1. Home
  2. Approved trials
  3. » فارسی

Effect of oral gabapentin versus placebo on pain relief after gynecologic surgery: a triple blinded randomized clinical trial

Protocol summary

Summary
Objectives: To assess the effect of oral gabapentin versus placebo on pain relief after gynecologic surgery. Design: A triple blinded randomized clinical trial. Setting and conduct: All eligible patients candidate for gynecologic surgery with hypogastric incision (hysterectomy, myomectomy, and ovarian cyst) who will refer to clinic of Besat Hospital during the study period will be enrolled in to the trial. Inclusion criteria: (a) age of 18 to 65 years; (b) women with physical class ASA I-II; (c) candidate for elective gynecologic surgery. Exclusion criteria: (a) contraindication for neuroaxial anesthesia; (b) history of hypertension or diabetes mellitus; (c) using narcotics or psychotropic. Intervention: (a) 34 patients will receive two gabapentin capsules 300 mg (600 mg) single dose 2 hours before surgery; (b) 34 patients will receive one gabapentin capsule 300 mg plus one placebo capsule (containing starch) single dose 2 hours before surgery. Control: 34 patients will receive two placebo capsules (containing starch) single dose 2 hours before surgery. Primary outcome: (a) pain severity at surgical site at 1, 6, 12, 18, 24, and 48 hours after surgery using VAS scale; (b) the amount of narcotic used during the first 48 hours after surgery per mg; (c) the duration of time to receive narcotic the first narcotic during the first 48 hours after surgery per min. Secondary outcome: (a) vertigo at 1, 6, 12, 18, 24, and 48 hours after surgery by question; (b) nausea and vomiting at 1, 6, 12, 18, 24, and 48 hours after surgery by question; (c) pruritus at 1, 6, 12, 18, 24, and 48 hours after surgery by question.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201402289014N28
Registration date: 2014-05-26, 1393/03/05
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-05-26, 1393/03/05
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral gabapentin versus placebo on pain relief after gynecologic surgery: a triple blinded randomized clinical trial
Public title
Effect of oral gabapentin versus placebo on pain relief after gynecologic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) age of 18 to 65 years; (b) women with physical class ASA I-II; (c) candidate for elective gynecologic surgery. Exclusion criteria: (a) contraindication for neuroaxial anesthesia; (b) history of hypertension or diabetes mellitus; (c) using narcotics or psychotropic.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be assign randomly to one the three trial groups using balance block randomization with the block of six. Blinding: The patients will receive capsules with the same shape but different content (gabapentin or starch), thus, they will not aware of the intervention. In addition, the physician who will examine the patients and the analyzer who will perform the data analysis will not aware of the intervention. Therefore, the study will be run triple blinded.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-05-17, 1393/02/27
Ethics committee reference number
P/16/35/9/711

Health conditions studied

1

Description of health condition studied
Pain at surgical site at inguinal area
ICD-10 code
R10.3
ICD-10 code description
Pain localized to other parts of lower abdomen

Primary outcomes

1

Description
Pain at the surgical site
Timepoint
at 1, 6, 12, 18, 24, and 48 hours after surgery
Method of measurement
using VAS scale

2

Description
the amount of narcotic used
Timepoint
during the first 48 hours after surgery
Method of measurement
per mg

3

Description
the duration of time to receive narcotic
Timepoint
during the first 48 hours after surgery
Method of measurement
per min

Secondary outcomes

1

Description
vertigo
Timepoint
at 1, 6, 12, 18, 24, and 48 hours after surgery
Method of measurement
by question

2

Description
nausea and vomiting
Timepoint
at 1, 6, 12, 18, 24, and 48 hours after surgery
Method of measurement
by question

3

Description
pruritus
Timepoint
at 1, 6, 12, 18, 24, and 48 hours after surgery
Method of measurement
by question

Intervention groups

1

Description
34 patients will receive two gabapentin capsules 300 mg (600 mg) single dose 2 hours before surgery
Category
Treatment - Drugs

2

Description
34 patients will receive one gabapentin capsule 300 mg plus one placebo capsule (containing starch) single dose 2 hours before surgery
Category
Treatment - Drugs

3

Description
34 patients will receive two placebo capsules (containing starch) single dose 2 hours before surgery
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Beasat Hospital
Full name of responsible person
Dr Parisa Shirzad
Street address
Beasat Hospital, Shahed Square
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Beasat Hospital
Full name of responsible person
Dr Parisa Shirzad
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Beasat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 1341 6392
Fax
Email
shirzad.parisa7@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Beasat Hospital
Full name of responsible person
Dr Seyyed Mohammad Zolhavarieh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Beasat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 1341 6392
Fax
Email
dsmbszolhavarieh@yahoo.com
Web page address

Person responsible for updating data

Contact

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
Loading...