Comparison addition morphine and Tramadol to 1.5% lidocaine with para cervical block in reducing of post operative pain in patient candidate curettage
The objective of this study was to compare the level of sedation and postoperative pain in patients submitted to curettage. This study is double blind clinical trial. We enroll 120 women candidate for curettage. We divide patients to three equal groups. We inject 5 milliliter Lidocaine 1.5% plus 1 milliliter morphine (total 6 milliliter) in first group and we inject 5 milliliter Lidocaine 1.5% plus 2 milligram Tramadol (equal 1 milliliter) in second group and we inject 5 milliliter Lidocaine 1.5% plus 1 milliliter normal saline in third group.We record blood pressure, heart rate, O2 saturation in questionnaire every 5 minute during surgery. We evaluate postoperative pain in recovery, 30 and 60 minutes after operation by visual analogue scale .We record time of analgesic request in 24 hours.
Inclusion criteria: age 20-45; ASA class I and II; block by one person; curettage by one person; duration of curettage in 20 minute.
Exclusion criteria: failure in general anesthesia; history of underlying disease; allergy to drug of anesthesia
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110720258N17
Registration date:2017-03-03, 1395/12/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-03, 1395/12/13
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
Vice President of Research , Arak University of Medical Sciences
Expected recruitment start date
2015-10-12, 1394/07/20
Expected recruitment end date
2018-09-29, 1397/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison addition morphine and Tramadol to 1.5% lidocaine with para cervical block in reducing of post operative pain in patient candidate curettage
Public title
Comparison addition morphine and Tramadol to 1.5% lidocaine with para cervical block in reducing of post operative pain in patient candidate curettage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 20 to 45; ASA class I and II; block by one person; curettage by one person; duration of curettage in 20 minute.
Exclusion criteria: failure in general anesthesia; history of underlying disease; allergy to drug of anesthesia
Age
From 20 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomize with random numbers table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2015-09-29, 1394/07/07
Ethics committee reference number
IR.ARAKMU.REC.1394.167
Health conditions studied
1
Description of health condition studied
Curettage surgery
ICD-10 code
o.04
ICD-10 code description
Medical abortion
Primary outcomes
1
Description
pain
Timepoint
in recovery , 30 and 60 minute after surgery
Method of measurement
visual Analogue Scale
2
Description
narcotic drug
Timepoint
after surgery
Method of measurement
miligeram
3
Description
blood pressure
Timepoint
every 5 minute until recovery
Method of measurement
millimeter Hg
4
Description
heart rate
Timepoint
every 5 minute to recovery
Method of measurement
count
5
Description
oxygen saturation
Timepoint
every 5 minute to recovery
Method of measurement
percent
Secondary outcomes
empty
Intervention groups
1
Description
We injected millimeter lidocaine 1.5% plus 1 millimeter morphine (total 6 millimeter) in first group.
Category
Treatment - Drugs
2
Description
We injected 5 millimeter lidocaine1.5% plus 2 milligram Tramadol (equal 1 millimeter) in second group.
Category
Treatment - Drugs
3
Description
We injected 5 millimeter lidocaine 1.5% plus 1 millimeter normal saline administrated for paracervical block in third group.
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
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences