Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001652167
Ethics application status
Approved
Date submitted
25/06/2019
Date registered
26/11/2019
Date last updated
26/11/2019
Date data sharing statement initially provided
26/11/2019
Date results information initially provided
26/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
In the blood sample of the patients planned for nasal septoplasty was evaluated the level of opioid analgesic receptor and the relations between the level of receptor and pain score,
Scientific title
The relations between the level of Mu-opioid receptor (µORs) and postoperative analgesic use in patients undergoing septoplasty: a randomized, prospective trial.
Secondary ID [1] 298565 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patients undergoing septoplasty operation 313399 0
Condition category
Condition code
Anaesthesiology 311832 311832 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients were randomly selected to have into two groups. For postoperative analgesia, the first group (n=60) is patients using tramadol (1-2 mgr/ kg, intravenously) at the end of the surgery for postoperative analgesia. It is single dose. The second group is control group, and patients are initially given only fentanyl in the induction for analgesia. Fentanyl (1 µg/ kg, intravenously), propofol (2-3 mgr/ kg, intravenously), and muscle relaxant (rocuronium bromide 0,6 mgr/ kg, intravenously) are administered to all patients for induction as single dose. The medications were given intravenously to each group before awakened were performed by the Anesthesia Care Team.
All the patients’ vital signs were monitored during the operation.
We planned to audit of anesthesia nurse notes to assess or monitor fidelity to the intervention.
Intervention code [1] 315107 0
Early detection / Screening
Comparator / control treatment
The second group is control group in which initially performed only fentanyl (1 µg/ kg, intravenously) in the induction.
Control group
Active

Outcomes
Primary outcome [1] 320504 0
A continuous 10 cm visual analog scale (VAS) score was used to determine the level of postoperative pain. On the scale, 0 indicated ‘no pain’, and 10 indicated ‘severe pain’. The patients were asked to mark their pain at different times on the scale, and the results were calculated and recorded in millimeters.
Timepoint [1] 320504 0
Timepoints were the 1st (primary timepoint), 3rd, 7th and 10th hours in postoperative period.
Secondary outcome [1] 371831 0
needed second analgesic agent (Acetaminophen with codeine analgesic 325/ 30 mg. per-oral) timing and amount was recorded in postoperative period. We obtained this data from hospital nurse or physician records.
Timepoint [1] 371831 0
immediately in postoperative recovery room.

Eligibility
Key inclusion criteria
Patients undergoing septoplasty
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with surgical planning except septoplasty

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
ANOVA test (two ways classification with repeated measures) was used for statistical analysis of VAS values. P < 0.05 was accepted as statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/06/2015
Date of last participant enrolment
Anticipated
Actual
24/01/2019
Date of last data collection
Anticipated
Actual
28/01/2019
Sample size
Target
120
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 21629 0
Turkey
State/province [1] 21629 0
ISTANBUL

Funding & Sponsors
Funding source category [1] 303104 0
University
Name [1] 303104 0
BOZOK UNIVERSITY MEDICAL FACULTY
Country [1] 303104 0
Turkey
Primary sponsor type
Individual
Name
MUZAFFER GENCER
Address
Istinye University Medical Faculty, Bahçesehir Liv Hospital

Asik Veysel Mah, Süleyman Demirel Cd. No:1, 34517 Esenyurt/Istanbul
Country
Turkey
Secondary sponsor category [1] 303096 0
Individual
Name [1] 303096 0
AYSE YESIM GÖÇMEN
Address [1] 303096 0
Bozok University Medical Fcaulty
Department of Biochemistry

Çapanoglu Mah. Cemil Çiçek Cad Bozok Üniversitesi Erdogan Akdag Yerleskesi Atatürk Yolu 7. KM, 66100 Yozgat/ TURKEY
Country [1] 303096 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303649 0
The ethics committee of Bozok University Medical Faculty
Ethics committee address [1] 303649 0
Çapanoglu Mah. Cemil Çiçek Cad Bozok Üniversitesi Erdogan Akdag Yerleskesi Atatürk Yolu 7. KM, 66100 Yozgat/ TURKEY
Ethics committee country [1] 303649 0
Turkey
Date submitted for ethics approval [1] 303649 0
20/03/2015
Approval date [1] 303649 0
25/05/2015
Ethics approval number [1] 303649 0
25/ 12

Summary
Brief summary
we aimed to investigate whether there is a relationship between opioid receptor level and postoperative pain intensity
120 adult patients underwent septoplasty were randomly divided into preop 2 groups. The first group (n=60) was patients given tramadol (1-2 mgr/kg) for postop analgesia, and the second group (control group)(n=60) was initially performed only fentanyl (1 µg/ kg-i.v.) in the induction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94394 0
Dr MUZAFFER GENCER
Address 94394 0
Istinye University Medical Faculty, Bahcesehir Liv Hospital

Asik Veysel Mah, Süleyman Demirel Cd. No:1, 34517 Esenyurt/ ISTANBUL
Country 94394 0
Turkey
Phone 94394 0
+905059436459
Fax 94394 0
Email 94394 0
[email protected]
Contact person for public queries
Name 94395 0
Dr MUZAFFER GENCER
Address 94395 0
Istinye University Medical Faculty, Bahcesehir Liv Hospital

Asik Veysel Mah, Süleyman Demirel Cd. No:1, 34517 Esenyurt/ ISTANBUL
Country 94395 0
Turkey
Phone 94395 0
+905059436459
Fax 94395 0
Email 94395 0
[email protected]
Contact person for scientific queries
Name 94396 0
Dr MUZAFFER GENCER
Address 94396 0
Istinye University Medical Faculty, Bahcesehir Liv Hospital

Asik Veysel Mah, Süleyman Demirel Cd. No:1, 34517 Esenyurt/ ISTANBUL
Country 94396 0
Turkey
Phone 94396 0
+905059436459
Fax 94396 0
Email 94396 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
legal responsibility


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 377834-(Uploaded-25-07-2019-20-36-32)-Basic results summary.docx
Plain language summaryNo As the level of the µ-Opioid receptor (µORs) incre... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe relationship between the level of mu-opioid receptor (muORs) and postoperative analgesic use in patients undergoing septoplasty: A prospective randomized controlled trial.2020https://dx.doi.org/10.1186/s12871-020-01138-z
N.B. These documents automatically identified may not have been verified by the study sponsor.