Visual Analogue Pain Scale
Intervention groups
There are 3 groups in this study. The injectable solution in each group is 19ml of Bupivacaine combined with dexmedetomidine solution in 1 ml normal Saline with the following concentration:
The first group, 0.5 mcg/kg dexmedetomidine.
The second group, 1 mcg/kg dexmedetomidine.
The third group,1.5 mcg/kg dexmedetomidine.
Main outcome variables
Reported pain level.
Complications and side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190421043336N1
Registration date:2019-09-18, 1398/06/27
Registration timing:registered_while_recruiting
Last update:2019-09-18, 1398/06/27
Update count:0
Registration date
2019-09-18, 1398/06/27
Registrant information
Name
Gilda Talebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2228 6955
Email address
talebi.g@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the analgesic efficacy of adding different doses of dexmedetomidine to bupivacaine in ultrasound-guided Transversus Abdominis Plane (TAP) block in patients undergoing open inguinal hernioraphy
Public title
Analgesic efficacy of dexmedetomidine in patients undergoing inguinal hernioraphy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Signing the informed consent by the patient
Age between 18 - 75 years
Class 1 or Class 2 according to American Society of Anesthesiologists (ASA) physical status classification
Exclusion criteria:
History of substance abuse
Presence of pain in the operation site before surgery
History of psychological disorders
History of high blood pressure or history of anti-hypertensive medication
History of heart disease (Ischemic Heart disease, Heart valve disease, heart blocks)
History of kidney failure
History of hypersensitivity to the medications intended to be used in the study
Being illiterate or lacking the capacity to understand Visual Analogue Pain Scale
Age
From 18 years old to 75 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization works by randomizing participants within blocks such that an equal number are assigned to each treatment. In this study we randomly assign the patients to 6 separate blocks (with equal numbers) and perform the first type of treatment (0.5 mcg/kg dexmedetomidine) on the blocks 1 and 4, the second type of treatment (1 mcg/kg dexmedetomidine) on the blocks 2 and 5, and the third type of treatment (1.5 mcg/kg dexmedetomidine) on the blocks 3 and 6. To achieve the necessary power for the study, each block has at least 13 patients (at least 78 patients total).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind clinical trial, although the patients will be aware of the type of medication that being used for them, they will not know what strength will be used for them. The anesthesiologist will perform the injection according to the patients corresponding treatment group. The questionnaire for evaluating the effectiveness of the treatment will be filled by an anesthesiology resident who is not aware of the patients treatment group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Deputy of Research and Technology of Kurdistan University of Medical Sciences, Pasdaran Boulevard
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2019-03-16, 1397/12/25
Ethics committee reference number
IR.MUK.REC.1397.382
Health conditions studied
1
Description of health condition studied
Inguinal hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
The patient's pain level, assessed by the use of Visual Analogue Pain Scale
Timepoint
At 2, 4, 8, 12, and 24 hours after the end of surgery
Method of measurement
Visual Analogue Pain Scale
2
Description
The first time patient needs analgesic
Timepoint
The first time patient asks for analgesic after the end of surgery
Method of measurement
Number of hours between end of surgery and the first time patient asks for analgesic
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The injectable solution is 19ml of Bupivacaine combined with 0.5 mcg/kg dexmedetomidine solution in 1 ml normal Saline.
Category
Treatment - Drugs
2
Description
Intervention group: The injectable solution is 19ml of Bupivacaine combined with 1 mcg/kg dexmedetomidine solution in 1 ml normal Saline.
Category
Treatment - Drugs
3
Description
Intervention group: The injectable solution is 19ml of Bupivacaine combined with 1.5 mcg/kg dexmedetomidine solution in 1 ml normal Saline.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Karim Naseri
Street address
Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617983476
Phone
+98 87 3361 1252
Fax
+98 87 3361 1221
Email
kowsar@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Ghaderi
Street address
Deputy of Research and Technology of Kurdistan University of Medical Sciences, Pasdaran Boulevard
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4653
Fax
+98 87 3366 4643
Email
Ebrahimghaderi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Karim Naseri
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4664
Email
bihoshi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Karim Naseri
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4664
Email
bihoshi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Gilda Talebi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Kowsar Hospital, Sanandaj, Kurdistan Province, Iran
City
Sanandaj
Province
Kurdistan
Postal code
1941753913
Phone
+98 87 3322 6748
Fax
+98 21 2260 4230
Email
Talebi.g@muk.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
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
Undecided - It is not yet known if there will be 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