Protocol summary

Study aim
Comparison the effect of ketamine-lidocaine and fentanyl-lidocain on postoperative analgesia in axillary block with Ultrasound Guide in upper limb fractures
Design
The study is design as a randomised, controlled, parallel group trial with double blinded outcome assessment. Randomisation was centralised based on randomized block randomization method.
Settings and conduct
Sixty patients candidate of orthopedic surgery of forearm and hand fractures in age group 18 to 75 years are randomly divided into intervention (1) and (2) group. Using an ultrasound device, the neural network is identified and a sterile needle with ultrasound-guided is imported in the axillary space, then medication is injected around the neural network. Pinprick test and three-point scale test are used to evaluate the sensory and motor block of the median, ulnar, radial and musculocutaneous nerves.
Participants/Inclusion and exclusion criteria
Inclusion criteria are patients under orthopedic surgery of forearm and hand fractures in age group 18 to 75 years and ASA Class I , II; The exclusion criteria are allergic reaction to drugs used in the study, patients with anemia or bleeding disorders, infection of block location, nerve damage of the limb caused by trauma, neuropathy and addiction to narcotics.
Intervention groups
In the Intervention group (1), patients are received 4mg/kg lidocaine 1% and 50mcg fentanyl during axillary block and in the intervention group (2), patients are received 4mg/kg lidocaine 1% and 30 mg ketamine during axillary block.
Main outcome variables
The time of completion of the sensory and motor block are recorded every 15 minutes after the patient enters the recovery room. Postoperative pain in 0, 1, 2, 4, 8, 16 and 24 hours after surgery, the first time of request for narcotic and the amount of narcotic consumption after surgery are measured.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181220042064N1
Registration date: 2019-02-25, 1397/12/06
Registration timing: registered_while_recruiting

Last update: 2019-02-25, 1397/12/06
Update count: 0
Registration date
2019-02-25, 1397/12/06
Registrant information
Name
Bahram Mohammad Tasbihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8383
Email address
tasbihi.b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Ketamine-Lidocaine and Fentanyl-Lidocain on Postoperative Analgesia in Axillary Block with Ultrasound Guide in upper Limb Fractures
Public title
The Effect of Ketamine-Lidocaine and Fentanyl-Lidocain on Postoperative Analgesia in Axillary Block with Ultrasound Guide in upper Limb Fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients under orthopedic surgery of forearm and hand fractures Age group 18 to 75 years American Society of Anesthesiologists (ASA) classification I , II
Exclusion criteria:
Allergic reaction to drugs used in the study Patients with anemia or bleeding disorders Infection of block location Nerve damage of the limb caused by trauma Neuropathy and addiction to narcotics Patient dissatisfaction
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly divided into two groups based on randomized block randomization method. Randomized blocks are used for this purpose. A random sample based on this method from Sealedenvelope.com has been extracted.
Blinding (investigator's opinion)
Double blinded
Blinding description
Surgeon, responsible for collecting data and data analyzer are unaware of the grouping of patients.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Research deputy, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.AJUMS.REC.1397.023

Health conditions studied

1

Description of health condition studied
Fracture of upper limb
ICD-10 code
T10
ICD-10 code description
Fracture of upper limb, level unspecified

Primary outcomes

1

Description
Postoperative pain
Timepoint
0 (immediately after admission to recovery room), 1, 2, 4, 8, 16 and 24 hours after the completion of the surgical operation
Method of measurement
Visual Analogue Scale (VAS)

2

Description
The time of completion of the sensory block
Timepoint
Every 15 minutes after the patient enters the recovery room
Method of measurement
Pinprick test

3

Description
The time of completion of the motor block
Timepoint
Every 15 minutes after the patient enters the recovery room
Method of measurement
Three-point scale test

4

Description
The first time of request for narcotic after surgery
Timepoint
From entering the patient to the recovery room for up to 24 hours after surgery
Method of measurement
According to hour

5

Description
The amount of narcotic consumption after surgery
Timepoint
From entering the patient to the recovery room for up to 24 hours after surgery
Method of measurement
The dose of pethidine (mg/kg)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group (1): Patients are received 4 mg/kg lidocaine 1% and 50 mcg fentanyl during axillary block.
Category
Treatment - Drugs

2

Description
Intervention group (2): Patients are received 4 mg/kg lidocaine 1% and 30 mg ketamine during axillary block.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Reza Akhondzadeh
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 2925
Email
Rezaakh@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi, PhD
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
PAIN-9701
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Bahram Mohamad Tasbihi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61329235893
Email
Tasbihi.b@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Akhondzadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61329235893
Email
Rezaakh@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Bahram Mohamad Tasbihi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital, Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61329235893
Email
Tasbihi.b@ajums.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
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