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Trial registered on ANZCTR


Registration number
ACTRN12618001893291
Ethics application status
Approved
Date submitted
14/11/2018
Date registered
21/11/2018
Date last updated
21/11/2018
Date data sharing statement initially provided
21/11/2018
Date results provided
21/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Analgesia assessment by intermittent application and patient controlled pump after lumbar discectomy with Short Form McGill Questionnaire results that conclude patient controlled pump analgesia significantly contributes to the alleviation of postoperative pain.
Scientific title
Analgesia assessment by intermittent application and patient controlled pump after lumbar discectomy with Short Form McGill Questionnaire results that conclude patient controlled pump analgesia significantly contributes to the alleviation of postoperative pain.
Secondary ID [1] 296570 0
Nil known.
Universal Trial Number (UTN)
U1111-1223-7169
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain after lumbar discectomy 310361 0
Condition category
Condition code
Surgery 309092 309092 0 0
Surgical techniques
Anaesthesiology 309171 309171 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This prospective clinical study was conducted with the participation of 200 patients who underwent elective lumbar discectomy of the intervertebral disc extrusion at level LIV – LV. After being hospitalised for lumbar discectomy, patients were introduced to the possibility of participating in the study. Patients who agreed of their own free will, based on full awareness on the research being carried out, gave their informed consent.
Patients who used PCA pump were given verbal instructions, as well as written materials accompanied by skills and knowledge demonstration. Anaesthesiologist and a nurse with MNS degree, conducted this education. For the purpose of detailed comparison in regard to the success of different methods of analgesia administration, two analgesics are used in the research (derivate of opioid (INN) tramadol, and non-opioid (INN) paracetamol). Both analgesics were administered intermittently and by PCA pump, with schematics of daily intravenous application on the zero, first and second postoperative day.

Schematics of daily tramadol application on the zero, first and second postoperative day by PCA pump:
Drug concentrate: 12 mg/ml
Dilution volume: 50 ml
Dose unit: mg/h
Soft limit (limit that can be crossed, but the device warns of high dose, recommended drug dose): 600 mg/ 24 h
Device type (Infusomat/ Perfusor): Perfusor
Time period for the dose: 24 h
Set limits for the dose: 600 mg
Bolus quantity (bolus which a patient can administer in a specific time period): 20 mg
Lock time (time interval after which a patient can reapply bolus): 120 minutes
Initial bolus (therapy starts with bolus): 20 mg
Basal flow (continued flow during therapy): 1.38 ml/h

Schematics of daily paracetamol application on the zero, first and second postoperative day by PCA pump:
Drug concentrate: 10 mg/ml
Dilution volume: 600 ml
Dose unit: mg/h
Soft limit (limit that can be crossed, but the device warns of high dose, recommended drug dose): 6000 mg/ 24 h
Device type (Infusomat/ Perfusor): Infusomat
Time period for the dose: 24 h
Set limits for the dose: 6000 mg
Bolus quantity (bolus which a patient can administer in a specific time period): 166 mg
Lock time (time interval after which a patient can reapply bolus): 120 minutes
Initial bolus (therapy starts with bolus): 166 mg
Basal flow (continued flow during therapy): 16.6 ml/h

Schematics of daily intermittent tramadol application on the zero, first and second postoperative day:
0 hours: 150 mg
6 hours: 150 mg
12 hours: 150 mg
18 hours: 150 mg


Schematics of daily intermittent paracetamol application on the zero, first and second postoperative day:
0 hours: 1500 mg
6 hours: 1500 mg
12 hours: 1500 mg
18 hours: 1500 mg

Pain was assessed in equal time intervals (7 PM, 7 AM, 7 PM, 7 AM, 7 PM) on the zero, first and second postoperative day) using short form of the McGill pain questionnaire (SF-MPQ) in the Croatian language.
Intervention code [1] 312878 0
Treatment: Drugs
Intervention code [2] 312879 0
Treatment: Devices
Comparator / control treatment
Intermittent analgesia group.
Control group
Active

Outcomes
Primary outcome [1] 308078 0
Pain assessment using Short Form of the McGill pain questionnaire (SF-MPQ) on the zero postoperative day.
Timepoint [1] 308078 0
Pain was assessed in 7 PM on the zero postoperative day using Short Form of the McGill pain questionnaire (SF-MPQ) in the Croatian language.
Secondary outcome [1] 353889 0
Pain assessment using Short Form of the McGill pain questionnaire (SF-MPQ) on the first postoperative day.
Timepoint [1] 353889 0
Pain was assessed in 7 AM and 7 PM on the first postoperative day using Short Form of the McGill pain questionnaire (SF-MPQ) in the Croatian language.
Secondary outcome [2] 354134 0
Pain assessment using Short Form of the McGill pain questionnaire (SF-MPQ) on the second postoperative day.
Timepoint [2] 354134 0
Pain was assessed in 7 AM and 7 PM on the second postoperative day using Short Form of the McGill pain questionnaire (SF-MPQ) in the Croatian language.

Eligibility
Key inclusion criteria
The sample included 100 patients who underwent elective lumbar discectomy of intervertebral disc extrusion on level LIV – LV, diagnosed by magnetic resonance of the lumbosacral spine.
Inclusive criteria for participation in the study were age (over 18), first elective surgical procedure on level LIV - LV, no analgesic allergies, no malignant and liver diseases, mental capacity to give an informed consent and the ability to use a PCA pump.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria for participation in the research were age (under 18), emergency surgery, reoperation, known analgesic allergy, malignant disease, liver conditions, immunosuppressant therapy, mental incapacity for giving informed consent, inability to use PCA pump, difficulty communicating, drug addiction. The exclusion criteria during the research was the occurrence of side-effects of administered drugs.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group number and assignment to the group for each new participant was automated given by computer program when a new participant has given their consent to enter into the study. Since the trial investigators have no way of knowing which participant will go in which group, they have no influence on the randomisation. The database of participants and their allocation is independent and thus is not accessible to study personnel neither to patients except to receive a treatment assignment for a specific participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization was performed with the statistical program MedCalc for Windows, version 15.1 (www.medcalc.be).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative values were presented in arithmetic means, standard deviations, 95% confidence intervals (95% CI). Differences in categorical variables were analyzed on the X2 test, except in cases where there were less than 7 subjects per cell and where the Fisher-Freeman-Halton exact test was used.

One-way variant analysis (one-way ANOVA) analyzed the differences in the composite score (sum of all 15 questions of the SF-MPQ) between the examined groups, therapy administration methods and the type of administered analgesic. Differences between individual groups (4 groups tested) were further analyzed post hoc analysis with Scheffe correction. For each questionnaire, Cronbach coefficients of internal consistency were calculated for each questionnaire to confirm the appropriate structure of the obtained scale. All questionnaires had an acceptable Cronbach coefficient of internal consistency greater than 0.87.

The predicted values of pre-and post-operative of the SF-MPQ composite score values (LS estimated means) were analyzed by analyzing variance for repeated measurements with between-within interactions between the individual measurements and the investigated groups.

All P values less than 0.05 are considered to be significant. StatsDirect version 3.0.187 was used in the analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2016
Date of last participant enrolment
Anticipated
Actual
1/07/2017
Date of last data collection
Anticipated
Actual
5/07/2017
Sample size
Target
200
Accrual to date
Final
200
Recruitment outside Australia
Country [1] 21016 0
Croatia
State/province [1] 21016 0
Zagreb

Funding & Sponsors
Funding source category [1] 301149 0
Hospital
Name [1] 301149 0
Sestre milosrdnice University Hospital Center
Country [1] 301149 0
Croatia
Primary sponsor type
Individual
Name
Biljana Kurtovic
Address
University of applied health sciences
Mlinarska 38
10 000 Zagreb
Croatia
Europe
Country
Croatia
Secondary sponsor category [1] 300769 0
None
Name [1] 300769 0
There is none.
Address [1] 300769 0
There is none.
Country [1] 300769 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301897 0
Sestre milosrdnice University Hospital Centre Ethical Committee
Ethics committee address [1] 301897 0
Vinogradska 29,
10 000 Zagreb
Croatia, Europe
Ethics committee country [1] 301897 0
Croatia
Date submitted for ethics approval [1] 301897 0
01/03/2016
Approval date [1] 301897 0
24/03/2016
Ethics approval number [1] 301897 0
EP-4433/15-9

Summary
Brief summary
Low back pain is one of the leading cause of disability in an adult, working-active population representing a serious socioeconomic problem. Lumbar discectomy is the gold standard in symptomatic herniated disk treatment. Despite the advances in medicine, pharmacology and technology, postoperative pain frequency is still high. Hypothesis of this study was that opioid analgesia delivered by patient controlled pump is more effective in pain reduction compared to opioid intermittent analgesia and nonopioid analgesia after lumbar discectomy. The objectives were to determine the efficacy of two analgesics applied in different ways comparing the most effective method of analgesia. The study included 200 patients treated at the Department of Neurosurgery Sestre milosrdnice University Hospital Center, during 14 months period.
Trial website
There is none.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88474 0
Miss Biljana Kurtovic
Address 88474 0
University of applied health sciences
Mlinarska 38
10000 Zagreb
Croatia, Europe
Country 88474 0
Croatia
Phone 88474 0
00385981711722
Fax 88474 0
Email 88474 0
biljana.kurtovic@zvu.hr
Contact person for public queries
Name 88475 0
Biljana Kurtovic
Address 88475 0
University of applied health sciences
Mlinarska 38
10000 Zagreb
Croatia, Europe
Country 88475 0
Croatia
Phone 88475 0
00385981711722
Fax 88475 0
Email 88475 0
biljana.kurtovic@zvu.hr
Contact person for scientific queries
Name 88476 0
Biljana Kurtovic
Address 88476 0
University of applied health sciences
Mlinarska 38
10000 Zagreb
Croatia, Europe
Country 88476 0
Croatia
Phone 88476 0
00385981711722
Fax 88476 0
Email 88476 0
biljana.kurtovic@zvu.hr

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
215Ethical approval    376354-(Uploaded-12-11-2018-23-13-07)-Study-related document.JPG



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIntermittent tramadol vs tramadol administration via patient-controlled pump after lumbar discectomy: a randomized controlled trial.2022https://dx.doi.org/10.3325/cmj.2022.63.110
N.B. These documents automatically identified may not have been verified by the study sponsor.