Determining the effect of adding low dose naloxone to remifentanil infusion on the postoperative pain of patients undergoing total hip replacement surgery.
Design
A randomized double-blinded clinical trial with Parallel groups, phase 2-3 on 80 patients
Settings and conduct
Patients were admitted for total hip joint replacement in the operating room of Qaem and Imam Reza hospitals, in a double-blind method (The patients were unaware of the type of substance used (naloxone or remifentanil) and the evaluator of the study outcomes was also unaware of which outcome was related to the intervention or control group), Patients were divided into two groups, intervention group included: Naloxan infusion at a rate of 0.25 µg/kg/h to an amount that reduces the incidence of side effects caused by the use of remifentanil (dose 0.30 µg/kg/min) after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who undergo hip replacement surgery with general anesthesia, no chronic pain, age 18-65 years, physical status ASA I-II. Exclusion criteria: obesity (BMI ≥ 30 kg/m2), pregnancy, addiction to drugs and alcohol, use of any pain reliever in the last 24 hours, unusual bleeding, decrease or increase of blood pressure by more than 30% of the baseline value.
Intervention groups
The intervention considered the infusion of naloxone at the rate of 0.25 µg/kg/h to the patients, in an amount that reduces the incidence of side effects caused by the use of remifentanil (dose 0.30 µg/kg/min) in patients after surgery. And the control group received only remifentanil (dose 0.30 μg/kg/min).
Main outcome variables
pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220111053694N1
Registration date:2022-08-07, 1401/05/16
Registration timing:retrospective
Last update:2022-08-07, 1401/05/16
Update count:1
Registration date
2022-08-07, 1401/05/16
Registrant information
Name
Saeid Jamalie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3894 0696
Email address
jamaliehbs971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
2021-02-28, 1399/12/10
Actual recruitment end date
2022-04-25, 1401/02/05
Trial completion date
2022-05-23, 1401/03/02
Scientific title
Addition of a very low dose of naloxone to remifentanil infusion on postoperative pain in patients undergoing total hip replacement surgery
Public title
The effect of adding a very low dose of naloxone to remifentanil infusion on pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
In this study, clinical trial of patients undergoing hip replacement surgery under general anesthesia
no contraindications for general anesthesia
no chronic pain
between 18 and 65 years
with physical condition ASA I-II (scoring status Physical, American society of Anesthesiologists)
filled out a written informed consent form
Exclusion criteria:
Obesity (BMI ≥ 30 kg / m2 )
pregnancy (based on B hcg check)
dependence on drugs and alcohol
use of any painkillers in the last 24 hours
unusual bleeding
ischemic heart disease
History of seizures
decrease or increase in blood pressure by more than 30% of baseline
any surgical complications such as prosthetic fractures or enlargement of the surgery due to extensive fractures of the pelvis
Postoperative exclusion criteria include reoperation
Excessive bleeding
long-term ventilation (> 12 hours)
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this randomized clinical trial study, patients are randomly divided into groups with a ratio of 1:1 in two equal parts and using block randomization and sealed envelopes. allocation Concealment is done with a sealed envelope. The envelope method is that the envelopes will be prepared and printed by a member of the research team and random numbers with the help of Randomaize.com and placed inside the envelope. The lid of the envelopes will be closed and its contents will not be visible from the outside.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and outcome assessors were unaware of the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ahmedabad Blvd., Qaem Hospital, Department of Anesthesia
City
Mashhad
Province
Razavi Khorasan
Postal code
9178936683
Approval date
2021-01-20, 1399/11/01
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.624
Health conditions studied
1
Description of health condition studied
Patients undergoing complete hip replacement surgery
ICD-10 code
Z96.6
ICD-10 code description
Presence of orthopaedic joint implants
Primary outcomes
1
Description
The patient's pain level
Timepoint
before the intervention and 4, 8, 12 and 24 hours after the intervention
Method of measurement
VAS scale (Based on this scale, a score between 1-10 is defined for the patient's pain)
Secondary outcomes
1
Description
Need to be sedated
Timepoint
The need for other painkillers after surgery to reduce the patient's pain
Method of measurement
Checklist
2
Description
Time to first sedative
Timepoint
after surgery
Method of measurement
Checklist based on the patient's needs and pain
3
Description
Cumulative dose of painkiller used
Timepoint
The first 24 hours after the surgery
Method of measurement
Checklist (total dose used)
Intervention groups
1
Description
Intervention group: In the intervention group, naloxone (Caspian tamin pharmaceutical co) with a very low dose (0.05 μg/kg/h) was added to remifentanil (Exir pharmaceutical co) infusion (with a dose of 0.3 μg/kg/min) as IV and through a continuous injection pump until the end of the operation in Patients undergoing total hip replacement surgery. The treatment method is based on the effect of narcotics on peripheral and central µu receptors and the effect of naloxone agonists and antagonists on these receptors.
Category
Treatment - Drugs
2
Description
Control group: Only remifentanil (Exir pharmaceutical co) infusion at a dose of 0.3 μg/kg/min as IV and through a continuous injection pump until the end of the operation was prescribed for patients undergoing total hip replacement surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Qaem Hospital
Full name of responsible person
Mohsen Saber Moghadam Ranjbar
Street address
Ahmedabad Boulevard, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9178936683
Phone
+98 51 3841 7402
Email
dr.saeidjamalie@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Saber Moghadam Ranjbar
Street address
Azadi Square, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9178936683
Phone
+98 51 3858 3878
Email
dr.saeidjamalie@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Saeid Jamalie Bastami
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
50 Sayad St., No. 28
City
Mashhad
Province
Razavi Khorasan
Postal code
9197815861
Phone
+98 51 3884 4186
Email
dr.saeidjamalie98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeid Jamalie bastami
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
50 Sayad St., No. 28
City
Mashhad
Province
Razavi Khorasan
Postal code
9197815861
Phone
+98 51 3884 4186
Email
drr.saeidjamalie@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeid Jamalie Bastami
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
50 Sayad St., No. 28
City
Mashhad
Province
Razavi Khorasan
Postal code
9178936683
Phone
+98 51 3884 4186
Email
dr.saeidjamalie@gmail.com
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