Protocol summary

Summary
We designed the present study to investigate whether pre-emptive use of gabapentin 300 mg orally could reduce postoperative pain, nausea and vomiting after hysterectomy. A total of 140 patients whom were candidate for elective abdominal hysterectomy randomly assigned to one of two groups according to the method of treatment: gabapentin or placebo in a double-blind manner before hysterectomy. The inclusion criteria were ASA class I and II, nonmalignant status (benign gynecologic disease), general anesthesia, and body mass index (BMI) of 20 to 30 kg/m2. The exclusion criteria were known allergy against gabapentin, motion sickness, psychiatric disorder, substance abuse, duration of surgery excess 3 hours. Gabpentin or placebo is given to patients about 1 hour before induction of anesthesia. Postoperatively, the pain was assessed on a visual analogue scale (VAS) at 1, 4, 8, 12 and 24 hours at rest. Acetaminophen intravenously was used to treat postoperative pain on VAS score. Total acetaminophen and anti emetic drug consumption in the first 24 hours after surgery was also recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201404158151N6
Registration date: 2014-05-20, 1393/02/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-05-20, 1393/02/30
Registrant information
Name
Ladan Ajori
Name of organization / entity
Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 1694
Email address
ajori@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Science
Expected recruitment start date
2013-12-14, 1392/09/23
Expected recruitment end date
2014-12-14, 1393/09/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of single dose of gabapentin on postoperative pain, nausea and vomiting after abdominal hysterectomy: A double blind randomized clinical trial
Public title
Effects of gabapentin on postoperative pain, nausea and vomiting after hysterectomy
Purpose
Supportive
Inclusion/Exclusion criteria
All patients whom were candidate for abdominal hysterectomy assessed for eligibility to enter the study. The inclusion criteria: ASA class I and II; nonmalignant status (benign gynecologic disease); general anesthesia; body mass index (BMI) of 20 to 30 kg/m2 The exclusion criteria: known allergy against gabapentin; epilepsy; motion sickness; previous treatment with gabapentin; chronic pain syndrome; psychiatric disorder and substance abuse; patients who had received analgesics within 48 hours before surgery; duration of surgery excess 3 hours; trauma of urinary system or bowel within surgery
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
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
Shahid Beheshti University of Medical Science
Street address
Shohada Hospital, Tajrish Square, Valiasr Avenue
City
Tehran
Postal code
10/9/92
Approval date
2013-12-01, 1392/09/10
Ethics committee reference number
1392-1-136-1157

Health conditions studied

1

Description of health condition studied
Effects of gabapentin on postoperative pain
ICD-10 code
N99.9
ICD-10 code description
Postprocedural disorder of genitourinary system, unspecified

Primary outcomes

1

Description
postoperative pain
Timepoint
1 - 4 -8 -12 -24 hours post operation
Method of measurement
questionare, VAS score

2

Description
postoperative nausea and vomiting
Timepoint
within 24 hours post hysterectomy
Method of measurement
questionare

Secondary outcomes

1

Description
side effects of gabapentin
Timepoint
within 24 hours post hysterectomy
Method of measurement
Patient complanit and physical exam

Intervention groups

1

Description
1 hour before induction of anesthesia 1 capsules of gabapentin (300mg) were given to patient by a physician
Category
Treatment - Drugs

2

Description
in control group 1 capsules of placebo similar in shape and size with true drug were given to patient 1 hour before operation by a physician
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Tajrish hospital
Full name of responsible person
Leila Nazari
Street address
Shohada Tajrish Hospital, Tajrish square, Valiasr Avenue
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Seyyed Jalaledin Khoshnevis
Street address
Shohada Hospital, Tajrish Square, Valiasr Avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Science
Full name of responsible person
Leila Nazari
Position
Assissted Professor of Gynecology
Other areas of specialty/work
Street address
Shohada Tajrish Hospital, Tajrish square, Valiasr Avenue
City
Tehran
Postal code
Phone
+98 21 2271 8005
Fax
Email
leynaz@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical SCience
Full name of responsible person
Ladan Ajori
Position
Associated of professor
Other areas of specialty/work
Street address
Shohada hospital, Tajrish Square, Valiasr Avenue
City
Tehran
Postal code
Phone
+98 21 2271 8005
Fax
Email
leynaz@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Leila Nazari
Position
Assissted Professor of Gynecology
Other areas of specialty/work
Street address
Shohada Tajrish Hospital, Tajrish square, Valiasr Avenue
City
Tehran
Postal code
Phone
+98 21 2271 8006
Fax
Email
leynaz@yahoo.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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