Protocol summary

Summary
The aim of this study is detecting the prevention effect of sub- diaphragmatic lidocaine infiltration on reliefing shoulder pain in women laparoscopic surgeries under spinal anesthesia. This is a randomized, single blinded, single center study with control group which will be done in Arash women hospital, laparoscopic ward. Women aged 15- 45 years old who referred to infertility clinic in class of 1&2ASA and need laparoscopic surgery for assessing infertility and ectopioc pregnancy will be included the study. Patients with contraindications of spinal, history of abdominal surgery; history of psychological diseases and anxiety and BMI more than 35 will be excluded. Sample size is 76 patients who will be divided into 3 groups with 28 members randomly. Control group will be generally anesthetized. The first intervention group will be anesthetized in spinal position with spraying of 1 cc of 1% lidocaine solvent into sub- diaphragmatic space and, the second intervention group will be anesthetized just in spinal position without lidocaine. The level of pain will be measured in times of 0, 2, 4, 6 and 12 hours after and during the surgery with VAS ( patients will receive paracetamol 6 hours after the surgery routinely and if they have pain, 50 mg pethidine IM will be administered and the dosage will be recorded.If pain score is more than 5 diclofenac suppository will be administered and the dosage will be recorded). Patient satisfaction of anesthesia will be estimated and numbered from 0- 10. The out of bed of patient, vomiting and nausea, headache, using of analgesic and opiod will be compared in 3 groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022226698N1
Registration date: 2016-03-23, 1395/01/04
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-03-23, 1395/01/04
Registrant information
Name
Mahroo Rezaeinejad
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7771 9922
Email address
m-rezaeinegad@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2016-04-19, 1395/01/31
Expected recruitment end date
2016-07-21, 1395/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of general anesthesia and spinal anesthesia with and without lidocaine on pain level following gynecologic laparoscopic surgeries
Public title
Effect of 3 methods of general anesthesia and spinal anesthesia with and without lidocaine on pain after women laparoscopic surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 15-45; women in class of 1&2ASA who need laparoscopic surgery for assessing infertility and ectopioc pregnancy Exclusion criteria: contraindications of spinal, history of abdominal surgery; history of psychological diseases and anxiety; BMI> 35
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
IR.TUMS.REC.1394.1967

Health conditions studied

1

Description of health condition studied
non inflematory disease of women genital
ICD-10 code
(N80-N98)
ICD-10 code description
Diseases of the genitourinary system (N00-N99) Noninflammatory disorders of female genital tract

Primary outcomes

1

Description
Pain after surgery
Timepoint
o, 2, 4, 6 and 12 hours after surgery and in discharge
Method of measurement
Visual analog scale

2

Description
satisfaction of anesthesia method
Timepoint
after discharge
Method of measurement
numbered scale from 0- 10

Secondary outcomes

1

Description
Headache
Timepoint
After surgery till discharge
Method of measurement
Questioneer

2

Description
vomiting and nausea amount
Timepoint
After surgery till discharge
Method of measurement
questioneer

3

Description
The amount of opiod and analgesic drug administration
Timepoint
After surgery till discharge
Method of measurement
Check list

Intervention groups

1

Description
Intervention in first control group: Spinal anesthesia is done by 20 mg Bupivacaine 0/5% and then about 15 minutes after spinal anesthesia, the surgery begins. Before any painful stimuli a rectal diclofenac suppository is administered. Then the gas is entered into the abdomen by a needle in lithotomy position and umbilical trocar is inserted. 10 cc of 1% lidocaine is sprayed into the space below the diaphragm.
Category
Prevention

2

Description
The second intervention group: Spinal anesthesia is done by 20 mg bupivacaine 0/5%.
Category
Prevention

3

Description
Intervention in control group: general anesthesia
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Women's Hospital
Full name of responsible person
Mah-rou Rezaee-Nejad
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences , Deputy of Research
Full name of responsible person
Dr.Younesian
Street address
Qods St, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences , Deputy of Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arash Women 's Hospital , Tehran University of Medical Sciences
Full name of responsible person
Mahroo Rezaeinejad
Position
women specialist
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat High
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
mahroo_r@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arash Women 's Hospital , Tehran University of Medical Sci
Full name of responsible person
Zahra Asgari
Position
associated professor
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
Dr.zahra.asgari@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arash Women 's Hospital , Tehran University of Medical sciences
Full name of responsible person
Mahroo Rezaeinejad
Position
women specialist
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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