Comparison of addition of Dexmedetomidine and fentanyl to Lidocain 2% to para cervical block reduce pain in patients candidates curettage proceeded
Design
The study will be double blind and clinical trial. 132 patients will be randomly divided into 2 groups. The groups will be parallel. The trial phase will be 3.
Settings and conduct
Candidate for curettage in Taleghani Hospital in Arak will be divided into2 groups by simple randomization with envelopes. The study will be double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18 to 40 years old, candidate for curettage up to 14 weeks of pregnancy
Exclusion criteria: Dissatisfaction
Intervention groups
Group 1: Lidocaine solution of 1.5% (5 cc) with dexmedetomidine and 10 micro grams equivalent to 1 millilitre (total 6 millilitre ) will be used for paracervical block
Group 2: Lidocaine solution of 1.5% (5 cc) with Fentanyl in the amount of 50 micro grams equivalent to 1 millilitre (6 millilitre in total) will be used for paracervical block
Main outcome variables
Pain, nausea and vomiting, the amount of drugs consumed
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N162
Registration date:2021-07-18, 1400/04/27
Registration timing:registered_while_recruiting
Last update:2021-07-18, 1400/04/27
Update count:0
Registration date
2021-07-18, 1400/04/27
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
2021-04-21, 1400/02/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comprasion of adition of Dexmedetomidine and fentanyl to Lidocain 2% to reduce intra and post opraion pain in curettage procedered
Public title
Compression of addition of Dexmedetomidine and fentanyl to Lidocain management pain in curettage proceeded
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 40 years old
Candidate for curettage up to 14 weeks of pregnancy
Exclusion criteria:
Dissatisfaction
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random allocation with envelopes in 2 groups A and B. In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome assessor and data analyzer and participant are blind (double blind). Outcome assessor and data analyzer and participant don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-01-31, 1399/11/12
Ethics committee reference number
IR.ARAKMU.REC.1399.319
Health conditions studied
1
Description of health condition studied
curettage
ICD-10 code
O00-O08
ICD-10 code description
Pregnancy with abortive outcome
Primary outcomes
1
Description
Pain
Timepoint
Up to 2 hours after surgery
Method of measurement
Visual analog pain questionnaire
2
Description
Nausea and vomiting
Timepoint
After surgery
Method of measurement
Observation
3
Description
Mean of drugs consumed
Timepoint
After surgery
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Lidocaine solution of 1.5% (5 cc) with dexmedetomidine and 10 micro grams equivalent to 1 milliliter (total 6 milliliter ) will be used for paracervical block
Category
Treatment - Drugs
2
Description
Intervention group: Lidocaine solution of 1.5% (5 cc) with Fentanyl in the amount of 50 micro grams equivalent to 1 milliliter (6 milliliter in total) will be used for paracervical block
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Maryam Shokrpour
Street address
Taleghani hospital, Emam Khomeini street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
Mshokrpour@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
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
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street