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Trial registered on ANZCTR


Registration number
ACTRN12616000900415
Ethics application status
Approved
Date submitted
8/06/2016
Date registered
7/07/2016
Date last updated
16/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain treatment after open-chest operations with three possibilities of pain-relief therapy.
Scientific title
The assessment of various types of perioperative analgesia after the thoracotomy.
Secondary ID [1] 289390 0
None
Universal Trial Number (UTN)
U1111-1184-0054
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thoracotomy surgery 299052 0
Condition category
Condition code
Anaesthesiology 299091 299091 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients participated in the study will receive morphine in postoperative period. Pain will be measured with visual-analogue scale (VAS) during 24 hours after surgery as well as morphine consumption will be noted. Morphine will be administered with patient-controlled analgesia devices (PCA).
Each patient participated in the study will be aneasthetised in the same manner. Total intravenous anaesthesia approach: propofol, fentanyl, rocuronium. Other drugs (atropine, neostigmine, ondansetron) will be given as required.
30 minutes before the end of surgery, all patients will receive bolus of morphine ( 0.1-0,15 mg/kg) and 2 grams of metamizol intravenously.

In postoperative period each patient will get metamizol (every 6 h). When pain increases above 40 in VAS, patients will receive 5 mg of morphine. Ondansetron will be given as required due to nausea and vomiting.

Patients will be randomly assigned to one of the treated groups (i.e. contrainication to paravertebral catheter placement or allergy to any of drugs will exclude a patient from the study).
First group: before the surgery paravertebral catheter will be placed. Each patient in this group will receive 30 ml of local anaesthetic solution (0,25% bupivacaine with 2 mcg of fentanyl per ml) at the end of operation. After the emergence from general anaesthesia the infusion of local anesthetic solution will be continued (0.1 ml/kg/h) for 24 h.
Second group: after induction of general anaesthesia, but before the first incision, patients in this group will receive i.v. injection of ketamine (1 mg/kg)
Third group (control group): only morphine and metamizol will be given in postoperative period as pain-relief drugs (standard care).

1,2 and 6 months after the surgery neuropathic pain will be assesed. Each patient participated in the study will be called and NPSI (Neuropathic Pain Symptom Inventory)
will be used to measure pain.


Intervention code [1] 294979 0
Treatment: Drugs
Comparator / control treatment
Third group where intravenous morphine with patient control analgesia device (PCA) and metamizol will be given in postoperative period is treated as a comparator group.
Control group
Active

Outcomes
Primary outcome [1] 298559 0
Pain severity, assessed using 100mm visual analogue scale.
Timepoint [1] 298559 0
24 hours after the end of surgery
Secondary outcome [1] 324581 0
The secondary aim is evaluation of neuropathic pain 1, 3 and 6 months after surgery.
Neuropathic pain severity will be measured with Neuropathic Pain Symptom Inventory (NPSI)
Timepoint [1] 324581 0
1, 3 and 6 months after the thoracotomy

Eligibility
Key inclusion criteria
Elective thoracotomy surgery
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No consent obtained
Coagulopathy
Poorly-controlled diabetes mellitus
Depression or other psychiatric disorders which requiered antidepressant drugs
Alcohol or recreational drugs addiction

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)
randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
ANOVA will be used for continous data
logistic regression will be applied to assess neuropathic pain
Preliminary study was performed with 10 subjects in morphine and paravertebral groups to assess the statistical power (Statistica 12.5 was used). VAS means and SD were used. VAS in morphine and paravertebral group were respectively 59 and 40. 0.8 power with alfa 0.05 was achived for 40 patients (20 in each group).
Beacause only 2 groups were compared (3 in the study) and this quite good difference may have been achived by a chance, each studied group will doubled to 40 -50 patients.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7943 0
Poland
State/province [1] 7943 0

Funding & Sponsors
Funding source category [1] 293765 0
University
Name [1] 293765 0
Medical University of Lublin
Address [1] 293765 0
Medical University of Lublin
Al. Raclawickie 1
20-059
Lublin
Poland
Country [1] 293765 0
Poland
Primary sponsor type
University
Name
Medical University of Lublin
Address
Al. Raclawickie 1
20-059
Lublin
Poland
Country
Poland
Secondary sponsor category [1] 292595 0
None
Name [1] 292595 0
Address [1] 292595 0
Country [1] 292595 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295202 0
Komisja Bioetyczna przy Uniwersytecie Medycznym w Lublinie
Ethics committee address [1] 295202 0
Al. Raclawickie 1
20-059 Lublin
Poland
Ethics committee country [1] 295202 0
Poland
Date submitted for ethics approval [1] 295202 0
11/03/2016
Approval date [1] 295202 0
24/03/2016
Ethics approval number [1] 295202 0
KE-0254/84/2016

Summary
Brief summary
The main aim of the study is assessment of three types of analgesic approach in patients after thoracotomy. The secondary aim is evaluation of neurophatic pain 1, 3 and 6 months after surgery.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66506 0
A/Prof Michal Borys
Address 66506 0
First University Hospital of Lublin
ul. Staszica 16
20-081
Lublin
Poland
Country 66506 0
Poland
Phone 66506 0
+48815322713
Fax 66506 0
+48815322712
Email 66506 0
michalborys@umlub.pl
Contact person for public queries
Name 66507 0
A/Prof Michal Borys
Address 66507 0
First University Hospital of Lublin
The Second Department of Anesthesiology and Intensive Care
ul. Staszica 16
20-081
Lublin
Poland
Country 66507 0
Poland
Phone 66507 0
+48815322713
Fax 66507 0
+48815322712
Email 66507 0
michalborys@umlub.pl
Contact person for scientific queries
Name 66508 0
A/Prof Michal Borys
Address 66508 0
First University Hospital of Lublin
The Second Department of Anesthesiology and Intensive Care
ul. Staszica 16
20-081
Lublin
Poland
Country 66508 0
Poland
Phone 66508 0
+48815322713
Fax 66508 0
+48815322712
Email 66508 0
michalborys@umlub.pl

No information has been provided regarding IPD availability
Summary results
No Results