Protocol summary

Study aim
Comparison of the effect of postoperative pain control and complications of bupivacaine, tramadol and a mixture of bupivacaine and tramadol by injection at the incision site in patients undergoing elective cesarean section
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 90 patients by permutation block method was used for randomization by random allocation method.
Settings and conduct
Participants in the study (n = 90) will be assigned to 3 groups A, B and C by permutation block method. Patients and evaluators do not know the type of treatment groups of participating patients. Place of study: Imam Khomeini Hospital Anesthesia group
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 15-45 years, having informed written consent to cooperate with the study, patient classification in ASA1-2 class. Exclusion criteria: Refusal to continue cooperation in this study, adequate spinal anesthesia and its conversion to general anesthesia, allergy to any of the drugs used, history of addiction, underlying pain such as back pain, headache, history of psychiatric drugs, receiving Preoperative housing, history of addiction
Intervention groups
Group A, which is the control group, receives 10 mg of bupivacaine, which has reached a volume of 10 ml with normal saline, which is injected by the surgeon at the incision site at the end of the operation. Group B, which is the intervention group, receives 100 mg of tramadol, which has reached a volume of 10 ml with normal saline, and is finally injected by the surgeon at the incision site. Group C, which is the intervention group, receives 10 mg of bupivacaine and 100 mg of tramadol, which has reached a volume of 10 ml with normal saline, is finally injected by the surgeon at the incision site.
Main outcome variables
The degree of pain, itching. nausea and vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110306005993N3
Registration date: 2021-11-14, 1400/08/23
Registration timing: retrospective

Last update: 2021-11-14, 1400/08/23
Update count: 0
Registration date
2021-11-14, 1400/08/23
Registrant information
Name
Seyed Abdollah Emadi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1222 4340
Email address
aemadi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-19, 1400/05/28
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion of intraincisional bupivacaine, tramadol and bupivacaine plus tramadol in postoperative pain in elective cesarean section patients
Public title
Comparsion of intraincisional bupivacaine, tramadol and bupivacaine plus tramadol in postoperative pain in elective cesarean section patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 15-45 years Have informed written consent to cooperate with the study Patient classification in class ASA1,2
Exclusion criteria:
The patient refused to continue collaborating in this study Adequate spinal anesthesia and its conversion to general anesthesia Allergy to any of the drugs used History of addiction Existence of underlying pain such as back pain, headache History of using psychiatric drugs Get preoperative housing History of addiction
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to three groups through random blocking. A, B and C are 15 blocks of six randomly assigned blocking process and Random Allocation software is used. All 3 drugs are similar in appearance and volume and are responsible for preparing the mentioned drugs. Fill in syringes A, B and C and the anesthesia assistant injects the medicine into the patient according to the randomization block and random letters A, B and C without knowing the type of medicine. It is prepared in another room and delivered to the injector in the operating room.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs are prepared in a similar appearance and volume in another room and delivered to the injector in the operating room, where the patient injector and the evaluator are kept blind according to the type of treatment groups of the patients.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Imam Hospital of Sari - Research Ethics Committee of Mazandaran University of Medical Sciences
Street address
Amir Mazandaran Blvd. Imam Khomeini Educational and Medical Center
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Approval date
2021-08-11, 1400/05/20
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1400.024

Health conditions studied

1

Description of health condition studied
Cesarean section pain control
ICD-10 code
O82.1
ICD-10 code description
Delivery by emergency caesarean section

Primary outcomes

1

Description
The amount of pain
Timepoint
Intervals 6, 12 and 24 hours after surgery
Method of measurement
The Visual Analogue Scale (VAS) consists of a pain ruler that includes a horizontal line that is graded from zero to 10, with a 0-1 sign of pain 2-3 mild pain 4-6 moderate pain and 7 or more It is a sign of severe pain. In addition, it has various visual forms to determine the severity of pain.

Secondary outcomes

1

Description
Nausea and vomiting
Timepoint
Intervals of 6, 12 and 24 hours
Method of measurement
Yes-no based on patient observations and statements

Intervention groups

1

Description
Intervention group: The recipient of 100 mg of tramadol, which has reached a volume of 10 ml with normal saline, is finally injected by the surgeon at the incision site.
Category
Prevention

2

Description
Intervention group: The recipient receives 10 mg of bupivacaine and 100 mg of tramadol, which has reached 10 ml of normal saline, at the end of the operation by the surgeon at the incision site.
Category
Prevention

3

Description
Control group: Receiver of 10 mg of bupivacaine, which has reached a volume of 10 ml with normal saline, which is injected by the surgeon at the incision site at the end of the operation.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sari Anesthesiology Department
Full name of responsible person
Doctor SeyedAbdollah Emadi
Street address
Amir Mazandarani Blvd. Imam Khomeini Hospital Anesthesiology Department
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1700
Fax
+98 11 3336 3754
Email
aemadi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saedi
Street address
Moalem Ave
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3325 7230
Fax
+98 11 3325 7230
Email
m.saedi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Seyed Abdollah Emadi
Position
Assistant Professor, Faculty, Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani Blvd. Imam Khomeini Hospital Anesthesiology Department
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1700
Fax
+98 11 3336 3754
Email
aemadi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Seyed Abdollah Emadi
Position
Assistant Professor, Faculty, Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani Blvd. Imam Khomeini Hospital Anesthesiology Department
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1700
Fax
+98 11 3336 3754
Email
aemadi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hamid Qaderian
Position
Specialist Assistant in Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani Blvd. Imam Khomeini Hospital Anesthesiology Department
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1700
Fax
+98 11 3336 3754
Email
hamidghadirian@yahoo.com
Web page address
https://www.mazums.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
Loading...