Clinical trial of comparison between transverse abdominal plane block versus local infiltration of anesthesia in post operative laparoscopic pain among Endometriosis patients
This randomized clinical trial is done between 2015 to 2016 at Avicenna and Mohebe Kosar hospital among 75 women with endometriosis and candidate for laparoscopy who are 18 to 50 years old and ASA classification less than 3 which randomize by balanced block randomization. Patients divide in three groups of: TAP block, local infiltration and placebo.TAP block group receive 0.6 milliliter per kilogram normal saline subcutaneously before incision for trocar as placebo and at the beginning 0.6 milliliter per kilogram Bupivacaine 0.25% inject under laparoscopic guide by using needle number 22G between internal oblique and transverse abdominal muscle after negative aspiration and two POP sensation which divide equally in 4 places at right and left side. Local infiltration group receive 0.6 ml per kg Bupivacaine 0.25% subcutaneously before skin incision for trocar in four places with equal volume and at the beginning receive 0.6 milliliter per kilogram normal saline as placebo in equal volume which divide in 4 places between internal oblique and transverse abdominal plane at right and left side. Placebo group receive 0.6 ml per kg normal saline as placebo for local infiltration and transverse abdominal plane. The person who infiltrates drug is a surgeon and blind to the kind of drug. after that demographic of patients, kind of surgery, duration of surgery and pain score which measured by verbal numerical rating scale (VNRAS) is asked at 2 to 4, 6 to 8 ,10 to 12 , and 24 hours after surgery and also asked for nausea, vomiting and analgesia consumption which registered in a form.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015090919373N2
Registration date:2016-03-24, 1395/01/05
Registration timing:na
Last update:
Update count:0
Registration date
2016-03-24, 1395/01/05
Registrant information
Name
Roxana Kargar
Name of organization / entity
Avicenna Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2221 7065
Email address
afsanehnainie@sbmu.ac.ir
Recruitment status
Not enough for processing
Funding source
Avicenna Research Institute
Expected recruitment start date
2016-01-15, 1394/10/25
Expected recruitment end date
2015-08-21, 1394/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison between transverse abdominal plane block versus local infiltration of anesthesia in post operative laparoscopic pain among Endometriosis patients
Public title
The effect of Transverse abdominal plane block and local infiltration of anesthesia in post operative laparoscopic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women between 18 to 50 years old; ASA classification less than 3 ; candidate for elective laparoscopic surgery for endometriosis; take consent for entrance; no addiction to opiate; no companion with other illnesses such as liver, kidney, or psychotic diseases. Exclusion criteria: Tendency of patient for exclusion; allergy to drugs; laparoscopic surgery converted to laparotomy; coagulopathy disease; patients without cooperation; hospitalize less than 24 hours; bowel anastomosis
Age
From 76 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Avicenna
Street address
No 97, Yakhchal avenue, Shariati street
City
Tehran
Postal code
Approval date
2015-11-17, 1394/08/26
Ethics committee reference number
IR.ACECR.Avicenna.REC.1394.12
Health conditions studied
1
Description of health condition studied
Endometriosis of uterus
ICD-10 code
N80.0
ICD-10 code description
Endometriosis of uterus Adenomyosis
2
Description of health condition studied
Endometriosis of ovary
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
3
Description of health condition studied
Endometriosis of fallopian tube
ICD-10 code
N80.2
ICD-10 code description
Endometriosis of fallopian tube
4
Description of health condition studied
Endometriosis of pritoneum
ICD-10 code
N80.3
ICD-10 code description
Endometriosis of pelvic peritoneum
5
Description of health condition studied
Endometriosis of recovagina
ICD-10 code
N80.4
ICD-10 code description
Endometriosis of rectovaginal septum and vagina
6
Description of health condition studied
Endometriosis of intestine
ICD-10 code
N80.5
ICD-10 code description
Endometriosis of intestine
Primary outcomes
1
Description
pain
Timepoint
Severity of post operative pain in 2 to 4 , 6 to 8 , 10 to 12 and 24 hours after surgery
Method of measurement
Ask patients by VNRS scale
Secondary outcomes
1
Description
Nausea
Timepoint
2 to 4, 6 to 8, 10 to 12, and 24 hours after surgery
Method of measurement
Patient expression
2
Description
Vomiting
Timepoint
2 to 4, 6 to 8, 10 to 12, and 24 hours after surgery
Method of measurement
Number of vomiting
3
Description
Morphine consumption
Timepoint
2 to 4, 6 to 8, 10 to 12, and 24 hours after surgery
Method of measurement
miligramme
4
Description
Time of first injection of morphine
Timepoint
2 to 4, 6 to 8, 10 to 12, and 24 hours after surgery
Method of measurement
Hour
5
Description
Complication of injection
Timepoint
2 to 4, 6 to 8, 10 to 12, and 24 hours after surgery
Method of measurement
Yes, No
Intervention groups
1
Description
Transverse abdominal plane block group receive 0.6 milliliter per kilogram normal saline subcutaneously before incision for Trocar as placebo and at the beginning inject 0.6 milliliter per kilogram Bupivacaine 0.25% by using needle number 22G between internal oblique and transverse abdominal muscle after negative aspiration and two POP sensation under laparoscopic guide which divided equally in 4 places at right and left side.
Category
Treatment - Drugs
2
Description
Local infiltration group receive 0.6 milliliter per kilogram Bupivacaine 0.25% subcutaneously at the beginning before skin incision for trocar in four places in equal volume and 0.6 milliliter per kilogram normal saline as placebo under laparosopic guide between internal oblique and transverse abdominal muscle in four places with equal volume in right and left side.
Category
Treatment - Drugs
3
Description
Placebo group receive 0.6 milliliter per kilogram normal saline subcutaneously as placebo in four places in equal volume before skin incision for trocar and then 0.6 milliliter per kilogram normal saline as placebo under laparoscopic guide in four places in equal volume between internal oblique and transverse abdominal plane in right and left side.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Avicenna center and Mohebe Kosar hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Avicenna Research Institute
Full name of responsible person
Haleh Maleki
Street address
Daneshjoo street, Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Avicenna Research Institute
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
Avicenna Research Institute
Full name of responsible person
Roxana Kargar
Position
Obstetrics and Gynecology Specialist
Other areas of specialty/work
Street address
No 5, 3rd Felestin, Felestin, Estanboul, Hasan Akbari, Pole Roumi, Shariati
City
Tehran
Postal code
Phone
+98 21 2221 7065
Fax
Email
roxanakargar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Avicenna Research Institute
Full name of responsible person
Shaheen Khazali
Position
Obstetrics and Gynecology Specialist
Other areas of specialty/work
Street address
No.97, Shariati street, first of Yakhchal Avenue
City
Tehran
Postal code
1964844685
Phone
+44 7952 040416
Fax
Email
s.khazali@me.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Avicenna Research Institute
Full name of responsible person
Roxana Kargar
Position
Obstetrics and Gynecology Specialist
Other areas of specialty/work
Street address
No 5, 3rd Felestin, Felestin alley, Estanboul avenue, Hasan Akbari, Pole Roumi, Shariati street
City
Tehran
Postal code
1964844685
Phone
+98 21 2221 7065
Fax
Email
roxanakargar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)