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Trial registered on ANZCTR


Registration number
ACTRN12616000838415
Ethics application status
Approved
Date submitted
13/05/2016
Date registered
27/06/2016
Date last updated
22/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Analgesic effect of adding dexmedetomidine and or nitroglycerin (NTG) to lidocaine for intravenous regional anesthesia: a randomized clinical trial.
Scientific title
Analgesic effect of adding dexmedetomidine and or nitroglycerin (NTG) to lidocaine for intravenous regional anesthesia in patients scheduled for forearm surgery.
Secondary ID [1] 289186 0
Nil
Universal Trial Number (UTN)
U1111-1182-8062
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intra and post-operative pain with intravenous regional anesthesia 298743 0
Forearm/hand disorder/accident requiring surgery' 298940 0
Condition category
Condition code
Anaesthesiology 298790 298790 0 0
Anaesthetics
Anaesthesiology 298791 298791 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients will be randomly allocated into four groups (20 patients in each group): group I (lidocaine group; the control group) will receive 3 mg/kg of Lidocaine alone. The other three groups will receive the same amount of Lidocaine plus 1 microgram/kg dexmedetomidine in group II (dexmedetomidine group), 200 microgram nitroglycrin (NTG) in group III (nitroglycerin group) and 1 microgram/kg dexmedetomidine + 200 microgram NTG in group IV (dexmedetomidine-nitroglycerin group). In all groups the study drugs will be diluted with 0.9% normal saline to a total volume of 40 ml and will be prepared in identical syringes by an anesthetist not involved in the study protocol.On arrival to operating room, the patients will be monitored for heart rate (using ECG), oxygen saturation (using pulse oximetry), arterial blood pressure (non -invasive measurement of systolic, diastolic and mean values every 5 minutes) and the baseline values will be recorded. For each patient two intravenous cannulae will be inserted; the first (22-guage or smaller) in a distal vein of the operative hand for slow injection of the study drugs for intravenous regional anesthesia (IVRA) and will be removed immediately after injection of the anesthetic solution, and the second cannula will be inserted in the hand of the contra-lateral side for intraoperative fluid transfusion.
An Esmarch bandage will be used for exsanguination of the operative arm after its elevation for 5 minutes then, a double cuffed pneumatic tourniquet will be wrapped around the upper arm. The proximal cuff will be inflated between 30 and 90 minutes at the discretion of the treating anaesthetist to 100 mm Hg above the systolic pressure of the patient or at least 250 mm Hg. IVRA will be achieved with slow injection of the study solution according to the patient's group. After the onset of sensory and motor block, the distal cuff of the tourniquet will be inflated to 250 mm Hg, and the proximal cuff will be released. Tourniquet pain, will be assessed using visual analogue scale (VAS) score (where o= no pain and 10 = the most severe pain) will be measured and recorded before and 5, 10, 15, 20, 25 and 30 min after injection of anesthetic solution if the VAS more than 3 the patient will receive 50 microgram fentanyl intravenous bolus. After the end of surgery deflation of the cuff will done using a “deflation/re-inflation” technique for 3 cycles of deflation of the cuff for 5 seconds and then re-inflation for 1 minute.
Intervention code [1] 294725 0
Treatment: Drugs
Comparator / control treatment
group I (lidocaine group; the control group) will receive 3 mg/kg of Lidocaine alone diluted with 0.9% normal saline to a total volume of 40 ml.
Control group
Active

Outcomes
Primary outcome [1] 298263 0
Duration of analgesia by review of medical records .
Timepoint [1] 298263 0
from the time of injection of the anesthetic solution to first analgesic requirement
Primary outcome [2] 298264 0
Tourniquet pain, will be assessed using visual analogue scale (VAS) score (where o = no pain and 10 = the most severe pain)
Timepoint [2] 298264 0
will be measured and recorded before and 5, 10, 15, 20, 25 and 30 minutes after injection of anesthetic solution, if the VAS more than 3 patient will receive 50 micrograms fentanyl.
Primary outcome [3] 298269 0
Analgesic consumption by review of medical records
Timepoint [3] 298269 0
in the first 24 h post operation
Secondary outcome [1] 323726 0
Arterial blood pressure using digital sphymomanometer.
Timepoint [1] 323726 0
before and at 5, 10, 15, 20, 25 and 30 min after injection of the anesthetic solution and at 30 min and 2, 4, 6, 12 ,18 and 24 hours after the tourniquet deflation.
Secondary outcome [2] 323727 0
Heart rate using ECG and pulse oximetry.
Timepoint [2] 323727 0
before and at 5, 10, 15, 20, 25 and 30 min after injection of the anesthetic solution and at 30 min and 2, 4, 6, 12 ,18 and 24 hours after the tourniquet deflation
Secondary outcome [3] 323728 0
Occurrence of any complication e.g. nausea, assessed by 5-Point Likert Scale.
Timepoint [3] 323728 0
in the first 24 hours post-operative

Eligibility
Key inclusion criteria
Eighty patients of both sex, aged (20 - 60) years scheduled for hand or forearm surgery, ASA physical status class I and II
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with open fractures of upper limb, sickle cell anemia, peripheral vascular insufficiency, cardiac disease, hypertensive patients, liver or, kidney disease, patients who are taking any analgesia within the previous 24 h, or history of drug allergy, will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patients will be randomly allocated
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
closed envelopes and computer generated random numbers into four groups 20 patients in each group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
Actual
2/06/2016
Date of last participant enrolment
Anticipated
28/06/2018
Actual
30/06/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
4
Final
Recruitment outside Australia
Country [1] 7871 0
Egypt
State/province [1] 7871 0
Tanta, Elgharbia governorate.

Funding & Sponsors
Funding source category [1] 293590 0
Hospital
Name [1] 293590 0
Tanta University Educational Hospital
Country [1] 293590 0
Egypt
Primary sponsor type
Individual
Name
Hoda Alsaid Ahmed Ezz
Address
Elgeesh street, Tanta University Educational Hospital, Tanta, Elgharbia governorate.
postal code:31257
Country
Egypt
Secondary sponsor category [1] 292406 0
Individual
Name [1] 292406 0
Nagat S. El-Shamaa
Address [1] 292406 0
Elgeesh street, Tanta University Educational Hospital, Tanta, Elgharbia governorate.
postal code:31257
Country [1] 292406 0
Egypt
Secondary sponsor category [2] 297952 0
None
Name [2] 297952 0
none
Address [2] 297952 0
none
Country [2] 297952 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295019 0
Ethics committee of the faculty of Medicine Tanta University
Ethics committee address [1] 295019 0
Ethics committee country [1] 295019 0
Egypt
Date submitted for ethics approval [1] 295019 0
10/05/2016
Approval date [1] 295019 0
25/05/2016
Ethics approval number [1] 295019 0
30935/05/16

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52930 0
Prof Hoda Alsaid Ahmed Ezz
Address 52930 0
Elgeesh street, Tanta University Educational Hospital, Tanta, Elgharbia governorate.
postal code:31257
Country 52930 0
Egypt
Phone 52930 0
+20 1222768250
Fax 52930 0
Email 52930 0
hodaezz714@yahoo.com
Contact person for public queries
Name 52931 0
Hoda Alsaid Ahmed Ezz
Address 52931 0
Elgeesh street, Faculty of Medicine, Tanta University Educational Hospital, Tanta, Elgharbia Governorate.
postal code:31257
Country 52931 0
Egypt
Phone 52931 0
+20 1222768250
Fax 52931 0
Email 52931 0
hodaezz714@yahoo.com
Contact person for scientific queries
Name 52932 0
Hoda Alsaid Ahmed Ezz
Address 52932 0
Elgeesh street, Faculty of Medicine, Tanta University Educational Hospital, Tanta, Elgharbia Governorate.
postal code:31257
Country 52932 0
Egypt
Phone 52932 0
+20 1222768250
Fax 52932 0
Email 52932 0
hodaezz714@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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