Patients undergoing laparoscopic procedures may experience moderate or even severe postoperative pain, frequently in the abdomen or shoulder region. The origin of this pain may be peritoneal or diaphragm. The intraperitoneal (IP) administration of local anesthetics is controversial but has proven effective in some studies for the relief of postoperative pain. Intraperitoneal injection of opioids for postoperative analgesia has been evaluated as an alternative approach. The aim of this study is to investigate analgesic efficacy intraperitoneal injections of local anesthetic and opioid combination on pain control after diagnostic gynecologic laparoscopy. In this randomized, double blind, and placebo-controlled trial, 100 healthy women undergoing gynecologic laparoscopy for diagnosis of infertility under general anesthesia will be studied. At the end of laparoscopy patients will be randomize to infiltrate 40mL of 0. 25% bupivacaine with 100 µg fentanyl (study group, n=50) or normal saline (placebo group, n=50) intraperitonealy. Visual analogue scale (VAS; 0 to 10), analgesic requirements, and side effects will be recorded every hour for four hours then every four hours for a total of 24 hr postoperatively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212267013N4
Registration date:2013-01-06, 1391/10/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-01-06, 1391/10/17
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Intraperitoneal Infiltration of Bupivacaine and Fentanyl Combination on the Pain Control after Diagnostic Gynecologic Laparoscopy
Public title
Effect of Intraperitoneal Infiltration of Bupivacaine and Fentanyl Combination on the Pain Control after Diagnostic Gynecologic Laparoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients scheduled for diagnostic gynecologic laparoscopy; patients aged 18–40 yr; patients with ASA class I or II.
Exclusion criteria: Patients with a history of allergy to local anesthetics; patients with a history of systemic disease or psychological disorders; patients with a history of chronic pain syndrome; Patients with a history of NSAIDS or any other analgesic consumption.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Vice chancellor for research, Tabriz University of Medical Sceinces, Daneshgah square, Tabriz
City
Tabriz
Postal code
Approval date
2012-11-17, 1391/08/27
Ethics committee reference number
91135
Health conditions studied
1
Description of health condition studied
pain due to diagnostic laparoscopy
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
pain
Timepoint
PACU, every 1 hour until 4 hours and then every 4 hours until 24 hours after operation.
Method of measurement
Visual analogue scale (VAS) from 0 (without pain) to 10 (severe and intolerable pain)
Secondary outcomes
1
Description
Dose of analgesic requirements
Timepoint
PACU, every 1 h until 4 h and then every 4 h until 24 h after operation
Method of measurement
Injection number and injection dose in mg
Intervention groups
1
Description
In the study group(n=50) 40mL of 0. 25% bupivacaine with 100 µg fentanyl is infiltrated intraperitonealy at the end of operation.
Category
Treatment - Drugs
2
Description
In the placebo group(n=50) 40 ml normal saline is infiltrated intraperitonealy at the end of operation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra Hospital, Operation Room and postoperative setting
Full name of responsible person
Dr. Simin Atashkhoei
Street address
Al Zahra hospital, Artesh Jonoubi Ave, Operating room, Dr. Simin Atashkhoyi
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyyed Kazem Shakouri
Street address
Tabriz University, Daneshgah 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, 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. Simin Atashkhoyi
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Al Zahra hospital, Artesh Jonoubi Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
siminatashkhoii@yahoo.comsatashkhoyi@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 Simin Atashkhoyi
Position
Associate Professor, Specialist in َAnesthesiology
Other areas of specialty/work
Street address
Al Zahra Hospital, Artesh Jonoubi Ave,Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
siminatashkhoii@yahoo.comsatashkhoyi@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. Simin Atashkhoyi
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, Artesh Jonoubi Ave, Tabriz
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)