Protocol summary

Study aim
The effect of Gababentin preoperative administration to prevent or reduce pain following laparoscopy of advanced endometriosis
Design
Clinical trial with control and intervention group, three blind strains, phase 3 on 140 patients with 70 patients in each group
Settings and conduct
This study was performed in women with endometriosis referred to Hazrat Rasool Akram Hospital in 1300-1400. 70 patients with endometriosis will be in the gabapentin treatment group and 70 patients with endometriosis will be in the control group. Written consent to participate in the study is obtained. Then, in the treatment group, 600 mg of gabapentin with 30 cc of water is given one hour before the operation, and in the control group, placebo is given that have the same packaging and color. Patients All patients involved in this study, including surgeons and anesthesiologists and nurses, are not aware of the type of drug given to the patient. All patients undergo general anesthesia and laryngeal intubation. The operation time and operation technique are the same for all patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with endometriosis aged 16-40 years in Stage 3 and 4 diseases. Exclusion criteria: Kidney and liver patients, patients with gabapentin allergy, patients with mental disorders and epilepsy, as well as patients who have taken painkillers and any drugs and cigarettes one week before surgery
Intervention groups
70 patients with endometriosis will be in the gabapentin treatment group and 70 patients with endometriosis will be in the control group. Then, in the treatment group, 600 mg of gabapentin with 30 cc of water is given one hour before the operation, and in the control group, placebo is given that have the same packaging and color.
Main outcome variables
Reducing pain and reducing postoperative drug use using a single dose of gabapentin before surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150817023666N14
Registration date: 2021-04-21, 1400/02/01
Registration timing: prospective

Last update: 2021-04-21, 1400/02/01
Update count: 0
Registration date
2021-04-21, 1400/02/01
Registrant information
Name
Abolfazl Mehdizadeh kashi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 216651500
Email address
mehdizadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preoperative administration of gababentin to prevent or reduce pain following laparoscopy of advanced endometriosis
Public title
Evaluation of the effect of gabapentin in reducing pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Endometriosis patients aged 16-40 years in Stage 3 and 4 diseases
Exclusion criteria:
Kidney and liver patients patients with gabapentin allergy patients with mental disorders and epilepsy patients who have taken painkillers and any drugs and cigarettes one week before surgery
Age
From 16 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation in this study is limited to intervention and placebo groups using randomization. Random allocation law is the simplest and most limited method of randomization. This method represents a large block for the entire sample volume. For this purpose, the researchers first determined a total sample size, then randomly assigned a set of them to group A and the remainder to group B. For example in this study. A sample of 140 balls, 70 balls for intervention group A and 70 balls for intervention group B, was placed in a lottery container and then the balls were randomly removed from the container and replaced. This method is used for two or more group experiments.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study. The participant, the treating physician, the data collector, and the data analyzer are blind to the type of drug (drug and placebo). Randomization will be performed using a computer program. The codes are randomly selected for each participant. Each patient has a unique code. Based on the coding on the drug, the lead researcher will provide the drug to the participant.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Sattarkhan . Niayesh Street. Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Approval date
2021-03-03, 1399/12/13
Ethics committee reference number
IR.IUMS.REC.1399.1354

Health conditions studied

1

Description of health condition studied
Reduction of pain after laparoscopic endometriosis surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Reduction of pain and drug use after laparoscopic surgery
Timepoint
6, 12 and 24 hours after surgery
Method of measurement
Pain questionnaire based on Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, 600 mg of gabapentin with 30 cc of water is given to the patient one hour before the operation.
Category
Treatment - Drugs

2

Description
Control group: In the control group, an hour before the operation is given a placebo that has the same packaging and color
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Abolfazl Mehdizadeh Kashi
Street address
Sattar Khan. Niayesh Street. Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
mehdizadeh.a@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Abbas Motevalian-Vice President for Research of Iran University of Medical Sciences
Street address
Sattar Khan. Niayesh Street. Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
mehdizadeh.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abolfazl Mehdizadeh Kashi
Position
Professor of Laparoscopic Surgery
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sattar Khan. Niayesh Street. Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
mehdizadeh.a@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abolfazl Mehdizadeh Kashi
Position
Professor of Laparoscopic Surgery
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sattar Khan. Niayesh Street. Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
mehdizadeh.a@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abolfazl Mehdizadeh Kashi
Position
Professor of Laparoscopic Surgery
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sattar Khan. Niayesh Street. Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
mehdizadeh.a@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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