Protocol summary

Summary
Nowadays, gynecologic surgeries are one of the most common procedures in the outpatient settings and are performed progressively with laparoscopy. However, acute pain is a most important postoperative complication and not only, can lead to patient discomfort and unsatisfying, but also result to delayed discharge, hospital admission and increased costs. Severity of post laparoscopic pain is moderate to severe and about 35% to 65% of patients experienced it as abdominal or shoulder tip pain and up to 80% of patients required analgesia. Lidocaine has antihyperalgic and anti inflammatory effects and use of this drug in the perioperative period can be a useful approach for post laparoscopic pain control. After given informed consent, all patient's will randomly allocate in one of the lidocaine or placebo groups. With induction of anesthesia, lidocaine group will receive lidocaine infusion in the rate of 2mg/kg/h and placebo group will only receive normal saline in the same infusion rate. After completion of surgery and extubation, pain severity will be evaluate with visual analogue scale (VAS) scoring system in recovery and 2.4,6,12 and 24 hours postoperatively. Postoperative pain with VAS≥4 will be controlled with 0.5/kg intravenous Meperidine. Pain severity, time to first analgesic request, total analgesic consumption doses and any probable postoperative complications will be recorded and statistically analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014040511700N5
Registration date: 2014-08-20, 1393/05/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-20, 1393/05/29
Registrant information
Name
Farnaz Moslemi Tabrizi
Name of organization / entity
Alzahra hospital, Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
moslemif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz university of Medical Sciences
Expected recruitment start date
2014-04-05, 1393/01/16
Expected recruitment end date
2015-04-05, 1394/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preventive lidocaine treatment on postoperative pain control
Public title
Evaluation of the effect of perioperative intravenous infusion of lidocaine in postoperative pain management in women under gynecologic laparoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Women candidate for Gynecologic Laparoscopic surgery; patients with ASA physical status I and II Exclusion criteria: Patient's with ASA class III or above; women with cardiovascular; respiratory diseases; hepatic or renal dysfunction; endocrine disorders; hypertension; psychologic disorder; convulsion; algeria to lidocaine; patients who received opioid or non opioid analgesic preoperatively
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethics Committee of Vice chancellor for research, Tabriz University of Medical Sciences
Street address
Tabriz university of Medical Sciences, Golgasht Ave, Tabriz
City
Tabriz
Postal code
Approval date
2014-02-12, 1392/11/23
Ethics committee reference number
92192

Health conditions studied

1

Description of health condition studied
Postoperative pain after laparoscpy
ICD-10 code
R50,R51,R5
ICD-10 code description
Acute pain

Primary outcomes

1

Description
Pain
Timepoint
2, 4, 6, 12, 24 hours postoperative
Method of measurement
Visual Analog Scale (VAS)

Secondary outcomes

1

Description
Rescue analgesic consumption after surgery
Timepoint
24 hours postoperative
Method of measurement
Total dose mg

2

Description
The first analgesia administration
Timepoint
The time to the first analgesia administration
Method of measurement
Hours

Intervention groups

1

Description
With induction of anesthesia, lidocaine group will receive lidocaine infusion in the rate of 2mg/kg/h
Category
Prevention

2

Description
Control group will only receive normal saline in the same volume and infusion rate.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr. Farnaz Moslemi
Street address
Alzahra Hospital, South Artesh Ave, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz university of Medical Sciences
Full name of responsible person
dr.Hassan Solaimanpour
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Tabriz
City
Tabriz
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 Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. farnaz Moslemi
Position
Associate Professors of Anesthesiology
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
Moslemifa@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farnaz Moslemi
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 55 39161
Fax
+98 41 1556 6449
Email
moslemifa@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farnaz Moslemi
Position
Associated Professor of Anesthesiology
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1556 6449
Fax
+98 41 1556 6449
Email
moslemifa@gmail.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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