General purpose:
Determining the effect of adding pethidine to marcaine on postoperative pain score with spinal anesthesia in patients who are candidates for abdominal surgery referred to Amirul Mominin Hospital in Tehran city in 1402-1403
Design
A clinical trial with a control group, with parallel groups, single-blind, randomized, phase 3 on 58 patients. online random number table was used for randomization.
Settings and conduct
This clinical trial study is conducted in Tehran and Amirul Mominin Hospital in 1403-1402. 29 samples in each group and a total of 58 samples are included in the study. Patients are divided into intervention and control groups by online random number table. Demographic information of patients is entered in the data collection form.
The study is a single-blinded study in which the participants are unaware of the allocation of the study groups so that the desired drugs are drawn and combined in the spinal syringe before the surgery so that neither the patient nor the surgeon knows the drug being used in spinal and all patients in 2 groups are given spinal anesthesia with a 26 gauge needle in the same conditions. In the control group only marcaine is injected in the amount of 3cc and in the intervention group pethidine is added to marcaine in the amount of 25mg, then in recovery and at 6, 12, and 24 hours after the operation, the pain score after the operation is measured based on the VAS pattern.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Electiveness of operation
2. Age 18-65 years
Exclusion criteria:
1. Anesthesia class above 3
2. History of allergy to pethidine and marcaine drugs
Intervention groups
In the control group, only 3cc of marcaine will be injected, and in the intervention group, 25mg pethidine will be added to the marcaine.
Main outcome variables
Pain score in recovery and 6, 12, 24 hours in two intervention and control groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231204060259N1
Registration date:2024-01-01, 1402/10/11
Registration timing:registered_while_recruiting
Last update:2024-01-01, 1402/10/11
Update count:0
Registration date
2024-01-01, 1402/10/11
Registrant information
Name
Sina Moghadasian Naeini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2611 4678
Email address
sinamoghadasian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-03, 1402/09/12
Expected recruitment end date
2024-12-02, 1403/09/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of adding pethidine to Marcaine on the Score of postoperative pain with spinal anesthesia in candidates for abdominal surgery
Public title
Investigating the effect of adding pethidine to Marcaine on postoperative pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Electiveness of surgery
ASA1,2
Age 18-65 years
Signing a personal consent form to enter the study
No use of drugs and alcohol
Exclusion criteria:
Emergency patients
Anesthesia class above 3
History of allergy to marcaine and pethidine drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in the simple method (randomization based on a single sequence of random assignments). The randomization unit is individual. The randomization tool is an online random number table, so that from right to left, even numbers are considered for the intervention group and odd numbers are considered for the control group. To perform allocation concealment, each of the generated random sequences is written on a card, and the cards are placed in opaque, sealed and completely identical envelopes in order. To maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box respectively. At the time of registration of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. Patients are divided into two groups, 29 samples in each group and a total of 58 samples are included in the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
The drugs (which in the intervention group include marcaine and pethidine and in the control group only include marcaine) are drawn and combined in the spinal syringe before the surgery so that neither the patient nor the surgeon knows about the drug used in the spinal. Then, after the patients enter the operating room, all the patients in the same conditions in 2 groups get spinal anesthesia with a 26 needle.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The research ethics committee of medical school - Islamic Azad University of Medical Sciences, Tehra
Street address
13th floor, Block A, Treatment and Medical Education, Central Headquarters of the Ministry of Health, Simai Iran Street, between South Flamek and Zarafshan, Quds town (West)
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2023-11-27, 1402/09/06
Ethics committee reference number
IR.IAU.TMU.REC.1402.216
Health conditions studied
1
Description of health condition studied
pain score
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Postoperative pain score
Timepoint
Measurement of pain score in recovery, 6, 12, 24 hours in two intervention and control groups
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 25 mg of pethidine (Aburaihan pharmaceutical Co) is added to marcaine (Pharmed company) in the amount of 3 cc.
Category
Rehabilitation
2
Description
Control group: Only Marcaine (Pharmed company) is injected in the amount of 3cc.