Determining the difference between the effect of pregabalin and oral gabapentin as a prodrug in controlling pain after orthopedic surgery on the upper extremities.
Design
Clinical trial without control group, with parallel groups, double-blind, randomized, phase 2 on 120 patients, for randomization of Balance-block randomization with 4 permutations will be used.
Settings and conduct
The aim of this study was to compare postoperative pain in different parts of the upper extremities in patients receiving oral pregabalin and oral gabapentin as prodrug in Imam Khomeini Hospital in Ilam. A random preoperative case will be given to a group of patients at the right time and at the right dose, and the amount of postoperative pain will be compared at several times using the VAS questionnaire. Evaluates whether the patient will be unaware of the type of medication received.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Elective orthopedic surgery on one of the upper limbs with general anesthesia in the age range of 55-20 years and ASA class one and two. Exclusion criteria: Dissatisfaction of patient or guardian to participate in the study, severe hemodynamic instability, neurological disease or mental disorders, pre-seizure existence, acute and chronic kidney disease despite hypersensitivity to pregabalin and gabapentin, alcohol abuse And drugs or experience chronic pain relief.
Intervention groups
For intervention in patients undergoing orthopedic surgery on the upper extremities, one of the two drugs pregabalin or gabapentin will be randomly prescribed and the analgesic effects of these two drugs will be compared.
Main outcome variables
Variables include: age; Gender; Body mass index; Place of surgery; Severity of pain after surgery; Drug consumption; Morphine intake
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211013052759N1
Registration date:2021-10-20, 1400/07/28
Registration timing:prospective
Last update:2021-10-20, 1400/07/28
Update count:0
Registration date
2021-10-20, 1400/07/28
Registrant information
Name
Rana Roshanfekr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 4260 8531
Email address
roshanfekrrana@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-01, 1400/08/10
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the oral Pregabalin and Gabapentin effects as a premedication in pain control after orthopedic surgery on the upper limb.
Public title
Comparison of the oral pregabalin and gabapentin effects as a premedication in pain control after orthopedic surgery on the upper limb.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having elective orthopedic surgery on one of the upper limbs with general anesthesia
Age range 20_55 years
ASA class one and two
Exclusion criteria:
Patient or guardian dissatisfaction with participation in the study, severe hemodynamic instability, neurological disease or mental disorders, patients with a history of seizures, acute and chronic kidney disease, patients with a history of pregabalin and gabapentin allergies, alcohol and drug abuse Or a history of chronic analgesia
Severe hemodynamic instability
Neurological disease or mental disorders
Patients with a history of seizures
Acute and chronic kidney disease
Patient with a history of pregabalin and gabapentin allergies
alcohol and drug abuse Or a history of chronic analgesia
Age
From 20 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning, the candidates for surgery will be determined based on the entry and exit criteria, and then Balance-block randomization with 4 permutations will be used for random allocation Blocks used include: PPGG PGPG PGGP GGPP GPGP GPPG
Where the letter P (pregabalin group) and the letter G (gabapentin group) will be. RAS (Research Analysis and Statistics) software will be used to generate random blocks and a random number table will be used to select each block. Hide created sequence To hide the created sequence, boxes will be installed that will be exactly the same and random codes will be written on them, and each code will indicate a type of drug, and the drug in the box will be exactly the same. The list of codes prepared for each drug will be determined by the research team.
Hide created sequence:
To hide the created sequence, boxes will be installed that will be exactly the same and random codes will be written on them, and each code will indicate a type of drug, and the drug in the box will be exactly the same. The list of codes prepared for each drug will be determined by the research team and the final list will be at the discretion of the lead researcher. This method will ensure that the doctor or nurse prescribing the medicine does not know the type of medicine.
Blinding (investigator's opinion)
Double blinded
Blinding description
Volunteer patients will be aware of the type of both drugs to participate in the study before receiving the drug, but will not be aware of which of the two drugs they will receive in order to blind patients. Also, the nurses who collect the data will not be aware of which of the two drugs the patient has received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ilam University of Medical Sciences
Street address
No. 201, Kavand dead end, Javad mosque alley, Safa st.
City
Brujerd
Province
Lorestan
Postal code
6913884343
Approval date
2021-10-09, 1400/07/17
Ethics committee reference number
IR.MEDILAM.REC.1400.129
Health conditions studied
1
Description of health condition studied
Comparison of the effect of gabapantin and oral pregabalin as a prodrug in controlling pain after orthopedic surgery on the upper limb in Imam Khomeini Hospital in Ilam.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score in vas questionnaire
Timepoint
Measurement of pain intensity after recovery and 6 and 12 hours after surgery
Method of measurement
Visual analogue scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
.Intervention group: 120 patients with random entry conditions will be divided into two groups: pregabalin and gabapentin, so that there will be 60 people in each group. For the pregabalin group (P) one 150gg capsule will be prescribed one hour before surgery and for the gabapentin group 300mg will be administered two hours before the start of surgery. Patients will be given standard monitoring (blood pressure, heart rate, pulse oximetry, cardiography) at the beginning of the operating room. Patients with intravenous route No. 18 will be given 500 ml of Ringer's serum.Midazolam 1mg / kg is injected into the patient as a prodrug and at a dose of 2 mg / kg propofol and 0.5 mg / kg atracurium will be used to induce anesthesia. Will be used and after reviewing the vital signs and the appropriate depth of anesthesia, the surgeon will be allowed to begin surgery. After surgery, patients are transferred to recovery and patients are evaluated at three times (exit from recovery by anesthesiologist and at 6 and 12 hours after surgery by a nurse who is not aware of the type of medication received) for pain severity using a questionnaire. The VAS standard will be performed. In case of pain in case of pain with VAS score higher than 3, morphine will be injected intravenously at a dose of 0.1 mg / kg. The dose will be recorded in the relevant questionnaire and will continue to monitor pulse oximetry to diagnose loss of consciousness or respiratory depression in these patients, and we will even prescribe supplemental oxygen if necessary. Patients will then be evaluated for postoperative pain and the average dose of morphine in the two groups receiving pregabalin and gabapentin. Also, this comparison in gender and age subgroups and body mass index will be important for us and will be examined.