Protocol summary

Summary
The aim of this study is the assessment of intravenous sedation effect on surgery pain in hysteroscopic polypectomy compared with paracervical block. This is a randomized, not blinded, single-center study that is performed in Arash hospital, Tehran, Iran. Among women referred to Arash hospital laparoscopy clinic who have polyp less than 3 centimeter diameter based on ultrasonography and, are the candidate of hysteroscopic polypectomy are enrolled in the study. Inclusion criteria are patients aged between 18- 50 years old without history of cardiopulmonary diseases. Exclusion criteria are Lidocaine sensitivity and excess anxiety. After receiving informed consent, all patients are randomly divided into 3 groups of 28 members including: intravenous sedation; paracervical block and general anesthesia in intravenous sedation 1 micro grams/kg fentanyl and 0.1 mg/kg Midazolam is injected. Then 3 micro grams / kg Propofol is infused. In paracervical block 10 cc of 2% Lidocaine is injected in 4 and 8 o'clock of cevicovaginal mucous in Lithotomy position. In general anesthesia group, 1 micro grams/kg fentanyl and 0.1 mg/kg Midazolam is injected and consequently 100 micro grams / kg Propofol is infused. Then the surgery starts. In general anesthesia group, the amount of pain is asked in recovery room and 3 hours after surgery. In two other groups, the amount of pain is asked during inserting hysteroscope, polypectomy, curretaging, recover room and 3 hours after surgery. Pain is recorded based on visual analogue scale. The amount of pain, operation time and polyp 6 months recurrence is compared in all groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016031426855N3
Registration date: 2016-04-28, 1395/02/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-28, 1395/02/09
Registrant information
Name
Maryam Razavi
Name of organization / entity
Tehran university of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7771 9922
Email address
mrazavi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-04-18, 1395/01/30
Expected recruitment end date
2016-05-30, 1395/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of intravenous sedation effect on surgery pain in hysteroscopic polypectomy compared with paracervical block
Public title
Assessment of intravenous sedation effect on pain of surgical removing polyps compared with local anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients aged between 18- 50 years old with polyps less than 3 cm; no history of cardiopulmonary diseases. Exclusion criteria: Lidocaine sensitivity; excess anxiety.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
Qods Street, Keshavarz Bulevard
City
Tehran
Postal code
Approval date
2016-03-14, 1394/12/24
Ethics committee reference number
IR.TUMS.REC.1394.2225

Health conditions studied

1

Description of health condition studied
polypectomy
ICD-10 code
n84
ICD-10 code description
Polyp of corpus uteri

Primary outcomes

1

Description
The pain of surgery
Timepoint
During and 3 hours after surgery ( in general anesthetic group: only the pain of 3 hours after surgery)
Method of measurement
Visual analogue scale

Secondary outcomes

1

Description
Post operative recurrence of polyp
Timepoint
6 months after surgery
Method of measurement
Ultrasound

2

Description
Duration of operation
Timepoint
From anesthesia induction to discharge of recovery room
Method of measurement
Hour

3

Description
Complications of analgesia method
Timepoint
During analgesia, during surgery and 3 hours after surgery
Method of measurement
Check list

Intervention groups

1

Description
General anesthesia: 1 micro grams/ kg Fentanyl and 0.1 mg/kg Midazolam is injected and consequently 100 micro grams / kg Propofol is infused. Then the surgery starts.
Category
Treatment - Drugs

2

Description
In intravenous sedation: 1 micro grams/kg fentanyl and 0.1 mg/kg Midazolam is injected. Then 3 micro grams / kg Propofol is infused.
Category
Treatment - Drugs

3

Description
In paracervical block: 10 cc of 2% Lidocaine is injected in 4 and 8 o'clock of cevicovaginal mucous in Lithotomy position.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Women's Hospital
Full name of responsible person
Maryam Razavi
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences , Deputy of Research
Full name of responsible person
Dr. Masoud Younesian
Street address
Qods St, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences , Deputy of Research
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
Arash Women's Hospital,Tehran University of Medical Sciences
Full name of responsible person
Maryam Razavi
Position
Women specialist
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Avenue, Resalat High way
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
mrazavi@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arash Women 's Hospital, Tehran University of Medical Sciences,Tehran,Iran
Full name of responsible person
Zahra Asgari
Position
Associated professor
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
Dr.zahra.asgari@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arash Women hospital,Tehran University of Medical Science,
Full name of responsible person
Maryam Razavi
Position
Women specialist
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Avenue, Resalat High way
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
mrazavi@razi.tums.ac.ir
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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