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Trial registered on ANZCTR


Registration number
ACTRN12611000269932
Ethics application status
Approved
Date submitted
8/03/2011
Date registered
14/03/2011
Date last updated
18/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Perioperative Gabapentin for Prevention and Attenuation of Postoperative Shoulder Pain After Laparoscopic ovarian cystectomy
Scientific title
Perioperative Gabapentin for Prevention and Attenuation of Postoperative Shoulder Pain After Laparoscopic ovarian cystectomy
Secondary ID [1] 253595 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparoscopy - Ovarian Cyst 261151 0
Condition category
Condition code
Anaesthesiology 259310 259310 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug : Gabapentin
600mg oral cap Gabapentin as premedication only once before laparascopy
premedication : treatment occurs before the elective laparoscopic ovarian cystectomy
Intervention code [1] 258017 0
Treatment: Drugs
Intervention code [2] 264188 0
Prevention
Comparator / control treatment
control : Placebo (the same as the treatment drug in appearance and taste but containing no active ingredient)

oral cap as premedication only once before laparascopy
Control group
Placebo

Outcomes
Primary outcome [1] 262112 0
Pain (clinical assessments)
Timepoint [1] 262112 0
2, 6, 12 hours post anesthetic recovery
Secondary outcome [1] 273187 0
nil
Timepoint [1] 273187 0
nil

Eligibility
Key inclusion criteria
patients with
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
Minimum age
18 Years
Maximum age
70 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3179 0
Iran, Islamic Republic Of
State/province [1] 3179 0
Tehran

Funding & Sponsors
Funding source category [1] 258482 0
University
Name [1] 258482 0
Tehran University of Medical Science
Address [1] 258482 0
Tehran University of Medical Siences
school of medicine
P.O.BOX : 14155-6447 zipcode: 1417613151 Tehran, I.R. of Iran
Country [1] 258482 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tehran University of Medical Science
Address
Tehran University of Medical Siences
school of medicine
P.O.BOX : 14155-6447 zipcode: 1417613151 Tehran, I.R. of Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 257623 0
None
Name [1] 257623 0
Address [1] 257623 0
Country [1] 257623 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260459 0
Iran Ethics committee
Ethics committee address [1] 260459 0
Ethics committee country [1] 260459 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 260459 0
Approval date [1] 260459 0
05/03/2011
Ethics approval number [1] 260459 0
89/130/1578

Summary
Brief summary
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 purpose 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.
Results:
There was no statistical significant difference between 2 groups in clinical characteristics.
Duration of laparoscopy was similar in Gabapentin and placebo group.
The frequency of post laparoscopic shoulder pain (PLSP) was (45%) in Gabapentin group and (75%) in placebo group (p=0.05)
Post laparoscopic shoulder pain (PLSP) intensity in Gabapentin group was significantly lower than placebo group (p=0.004). We did not observe any adverse effect.
Conclusion: 600mg Gabapentin as premedication was significantly effective in reducing post laparoscopic shoulder pain intensity after gynecologic laparoscopy compared with placebo without any adverse effect.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32203 0
Address 32203 0
Country 32203 0
Phone 32203 0
Fax 32203 0
Email 32203 0
Contact person for public queries
Name 15450 0
Sakineh Banifatemi
Address 15450 0
No. 17-4th imam hasan All. Nabard St. Piroozi Ave. Tehran Iran. Postcode: 17676-15873
Country 15450 0
Iran, Islamic Republic Of
Phone 15450 0
+98 09123846749
Fax 15450 0
Email 15450 0
banifatemi.s@gmail.com
Contact person for scientific queries
Name 6378 0
Sakineh Banifatemi
Address 6378 0
No. 17-4th imam hasan All. Nabard St. Piroozi Ave. Tehran Iran. Postcode: 17676-15873
Country 6378 0
Iran, Islamic Republic Of
Phone 6378 0
+98 09123846749
Fax 6378 0
Email 6378 0
banifatemi.s@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary