Comparsion of the effect of dexmedetomidine and bupivacaine with morphine and bupivacaine on block quality in leg fracture surgeries under epidural anesthesia
Comparsion of the Effect of Dexmedetomidine and Bupivacaine with Morphine and Bupivacaine on Block Quality in Leg fracture surgeries under Epidural Anesthesia
Design
Clinical trial with control group, parallel group, double-blind, randomization using a random number table
Settings and conduct
The present study was carried out in the Imam Khomeini hospital, Ahwaz and included 80 patients in the age group of 18 to 60 years. Patients were assigned to receive a lumbar epidural containing bupivacaine0.5%, 12ml+ morphine 2mg/kg, or bupivacaine 0.5% 12ml+dexmedetomidine 1µg/kg.
Participants/Inclusion and exclusion criteria
Entry criteria included:
Patients aged 18-60 years old with anesthesia risk ASA I, II
Exclusion criteria included:
1-Dissatisfaction with the epidural block
2. Patients dependent on each psychiatric drug
3 patients had allergies to the study drugs.
4. Patients with neurological and neuromascular diseases and coagulation disorders.
5. Patients who needed an analgesic drug during surgery.
6. Patients whose epidural blocks failed and under general anesthesia
7-Pregnant women
Intervention groups
Group I consisted of patients who received 12 ml of 0.5% bupivacaine hydrochloride plus dexmedetomidine (B+D) 1µg/kg while Group II patients received 12 ml of 0.5% bupivacaine hydrochloride plus morphine 2mg/kg (B+M)
Main outcome variables
The time to reach of the sensory block is also recorded until the sensory level reaches T12, the duration of the sensory block is recorded as long as the sensory level returns to L5, Also, to evaluate postoperative pain and the time of the first request for analgesia, Visual Analogue Scale (VAS) and sedation score during and after the operation are recorded.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180602039954N1
Registration date:2019-03-10, 1397/12/19
Registration timing:retrospective
Last update:2019-03-10, 1397/12/19
Update count:0
Registration date
2019-03-10, 1397/12/19
Registrant information
Name
Fatemeh Moftakhar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 3372
Email address
goosheh-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion of the effect of dexmedetomidine and bupivacaine with morphine and bupivacaine on block quality in leg fracture surgeries under epidural anesthesia
Public title
Comparsion of the effect of dexmedetomidine with morphine in surgeries under epidural anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-60 years old with anesthesia risk ASA I, II
Exclusion criteria:
Lack of satisfaction with epidural blocking
Patients dependent on any psychiatric drug
Patients with localized infection at the site of the epidural block
Patients who had an allergy to the study drugs.
Patients with neurological and neuro-macular diseases and psychologists
Patients with coagulation disorder
Patients who require an analgesic drug during surgery.
Patients who fail their epidural block and were under general anesthesia
Pregnant women
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization with a random number table is that envelopes are prepared and printed by a member of the research team and random numbers with the help of the Randomaize.com site, and will be embedded in the envelope, and the person will sign the consent form if they wish. Remove an envelope and then open it and enter the intervention or control group based on the contents of the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, responsible for collecting data, data analyzer
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No 9-Edalat Building-West 12th ST-Kian Abad
City
Ahvaz
Province
Khouzestan
Postal code
6155736793
Approval date
2018-02-18, 1396/11/29
Ethics committee reference number
ir.ajums.rec.1396.938
Health conditions studied
1
Description of health condition studied
Leg fracture
ICD-10 code
S82.8
ICD-10 code description
Other fractures of lower leg
Primary outcomes
1
Description
Block Epidural Quality
Timepoint
Epidural block every two minutes until the sensory level reaches T12, then every 15 minutes; motion block every 5 minutes to bromage 3 times every 30 minutes; Sedation Score every 30 minutes; VAS Score every 30 minutes; Bp, HR; Sat O2 every 5 minutes to half an hour every 15 minutes
Method of measurement
Sensory block with cold swab; Motion block with Bromage scale; Postoperative pain using VAS score; Sedation using Ramsay Scale method.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: consisted of patients who received 12 ml of 0.5% bupivacaine hydrochloride plus dexmedetomidine 1µg/kg (B+D).
Category
Treatment - Other
2
Description
Intervention group2: consisted of patients who received 12 ml of 0.5% bupivacaine hydrochloride plus morphine 2mg/kg (B+M).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Mohammad Reza Gousheh
Street address
Azadegan Avenue
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Email
goosheh-m@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badawi
Street address
Deputy of research and technology, Jundishapur University of Medical Sciences, Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Web page address
Grant name
Grant code / Reference number
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
Mohammad Reza Gooshe
Position
Assistant Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Azadegan Ave,Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3311
Email
Goosheh-m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Moftakhar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No:9-Edalat building-West12th St-Kian abad
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3338 3372
Fax
Email
goosheh-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Moftakhar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No:9-edalat building-West12th St-Kian abad
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3338 3372
Fax
Email
goosheh-m@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Documentation of study, Documentation used in the study, Collected data files, Participants' data after unidentifiable person profile
When the data will become available and for how long
Access to documentation and data are possible at the end of 2019.