Protocol summary

Summary
The aim of this randomized single-blind clinical trial is comparison of pilonidal sinus surgery complications between two methods of local and general anesthesia. A total of 60 patients, meeting eligibility criteria, will be randomly allocated into two equal groups. Local infiltration anesthesia group (n=30)received local anesthesia solution of 20ml:12ml lidocaine 2% , 1ml epinephrine 1/200000 , 6ml bupivacaine 0.5% , 50µg fentanyl (1ml); in sacrococcygeal region. General anesthesia for patients in the GA group will be used with intravenous midazolam 0.02ml/kg and fentanyl 3µg/kg as premedication and for induction from propofol 2mg/kg, atracuriom 0.5 ml/kg. During surgery, anesthesia will be maintained on need by isoflurane MAC 1, 60% nitrous oxide, fentanyl, atracurium and at the end of anesthesia residual Neuromuscular blockade was antagonized with neostigmine 0.05 mg / kg and atropine 0.15 mg/kg. The amount of intraoperative bleeding duration of surgery, operation time and at the recovery in moments of 1, 10, 20 and 30 min respiratory rates, nausea and vomiting, o2 saturation and blood pressure will be recorded.A nurse ( a blinded observer) will assess post-operative pain at 3, 6, 24, 48 and 72 with a visual analogue scale after surgery. The amount and type of analgesic drugs prescribed and the duration of hospitalization after surgery will be recorded at questionnaire. Patients one week and one month after surgery will visit by surgen assistant (A Blinded observer) to assess wound infection, wound seroma and recurrence after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201312031786N5
Registration date: 2014-05-15, 1393/02/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-15, 1393/02/25
Registrant information
Name
Nasrin Rahmani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 1700
Email address
nrahmani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pilonidal sinus surgery complications between two methods of local and general anesthesia
Public title
Pilonidal sinus surgery under local anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: informed written consent; ASA class Ι-ΙΙ. Exclusion criteria: recurrent and acute pilonidal sinus; substance abuse; cardiac disease; diabetes mellitus; sensitivity to local anesthetics; sever obesity (BMI>35).
Age
No age limit
Gender
Both
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)
Single 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 Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square.
City
Sari
Postal code
4817844718
Approval date
2013-03-06, 1391/12/16
Ethics committee reference number
91-203

Health conditions studied

1

Description of health condition studied
Pilonidal sinos
ICD-10 code
L05.9
ICD-10 code description
Pilonidal cyst without abscess

Primary outcomes

1

Description
The amount of intraoperative bleeding
Timepoint
At the end of operation
Method of measurement
Questionnaire

2

Description
The amount of intraoperative bleeding
Timepoint
At 3, 6, 24, 48 and 72 hours after surgery
Method of measurement
Visual Analog Scale

Secondary outcomes

1

Description
O2 saturation
Timepoint
At the recovery in minutes 1, 10, 20 and 30
Method of measurement
Questionnaire

2

Description
Operation time
Timepoint
At the end of operation
Method of measurement
Questionnaire

3

Description
Respiratory rate
Timepoint
At the recovery in minutes 1, 10, 20 and 30
Method of measurement
Questionnaire

4

Description
Blood pressure
Timepoint
At the recovery in minutes 1, 10, 20 and 30
Method of measurement
Questionnaire

5

Description
The amount and type of analgesic drugs prescribed
Timepoint
During hospitalization
Method of measurement
Questionnaire

6

Description
The duration of hospitalization
Timepoint
Hospitalization
Method of measurement
Questionnaire

7

Description
Wound infection
Timepoint
One week and one month after surgery
Method of measurement
Questionnaire

8

Description
Wound seroma
Timepoint
One week and one month after surgery
Method of measurement
Questionnaire

9

Description
Recurrence
Timepoint
One week and one month after surgery
Method of measurement
Questionnaire

Intervention groups

1

Description
Local infiltration anesthesia group(Interventional) 0n=30)received local anesthesia solution of 20ml:12ml lidocaine 2% , 1ml epinephrine 1/200000 , 6ml bupivacaine 0.5% , 50µg fentanyl (1ml); in sacrococcygeal region.
Category
Treatment - Drugs

2

Description
General anesthesia for patients in the GA group(Control) will be used with intravenous midazolam 0.02ml/kg and fentanyl 3µg/kg as premedication and for induction from propofol 2mg/kg, atracuriom 0.5 ml/kg.During surgery, anesthesia will be maintained on need by isoflurane MAC 1, 60% nitrous oxide, fentanyl, atracurium and at the end of anesthesia residual Neuromuscular blockade was antagonized with neostigmine 0.05 mg / kg and atropine 0.15 mg/kg.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam khomeni General Hospital
Full name of responsible person
Afshin Gholipour Baradari MD
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Mazandaran University of Medical Sciences, Moallem Square.
City
Sari
Grant name
10506
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Seyyed Mohamad Javad Heidari Yazdi
Position
Rezident of Surgery
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari
Postal code
4814839953
Phone
+98 15 1227 5038
Fax
+98 15 1226 3754
Email
javadheidari46@yahoo.com
Web page address
www.mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Nasrin Rahmani Boeeni MD
Position
Surgen, Assistant Professor
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari
Postal code
4814839953
Phone
+98 15 1227 5038
Fax
+98 15 1226 3754
Email
nrahmani@mazums.ic.ir drrahmani124@gmail.com
Web page address
www.mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abolfazl Firouzian MD
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari
Postal code
4814839953
Phone
+98 15 1227 5038
Fax
+98 15 1226 3754
Email
A.firouzian@mazums.ac.ir; Ab.firouzian@gmail.com
Web page address
www.mazums.ac.ir

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...