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Trial registered on ANZCTR


Registration number
ACTRN12614000371695
Ethics application status
Approved
Date submitted
1/04/2014
Date registered
8/04/2014
Date last updated
8/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Segmental Epidural Anaesthesia for Percutaneous Kyphoplasty
Scientific title
Segmental Epidural Anaesthesia and Its Effect on Postoperative Analgesic Requirement in Adult Patients Undergoing Elective Percutaneous Kyphoplasty Operation.
Secondary ID [1] 284372 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Segmental epidural anaesthesia in patients undergoing percutaneous kyphoplasty 291540 0
Condition category
Condition code
Anaesthesiology 291916 291916 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After obtaining local research ethical committee approval, fifty two ASA class I to III patients aged over 18 years scheduled for percutaneous kyphoplasty were recruited to the study. Severe systemic disease includes ASA class IV or more, pathology in cervical vertebra, known allergy to the study drugs, any contraindication for performing the epidural anaesthesia (bleeding diathesis, anticoagulation, hypovolemia, infection at the site of injection, increased intracranial pressure, severe aortic stenosis, severe mitral stenosis), presence of pregnancy, and cognitive disorders that preventing the cooperation were accepted as exclusion criteria. Patients requiring more than one level of intervention were excluded, also. Written informed consent was taken from the patients. Vascular access was found on the dorsum of the hand and crystalloid fluid infusion was started at a rate of 6 ml/kg/hour. Midazolam 1-1.5 mg was given intravenously as premedication. Patients were monitored for standard electrocardiography (ECG), blood pressure non invasively and peripheral oxygen saturation (SpO2) in the operating room. The patients were randomly allocated, using sealed envelopes, to one of the following 2 groups: 1. Group 1 (Group Epidural, n=26): Patients were placed in sitting position. After skin preparation, local anaesthesia was performed with 2 ml of lidocaine 2%. Segmental epidural anaesthesia was performed using loss of resistance technique with saline. Tuohy needle was introduced into the intervertebral space one segment lower than that of affected one. Aperture of the needle was directed to cranial and 0.5 % concentration of levobupivacaine of 1.25 ml per segment for thoracal and 1.5 ml per segment for lumbar approach was administered. Patients were placed in prone position. Analgesia of the surgical area was assessed using pinprick test. Operation was allowed when adequate analgesia was determined with pinpricks on at least two upper and two lower dermatomal levels of intervention, and it required approximately 15 minutes. Sedation was performed with midazolam 1-1.5 mg intravenously and fentanyl was given as 25 micro.g bolus doses if supplemental analgesia was necessary especially during trocar insertion. In the case of insufficient skin analgesia, general anaesthesia would be performed and the patient would be excluded from the study. 2. Group 2 (Group Control, n=26): General anaesthesia was performed in this group. After preoxygenation, propofol 2 mg/kg and rocuronium bromide 0.6 mg/kg was given for the induction. Endotracheal intubation was applied and anaesthesia was maintained with end tidal 2-2.5% concentration of sevoflurane in nitrous oxide-oxygen mixture (FiO2= 35%). Patients were ventilated with volume-controlled ventilation (Drager Primus, Lubeck, Germany). The respiratory rate was set to maintain an end-tidalCO2 between 4-4.5 kPa. After completation of the surgery, inhalation anaesthesia was discontinued. If adequate spontan ventilation (more than 6 mL/kg) was achieved, endotracheal tube was removed. Patients were observed until cooperation was achieved and then transferred to the post anaesthetic care unit (PACU). Haemodynamic parameters were recorded every 5 minutes during intraoperative and postoperative period. Patients were transferred to the ward when Modified Aldrete Score was greater than or equal to 9. Pain was assessed by an investigator who was blinded to the study groups at hourly intervals during postoperative 4 hours, and postoperative 24. hour. Pain was assessed by using a standard two sided plastic millimetric scale, ranging from 0 mm:no pain to 100 mm: worst pain imaginable. When VAS (visual analog scale) pain scores exceed 30 mm, dexketoprofen tromethamole 50 mg was infused and paracetamol 1 g was given intravenously when the VAS score was persistently higher than 30 mm in the following visit. If these treatments were inefficient, tramadol hydroclorur 25 mg was administered intravenously and repeated as required. Postoperative analgesic requirements, VAS scores, length of stay in PACU and complications were recorded.
Intervention code [1] 289103 0
Treatment: Other
Comparator / control treatment
In Group 2 (Group Control): Epidural anaesthesia was not applied. Standard general anaesthesia was performed .
Control group
Active

Outcomes
Primary outcome [1] 291826 0
The primary outcome of this study was to determine the difference in additional analgesic requirement ratio in the early postoperative period (4 hours) between groups. Patients who needed additional analgesic during postoperative 4 hours were recorded by an investigator who was blinded to the study groups. Ratio of the number of patients who needed additional analgesic was noted in each group when performing data analysis.
Timepoint [1] 291826 0
Analgesic requirement was noted at 1., 2., 3. and 4. postoperative hours.
Secondary outcome [1] 307626 0
Postoperative VAS scores. Pain was assessed by an investigator who was blinded to the study groups at hourly intervals during postoperative 4 hours, and postoperative 24. hour. Pain was assessed by using a standard two sided plastic millimetric scale, ranging from 0 mm:no pain to 100 mm: worst pain imaginable.
Timepoint [1] 307626 0
VAS measurement were recorded at 1., 2., 3., 4. and 24. postoperative hours.
Secondary outcome [2] 307692 0
Length of stay in PACU. The time between arrival in PACU and completion of the Modified Aldrete Score greater than or equal to 9 was recorded by an investigator .
Timepoint [2] 307692 0
The time between arrival in PACU and completion of the Modified Aldrete Score greater than or equal to 9 was recorded as length of stay in PACU.

Eligibility
Key inclusion criteria
Fifty two ASA class I to III patients aged over 18 years scheduled for percutaneous kyphoplasty were recruited to the study.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe systemic disease includes ASA class IV and more, pathology in cervical vertebra, known allergy to the study drugs, any contraindication for performing the epidural anaesthesia (bleeding diathesis, anticoagulation, hypovolemia, infection at the site of injection, increased intracranial pressure, severe aortic stenosis, severe mitral stenosis), presence of pregnancy, and cognitive disorders that preventing the cooperation were accepted as exclusion criteria. Patients requiring more than one level of intervention were excluded, also.

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)
After obtaining written informed consent, the patients were randomly assigned to one of the two groups as the responsible anesthesiologist opened the next sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total sample size of 44 (22 per group) was required to detect at least 25% difference in additional analgesic requirement ratio between groups with a power of 90% at the 5% significance level. Sample size estimation was performed by using NCSS and PASS 2000 (Hintze J. 2001. NCSS and PASS. Number Cruncher Statistical Systems. Kaysville, Utah.) software. This study was designed to enroll 26 patients in each group to allow for potential dropout of subjects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2012
Actual
4/06/2012
Date of last participant enrolment
Anticipated
28/06/2013
Actual
25/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment outside Australia
Country [1] 5951 0
Turkey
State/province [1] 5951 0

Funding & Sponsors
Funding source category [1] 289014 0
Self funded/Unfunded
Name [1] 289014 0
Country [1] 289014 0
Primary sponsor type
Individual
Name
Alparslan APAN
Address
Giresun University Medical Faculty, Department of Anaesthesiology and Intensive Care Medicine, Nizamiye Yerleskesi, Orhan Yilmaz Cad. Mumcular Sokak No:1 Postal Code: 28200, Merkez, Giresun.
Country
Turkey
Secondary sponsor category [1] 287691 0
None
Name [1] 287691 0
Address [1] 287691 0
Country [1] 287691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290821 0
Kirikkale University Ethics Committee
Ethics committee address [1] 290821 0
Ethics committee country [1] 290821 0
Turkey
Date submitted for ethics approval [1] 290821 0
Approval date [1] 290821 0
10/05/2012
Ethics approval number [1] 290821 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47422 0
Prof Alparslan APAN
Address 47422 0
Giresun University Medical Faculty, Department of Anaesthesiology and Intensive Care Medicine, Nizamiye Yerleskesi, Orhan Yilmaz Cad. Mumcular Sokak No:1 Postal Code: 28200, Merkez, Giresun.
Country 47422 0
Turkey
Phone 47422 0
+90454 310 16 00
Fax 47422 0
+90454 310 16 96
Email 47422 0
[email protected]
Contact person for public queries
Name 47423 0
Alparslan APAN
Address 47423 0
Giresun University Medical Faculty, Department of Anaesthesiology and Intensive Care Medicine, Nizamiye Yerleskesi, Orhan Yilmaz Cad. Mumcular Sokak No:1 Postal Code: 28200, Merkez, Giresun.
Country 47423 0
Turkey
Phone 47423 0
+90454 310 16 00
Fax 47423 0
+90454 310 16 96
Email 47423 0
[email protected]
Contact person for scientific queries
Name 47424 0
Alparslan APAN
Address 47424 0
Giresun University Medical Faculty, Department of Anaesthesiology and Intensive Care Medicine, Nizamiye Yerleskesi, Orhan Yilmaz Cad. Mumcular Sokak No:1 Postal Code: 28200, Merkez, Giresun.
Country 47424 0
Turkey
Phone 47424 0
+90454 310 16 00
Fax 47424 0
+90454 310 16 96
Email 47424 0
[email protected]

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Results publications and other study-related documents

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