Protocol summary
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Study aim
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Determining the effect of adding low dose naloxone to remifentanil infusion on the postoperative pain of patients undergoing total hip replacement surgery.
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Design
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A randomized double-blinded clinical trial with Parallel groups, phase 2-3 on 80 patients
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Settings and conduct
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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 dose 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.
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Participants/Inclusion and exclusion criteria
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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.f
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Intervention groups
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The intervention considered the infusion of naloxone at the dose 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).
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Main outcome variables
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pain intensity
General information
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Reason for update
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Correction of typos recorded in the previous version
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220111053694N1
Registration date:
2022-08-07, 1401/05/16
Registration timing:
retrospective
Last update:
2023-10-10, 1402/07/18
Update count:
1
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Registration date
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2022-08-07, 1401/05/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-02-19, 1399/12/01
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Expected recruitment end date
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2022-03-16, 1400/12/25
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Actual recruitment start date
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2021-02-28, 1399/12/10
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Actual recruitment end date
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2022-04-25, 1401/02/05
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Trial completion date
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2022-05-23, 1401/03/02
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Scientific title
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Addition of a very low dose of naloxone to remifentanil infusion on postoperative pain in patients undergoing total hip replacement surgery
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Public title
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The effect of adding a very low dose of naloxone to remifentanil infusion on pain
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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)
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
80
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, patients and outcome assessors were unaware of the intervention and control groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-01-20, 1399/11/01
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1399.624
Health conditions studied
1
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Description of health condition studied
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Patients undergoing complete hip replacement surgery
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ICD-10 code
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Z96.6
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ICD-10 code description
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Presence of orthopaedic joint implants
Primary outcomes
1
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Description
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The patient's pain level
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Timepoint
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before the intervention and 4, 8, 12 and 24 hours after the intervention
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Method of measurement
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VAS scale (Based on this scale, a score between 1-10 is defined for the patient's pain)
Secondary outcomes
1
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Description
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Need to be sedated
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Timepoint
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The need for other painkillers after surgery to reduce the patient's pain
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Method of measurement
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Checklist
2
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Description
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Time to first sedative
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Timepoint
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after surgery
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Method of measurement
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Checklist based on the patient's needs and pain
3
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Description
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Cumulative dose of painkiller used
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Timepoint
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The first 24 hours after the surgery
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Method of measurement
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Checklist (total dose used)
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available