Protocol summary

Study aim
Comparison of analgesia after hemorrhoidectomy using local and intrasphincteric injection of bupivacaine
Design
This is a double-blind clinical trial study with parallel groups that is performed by simple randomization method with the help of STATA software on 60 patients referred for hemorrhoidectomy.
Settings and conduct
All patients referred to hospitals and private clinics for hemorrhoidectomy who met the inclusion and exclusion criteria were included in the study. After performing a similar anesthesia procedure, one group underwent local injection and the other group underwent intrasphincteric injection in 4 positions (12, 3, 6, and 9 o'clock). Finally, hemorrhoidectomy is performed. Finally, 6 and 12 hours after Patients' full recovery, the patient's need for analgesia, and pain intensity are assessed and compared using a Visual Analogue Scale for Pain that will be used for both groups. The patient and the person evaluating the pain are blind to the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria were people between the ages of 20 and 70 and those who were in Class I and II according to the ASA (anesthesia class) criteria, and the non-inclusion criteria were those who were in Class III and IV according to the ASA criteria. People with a history of drug addiction, people with a history of any heart, liver, kidney or neurological disease, or allergies to any medication, and inability to determine the use of a verbal scale.
Intervention groups
In patients referred for hemorrhoidectomy, bupivacaine injection is performed to reduce postoperative pain at the operation site by two methods, local and intrasphincteric, and finally Postoperative analgesia is compared.
Main outcome variables
Evaluation patients' pain after surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201031049201N1
Registration date: 2020-11-12, 1399/08/22
Registration timing: prospective

Last update: 2020-11-12, 1399/08/22
Update count: 0
Registration date
2020-11-12, 1399/08/22
Registrant information
Name
Seyed Sana Davoudi Moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5770
Email address
sana.davoudi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-15, 1399/08/25
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of post Operative analgesia with intraoperative administration of bupivacaine localy and intrersphincteric in hemorrhoidectomy operation
Public title
Comparison of the effect of anesthetic injection in two ways on pain in patients after hemorrhoidectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People between the ages of 20 and 70 People who met the ASA criteria (anesthesia class)in class I and II
Exclusion criteria:
People with a history of drug addiction People with a history of any heart, liver, kidney, neurological disease Allergies to any medication Inability to determine the use of verbal pain scale (such as people with mental disabilities) Dissatisfaction with participation in the study
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization is used and the unit is individual randomization. In this way, with the help of STATA software, random codes are assigned to each patient in both intervention groups about the injection method and are recorded on a questionnaire, and the patient and the questioner are blind to avoid bias towards those codes.
Blinding (investigator's opinion)
Double blinded
Blinding description
After obtaining the patient's informed consent, surgery is performed and the patient does not know about his anesthesia method during the operation. Also, after the operation and the patient entering the ward, the questioner does not know about the injection method and only completes the pain questionnaire.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan, Dr hesabi Square, Pardis of medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2020-01-05, 1398/10/15
Ethics committee reference number
IR.ZAUMS.REC.1399.318

Health conditions studied

1

Description of health condition studied
Hemorrhoid
ICD-10 code
K64.8
ICD-10 code description
Other hemorrhoids

Primary outcomes

1

Description
Pain status after hemorrhoidectomy in both groups
Timepoint
Evaluation of pain status in both groups 6 and 12 hours after surgery
Method of measurement
Visual Analogue Scale for patient that is measured by the patient from 0 to 10

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: All patients received 1 gram of antibiotic (keflin) before the operation and by the same method of general anesthesia, by receiving 5 cc per kg of preloaded fluid and then by injecting 1-2 micro grams per kilogram of fentanyl and 1-2 Mg per kg succinylcholine and 3-5 mg per kg Nestonal are anesthetized. Then, in the lithotomy position, one group underwent intra-sphincter injection of bupivacaine by Abu Reihan company in 4 positions (12, 3, 6, 9 and 9 o'clock).
Category
Prevention

2

Description
Intervention group: The second intervention group underwent local bupivacaine injection at the site of lithotomy with a similar anesthesia method.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Research Hospital
Full name of responsible person
Seyed Sana Davoudi Moghadam
Street address
Salamat Blvd, Persian Gulf highway, Imam Ali Research Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
public@zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Nasiruddin Tabatabai
Street address
Dr Hesabi Square, Pardis of medical science
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Seyed Sana Davoudi Moghadam
Position
Resident of surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
salamat Blvd, Khalij fars boulvard.Emam Ali Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5770
Fax
Email
sana.davoudi@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Seyed Sana Davoudi Moghadam
Position
Resident of surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
salamat Blvd, Khalij fars boulvard.Emam Ali Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5770
Fax
Email
sana.davoudi@zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Seyed Sana Davoudi Moghadam
Position
Resident of surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
salamat Blvd, Khalij fars boulvard.Emam Ali Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5770
Fax
Email
sana.davoudi@zaums.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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