Background:
Shoulder pain after laparoscopic procedures is a frequent complication encountered in Gynecology ward. It is provoked by irritation or injury of the phrenic nerve at the diaphragm surface during CO2 pneumoperitoneum.
Several treatments have been proposed to reduce post laparoscopic shoulder pain. Gabpantin is one of these treatments which was effective in post laparoscopic pain reduction. The prepose of this study is to evaluate the efficacy of perioperative Gabapentin in preventing and attenuating PLSP after laparoscopic ovarian cystectomy.
Material and methods:
This is a prospective, randomized, double-blind study. 40 patients undergoing elective laparoscopic ovarian cystectomy in Women hospital Tehran University of medical science were enrolled in our study from April 2008 to march 2009 according to the inclusion and exclusion criteria. The control group received oral placebo capsules and case group 600 mg Gabapentin 0.5 h before surgery. The intensity of post laparoscopic shoulder pain (PLSP) was recorded by patient using a visual analogue scale (VAS) 2, 6, 12 hours post anesthetic recovery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103166076N1
Registration date:2011-04-26, 1390/02/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-26, 1390/02/06
Registrant information
Name
Sakineh Banifatemi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3318 7924
Email address
banifatemi.s@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2010-09-23, 1389/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Perioperative Gabapentin for Prevention and Attenuation of Postoperative Shoulder Pain After Laparoscopic ovarivan cystectomy
Public title
Perioperative Gabapentin for Prevention and Attenuation of Postoperative Shoulder Pain After Laparoscopic ovarivan cystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
trial inclusion:
patients
1- aged between 18 and70
2- of ASA (American Society of Anesthesia) physical status I–II
3- undergoing elective laparoscopic ovarian cystectomy were enrolled in our study
Trial exclusions:
1) hypersensitivity to any study drugs
2) serious organ disease/dysfunction
3) persistent preoperative pain
4) daily intake, or intake 48 h preoperatively, of any analgesic
5) alcohol/substance abuse
6) a major psychiatric disorder
7) a bleeding disorder
8) peptic ulcer disease
9) asthma/COPD
10) a seizure disorder
11) pervious abdominal surgery
Age
From 18 years old to 70 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Australian New Zealand Clinical Trials Registry
Secondary trial Id
ACTRN12611000269932
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science Ethics Committee
Street address
central organization of tehran university, 16th azar st. Enghelab Ave.
City
Tehran
Postal code
Approval date
2011-03-05, 1389/12/14
Ethics committee reference number
1578/130/د/89
Health conditions studied
1
Description of health condition studied
Laparoscopy - Ovarian Cyst
ICD-10 code
N80.1
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
2, 6, 12 hours post anesthetic recovery
Method of measurement
visual analogue scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
control : Placebo
600mg as premedication
Category
Placebo
2
Description
Drug : Gabapentin
600mg Gabapentin as premedication
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mirzakoochek khan Women Hospital
Full name of responsible person
Street address
Nejatolahi St. Karimkhan Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Miss Rahmani
Street address
Research adminstration of tehran university of medical sciences- Ghods Avenue-Keshavarz Blvd-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
Tehran University of Medical Science
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
Tehran University of Medical Sciences
Full name of responsible person
Sakineh Banifatemi
Position
Resident of Obstericts and Gynecology
Other areas of specialty/work
Street address
No. 17-4th imam hasan All. Nabard St. Piroozi Ave.