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Copmarison of ultrasound-guided transabdominus plane block and ilioinguinal-iliohypogastric nerve blocks to control the pain of patients undergoing open inguinal hernia surgery

Protocol summary

Summary
Objectives: Pain after inguinal hernia surgery can be reduced by injection of local anesthetic at the surgical site. Transabdominus plane block is an effective method in reducing pain and morphine administration in the lower abdominal surgeries. Ilioinguinal-iliohypogastric nerve block is also used to reduce the pain after inguinal hernia surgery. Design: Block randomization, without placebo, single center, trial phase 2, including 54 patients under open inguinal hernia surgery. Setting and conduct: Bupivacaine 0.5%, 3 cc (15 mg), injection into the subdural space to induce spinal anesthesia. Participants including major eligibility criteria: All patients who are supposed to undergo undergoing open inguinal hernia surgery. Intervention: Bupivacaine 0.2%, 15 cc (30 mg), ultrasound-guided, injection in 2 cm above the highest point of right iliac crest. Bupivacaine 0.2%, 15 cc (30 mg), ultrasound-guided, nerve block at 2 cm above and 2 cm interior the anterior-superior iliac crest. Main outcome measures: Pain intensity, sedation level, need for additional opioid.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014030816888N1
Registration date: 2014-12-25, 1393/10/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-12-25, 1393/10/04
Registrant information
Name
Soraya Nik-nejadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 2503
Email address
n_zamiri@sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Copmarison of ultrasound-guided transabdominus plane block and ilioinguinal-iliohypogastric nerve blocks to control the pain of patients undergoing open inguinal hernia surgery
Public title
Copmarison of two ultrasound-guided nerve block methods control the pain of patients undergoing hernia surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. Men between 20 to 70 years old 2. Elective surgery Exclusion criteria: 1. Infection in surgery site 2. Sensitivity to study medications 3. Chronic use of non steroidal anti inflammatory drugs
Age
From 20 years old to 70 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 54
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 committee of Iran University of Medical Sciences
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2013-01-29, 1391/11/10
Ethics committee reference number
23098

Health conditions studied

1

Description of health condition studied
Inguinal hernia
ICD-10 code
k40
ICD-10 code description
Inguinal hernia

Primary outcomes

1

Description
Sedation level
Timepoint
Immediately after recovery and in hours 4, 8, 12, and 24 after surgery
Method of measurement
Ramsay score

2

Description
Pain intensity
Timepoint
Immediately after recovery and in hours 4, 8, 12, and 24 after surgery
Method of measurement
Visual analogue scale

3

Description
Need for additional opioid
Timepoint
Immediately after recovery and in hours 4, 8, 12, and 24 after surgery
Method of measurement
Yes or no

Secondary outcomes

empty

Intervention groups

1

Description
Bupivacaine 0.2%, 15 cc (30 mg), made in MYLAN; Saint-priest France. Ultrasound-guided, injection in 2 cm above the highest point of right iliac crest.
Category
Treatment - Drugs

2

Description
Bupivacaine 0.2%, 15 cc (30 mg), MYLAN; Saint-priest France. Ultrasound-guided, nerve block at 2 cm above and 2 cm interior the anterior-superior iliac crest.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool-e Akram hospital
Full name of responsible person
Soraya Nik-nejadi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
Headquarters building, 2nd floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences, Vice Chancellor for 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
Iran University of Medical Sciences
Full name of responsible person
Soraya Nik-nejadi
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 2503
Fax
Email
tab4412@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Soraya Nik-nejadi
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 2503
Fax
Email
tab4412@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Soraya Nik-nejadi
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Phone
00
Fax
Email
tab4412@yahoo.com
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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