Comparing the effect of adding rocuronium and nitroglycerin to ropivacaine in reducing pain and hemodynamic changes in intravenous local anesthesia
Design
The study will be double blind and clinical trial.177patients will be randomly divided into 3 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Candidate patients for forearm surgery in Valiasr hospital in Arak city are divided into 3 groups by randomization using the block method. The study is double-blind and blinding of the analyst and the outcome evaluator and the participant is done.Interventional drugs will be prescribed by an anesthesiologist, but the Bear Block technique and checking the effects and recording data will be done by a specialist assistant who is not aware of the groupings.
Participants/Inclusion and exclusion criteria
Inclusion criteria: candidate for forearm surgery, not suffering from Raynaud's disease, not suffering from sickle cell anemia, no cyanosis of the affected limb, no use of narcotics and psychoactive substances, no contraindications for intravenous anesthesia, no more than one fracture in the body or surgery
Exclusion criteria: the duration of the surgery is more than 90 minutes, for any reason, the local intravenous anesthesia is terminated (ineffective) during the operation, the duration of the operation is less than 30 minutes.
Intervention groups
The nitroglycerin group will be injected with 200 micrograms of nitroglycerin (Iran Caspin Company) along with 0.2% ropivacaine.
The rocuronium group will be injected with 0.06 mg/kg of rocuronium along with 0.2% ropivacaine.
Main outcome variables
Sensory and motor block onset time, average heart rate, average arterial blood pressure, pain, average drug consumption in 24 hours.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N183
Registration date:2023-05-23, 1402/03/02
Registration timing:prospective
Last update:2023-05-23, 1402/03/02
Update count:0
Registration date
2023-05-23, 1402/03/02
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of adding rocuronium and nitroglycerin to ropivacaine in reducing pain and hemodynamic changes in intravenous local anesthesia
Public title
The effect of rocuronium and nitroglycerin in reducing pain in intravenous local anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20-65 years
ASA class I and II
Forearm surgery candidate
Consent to enter the study
Not having Raynaud's disease
Not having sickle cell anemia
No history of allergy to the drugs used in the study
Absence of cyanosis of the affected organ
No use of drugs and psychotropic substances
No contraindications for intravenous anesthesia
The absence of more than one fracture in the body or surgery
Absence of chronic pain syndrome
Absence of neurological disorders in the hand
Exclusion criteria:
The duration of surgery is more than 90 minutes
For any reason, the local intravenous anesthesia is terminated (ineffective) during the operation.
The duration of the operation is less than 30 minutes
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
177
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into2 groups using a permuted balanced block randomization method with the size of blocks 4. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Interventional drugs will be prescribed by an anesthesiologist, but the Bear Block technique and checking the effects and recording data will be done by a specialist assistant who is not aware of the groupings. In this way, due to the lack of knowledge of the patient and the results evaluator about the order of the groups and interventions, the study will be double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2023-05-01, 1402/02/11
Ethics committee reference number
IR.ARAKMU.REC.1402.033
Health conditions studied
1
Description of health condition studied
Forearm fracture
ICD-10 code
M21.83
ICD-10 code description
Other specified acquired deformities of forearm
Primary outcomes
1
Description
Pain
Timepoint
After filling the tourniquet, and at times 15, 30 and 45 and every 15 minutes until the end of the surgery, after emptying the tourniquet every 30 minutes up to 2 hours (minutes 30, 60, 90 and 120) and then every two hours until 12 hours (4, 6, 8, 10 and 12 hours) after emptying the tourniquet
Method of measurement
Visual analog scale of pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The nitroglycerin group will be injected with 200 micrograms of nitroglycerin (Iran Caspin Company) along with 0.2% ropivacaine. The volume of ropivacaine in all groups will be 35 ml (70 mg) and the desired dose of adjuvant drug will be increased to 5 ml with distilled water, and finally the total volume of drug injected in IVRA in each patient will be 40 ml from the venous cannula site in all groups.
Category
Treatment - Drugs
2
Description
Intervention group: The rocuronium(behsan daru) group will be injected with 0.06 mg/kg of rocuronium along with 0.2% ropivacaine. The volume of ropivacaine in all groups will be 35 ml (70 mg) and the intended dose of adjuvant drug will be increased to 5 ml with distilled water, and finally the total volume of drug injected in IVRA in each patient is 40 ml from the venous cannula site in all groups.
Category
Treatment - Drugs
3
Description
Control group: As an adjuvant, 5 ml of normal saline with 35 ml of 0.2% ropivacaine with a total volume of 40 ml will be injected through the venous cannula.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
modir.he@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University Of Medical Sciences
Full name of responsible person
Dr Mehdi Salehi
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
salehi@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University Of Medical Sciences