Protocol summary

Summary
The purpose of this study is postoperative pain management in the patients were randomized to receive transverse abdominis plane block (TAP block) in surgery by injecting local anesthesia. This is a prospective randomized trial in 60 patients, ASA I/ II undergoing unilateral inguinal hernia surgery. Inclusion criteria: Candidates for unilateral inguinal hernia surgery; ASA class I, II Exclusion criteria: Allergic reactions to general anesthesia, Unexpected bleeding; Cardiovascular events; Severe hypertension.The block randomization method is designed to randomize subjects into two groups T and I. All of the patients undergoing general anesthesia. At the end of the surgery group T The Ultrasound-guided Transverse abdominis plane (TAP) block using 20 ml Marcaine 0.25% and adrenaline 1: 200,000 in the surgical area. For group I patients' infiltration of 20 ml 0.25% Marcaine in 1:200000 Adrenalines in the surgery site is done. No routine analgesic is prescribed after the surgery and only if the patients complain of pain and have VAS more than three, 0.1 mg/kg Morphine Sulfate was injected. Patients are visited at 1, 2,4,6,12,18 up to 24 hours after the surgery and the pain score (using VAS 10 score), time of the first request for analgesic, total dose of prescribed analgesic and complications are recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201506226186N11
Registration date: 2015-09-08, 1394/06/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-09-08, 1394/06/17
Registrant information
Name
Bahram Naderi Nabi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3323 4600
Email address
naderi_bahram@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2015-09-25, 1394/07/03
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of control of pain in transverse abdominal muscle blocks method with injections of local analgesia effect at the incision site after unilateral inguinal hernia surgery
Public title
Pain control with transverse abdominal muscle blocks
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Candidates for unilateral inguinal hernia surgery; ASA class I,II Exclusion criteria: Unexpected bleeding;Cardiovascular events; Severe hypertension
Age
From 16 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Guilan University of Medical Sciences
Street address
Shahid Beheshti Freeway
City
Rasht
Postal code
4193833697
Approval date
2015-07-10, 1394/04/19
Ethics committee reference number
IR.GUMS.REC.1394.23

Health conditions studied

1

Description of health condition studied
Femoral hernia (unilateral) NOS
ICD-10 code
K41.9
ICD-10 code description
Unilateral or unspecified femoral hernia, without obstruction or gangrene

Primary outcomes

1

Description
Pain
Timepoint
1, 2, 4, 6, 12, 18 up to 24 hours after surgery
Method of measurement
Visual Analogue Scale (VAS)\Questionnaire

2

Description
Nausea
Timepoint
1, 2, 4, 6, 12, 18 up to 24 hours after surgery
Method of measurement
Yes/No-Questionnaire

3

Description
Drowsiness
Timepoint
1, 2, 4, 6, 12, 18 up to 24 hours after surgery
Method of measurement
Yes/No-Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Tgroup: Transverse abdominis plane (TAP) block with ultrasound using 20 ml Bupivacaine 0.25% and adrenaline 1: 200,000 in the surgical area
Category
Treatment - Drugs

2

Description
I group: infiltration of 20 ml 0.25% Marcain in 1:200000 Adrenalin in the surgery site
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Bahram Naderi Nabi
Street address
Porsina Street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid Beheshti Freeway
City
Rasht
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 of Guilan University of Medical Sciences
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
Guilan University of Medical Sciences
Full name of responsible person
Bahram Naderi Nabi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4139638459
Phone
+98 13 3336 8534
Fax
+98 33368651
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Bahram Naderi Nabi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193955599
Phone
+98 13 3336 8534
Fax
+98 13 3336 8651
Email
NADERI_BAHRAM@YAHOO.COM
Web page address
www.arc.gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedyeh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 3336 8534
Fax
+98 13 3336 8534
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir

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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