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The effects of preoperative administration of oral gabapentin on postoperative pain after abdominal hysterectomy

Protocol summary

Summary
The purpose of this study was to evaluate the effects of preoperative administration of oral gabapentin on postoperative pain after surgery in the women undergoing general anesthesia for abdominal hysterectomy in Shahid Sadoughi hospital in Yazd, Iran. In this randomized double blind trial, 60 women, aged 40-60 years old, and ASA physical status I and II, were assigned into one of the following two groups to receive gabapentin, 100 microgram the night before and then 300 microgram 2 hours before surgery, orally in the intervention group or placebo in the control group. Pain was assessed through visual analog scale (VAS) at 1, 6, 12, and 24 hours after the surgery. In addition, the first request of the patient for analgesia, the amount of morphine consumed, and side effects of gabapentin (dizziness, blurred vision, tremor, ataxia, nistagmus, nausea, vomiting) were evaluated during 24 hours and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138810122963N1
Registration date: 2011-04-23, 1390/02/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-04-23, 1390/02/03
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of preoperative administration of oral gabapentin on postoperative pain after abdominal hysterectomy
Public title
Evaluation of the effects of preoperative administration of oral gabapentin on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with American Society of Anesthesia (ASA) physical status I or II who are candidate for elective abdominal hysterectomy, age 40-60 years old, BMI Exclusion criteria: Anaphylaxis reaction to the anesthetic drugs, duration of the operation longer than 2 hours
Age
From 40 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
Shahid Sadoughi University of Medical Sciences
Street address
Bahonar square
City
Yazd
Postal code
Approval date
2010-02-17, 1388/11/28
Ethics committee reference number
107684

Health conditions studied

1

Description of health condition studied
Gabapentin
ICD-10 code
Y46.6
ICD-10 code description
Other and unspecified antiepileptics

Primary outcomes

1

Description
postoperative pain
Timepoint
1,6,12,24 hours postoperatively
Method of measurement
visual analog pain score

2

Description
the first request of the patient for analgesic
Timepoint
during 24 hours after operation
Method of measurement
in hours

3

Description
opioid (morphine) consumption
Timepoint
during 24 hours after operation
Method of measurement
mg morphine

Secondary outcomes

1

Description
side effects of gabapentin (dizziness, blured vision, tremor, ataxia, nistagmus, nausea, vomitting)
Timepoint
1, 6, 12 and 24 hours after operation
Method of measurement
asking the patient, physical examination

2

Description
systolic and diastolic blood pressures
Timepoint
1, 6, 12 and 24 hours after operation
Method of measurement
In mnHg by Sphyngomanometer

3

Description
heart rates
Timepoint
1, 6, 12 and 24 hours after operation
Method of measurement
beats per minute in P/E

Intervention groups

1

Description
gabapentin, 100 microgram, orally, the night before and then 300 microgram 2 hours before surgery
Category
Treatment - Drugs

2

Description
placebo at the same time
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr. Shekoufeh Behdad
Street address
Shahid Sadoughi Hospital, Yazd, Iran
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Hasan Mozaffari
Street address
Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Shekoufeh Behdad
Position
Assistant of professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4104
Fax
Email
drbehdad@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Shekoufeh Behdad
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4104
Fax
Email
drbehdad@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Shekoufeh Behdad
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4104
Fax
Email
drbehdad@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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