Comparison of adittion of neostigmine or tramadol to 1/5 percent lidocaine with paracervical block in reduce of post operative pain in colporrhaphy
The aim of this study is effect of adding Neostigmine or Tramadol to Lidocaine 1.5 percent in reducing postoperative pain in patients with colporrhaphy under paracervical block in Taleghani Hospital in Arak. Inclusion criteria: age 30-55 years; ASA class 1 and 2.Exclusion criteria: ASA class 3 and 4; failure in paracervical block; duration surgical more than 90 minutes; body mass index more than 35.108 patients divided randomize in the three groups. First group inject Neostigmine 50 microgram (equivalent to 0.5 milliliter) in Lidocaine 1.5 percent, in the second group inject Tramadol 25 milligram (equivalent 0.5 milliliter) in Lidocaine 1.5 percent and in the third group inject 0.5 mililiter Normal Saline in Lidocaine 1.5 percent. Researcher record oxygen saturation, ECG, respiration rate, temperature, blood pressure every 15 minutes during surgery and end of surgery and in recovery. Pain scale record at 2, 6 , 12 and 24 hours after surgery. Researcher record average duration of analgesia for patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016050320258N7
Registration date:2016-05-29, 1395/03/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-29, 1395/03/09
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
Arak University of Medical Science
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of adittion of neostigmine or tramadol to 1/5 percent lidocaine with paracervical block in reduce of post operative pain in colporrhaphy
Public title
Comparison of adittion of neostigmine or tramadol to 1/5 percent lidocaine with paracervical block in reduce of post operative pain in colporrhaphy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:age 30-55 years; ASA class 1 and 2
Exclusion criteria: ASA class 3 and 4; failure in paracervical block; duration surgical more than 90 minutes; body mass index more than 35
Age
From 30 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Postal code
848176941
Approval date
2016-02-22, 1394/12/03
Ethics committee reference number
IR.ARAKMU.REC.1394.298
Health conditions studied
1
Description of health condition studied
Colporrhaphy
ICD-10 code
N81
ICD-10 code description
Female genital prolapse
Primary outcomes
1
Description
temprature
Timepoint
in, end of surgery to 24 hours
Method of measurement
Thermometer
2
Description
oxygen saturation
Timepoint
in, end of surgery to 24 hours
Method of measurement
oxymeter
3
Description
blood pressure
Timepoint
in, end of surgery to 24 hours
Method of measurement
barometer
4
Description
pain
Timepoint
in, end of surgery to 24 hours
Method of measurement
visual Analogue Scale
5
Description
duration of analgesia
Timepoint
after surgery
Method of measurement
minute
Secondary outcomes
empty
Intervention groups
1
Description
First group inject Neostigmine 50 microgram (equivalent to 0.5 milliliter) in Lidocaine 1/5 percent.
Category
Treatment - Drugs
2
Description
Second group inject Tramadol 25 miligeram (equivalent 0.5 cc) in Lidocaine 1/5 percent.
Category
Treatment - Drugs
3
Description
Control group inject 0/5 milliliter Normal Saline in Lidocaine 1/5 percent.
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
Full name of responsible person
Dr Mohammad Rafiee
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University Of Medical Sciences