Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001186741
Ethics application status
Approved
Date submitted
22/10/2013
Date registered
29/10/2013
Date last updated
29/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of two anesthesia methods in patients to undergo partial hip prosthesis
Scientific title
Comparison of unilateral spinal anesthesia and L1 paravertebral block combined with psoas compartment and sciatic nerve block in geriatric patients to undergo partial hip prosthesis in terms of hemodynamic effect and block quality.
Secondary ID [1] 283393 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Regional anesthesia,
partial hip prosthesis 290332 0
Condition category
Condition code
Anaesthesiology 290734 290734 0 0
Anaesthetics
Musculoskeletal 290759 290759 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients were randomly divided into two groups as spinal anesthesia group (Group SA)(n=25) and T12-L1 paravertebral block combined with psoas compartment block and sciatic nerve block group (Group PCSL)(n=25). All patients taken to the operation table were monitored by noninvasive arterial blood pressure, heart rate (HR), and peripheral oxygen saturation (SpO2). Before performing the block, peripheral vascular access was provided by 18G cannula on patients and 500 mL 0.9% NaCl solution was infused in 20 minutes. Hemodynamic parameters were recorded in 5-minute intervals till the end of preoperative and peroperative operation times. Patients in each group were administered 50microgr fentanyl IV before the procedure. Patients into Group SA were administered 2mL hyperbaric bupivacaine hydrochloride (Marcain Heavy 0.5%, Astra Zeneca ) with 25G Quincke spinal needle (Braun) from the selected intervertebral distance (L4-L5 or L3-L4) following local sterilization in lateral decubitus position. Following the procedure, patients left in this position for 15 minutes were positioned in lateral position so that the surgical side is on top. After observing dorsal and plantar flexion on feet with the help of a nerve stimulator (Multiplex, Pajunk, Germany) by using a 10cm-long block needle by Labat technique 7, sciatic nerve block was then obtained on patients in Group PCSL with 15mL bupivacaine hydrochloride (by mixing 5mg/mL Marcaine, AstraZeneca and 10mL 0.9% NaCl, making a total volume of 25mL) following negative aspiration technique. Then, when observed lumbar plexus stimulation (quadriceps muscle fasciculation) with the help of nerve stimulator by Winnie technique, psoas compartment block was obtained with 15mL bupivacaine hydrochloride (by mixing 5mg/mL Marcaine, AstraZeneca and 10mL 0.9% NaCl, making a total volume of 25mL) following negative aspiration technique. Later on, L1 paravertebral block was obtained with 5mL bupivacaine hydrochloride (by mixing 5mg/mL Marcaine, AstraZeneca and 5mL 0.9% NaCl, making a total volume of 10mL) by using the technique of Moore. Implementation time of both techniques, anesthesia preparation time, and the period until the beginning of surgical intervention were recorded as surgical preparation period. Level of analgesia was evaluated with pinprick test and motor block degree was assessed by modified Bromage scale (0: No block, 1: hip flexion blocked while knee is in extension, 2: Knee flexion blocked, 3: Complete motor block); following the administration of drug, sensory and motor block were evaluated with the measurement of hemodynamic parameters in 5-minute intervals. Sensory, motor and hemodynamic evaluations performed by an anesthesiologist who does not know which applied regional anesthesia techniques. After a complete motor block was developed, surgical intervention was initiated. The time from the beginning of surgical incision up to the completion of procedure was recorded as the operation time. A decrease of 25% and above in basal mean arterial pressure was accepted to be hypotension, and in that case, 5mg ephedrine IV and an additional 5mL/kg crystalloid fluid were administered. Heart rate reduced to 50/min was accepted as bradycardia and 0.5mg atropine IV was administered. The entire patients were given 3L/min O2 with mask and 5mL/kg/hour maintenance crystalloid fluid at the time of operation. Motor block return time and initial time of the need for analgesia were recorded.
Intervention code [1] 288143 0
Treatment: Drugs
Intervention code [2] 288172 0
Treatment: Surgery
Comparator / control treatment
Group SA is control group.
Control group
Active

Outcomes
Primary outcome [1] 290732 0
anesthesia preparation time (from monitorized to beginning surgical procedure)
Timepoint [1] 290732 0
at anesthesia induction
Primary outcome [2] 290739 0
Level of analgesia was evaluated with pinprick test
Timepoint [2] 290739 0
in 5-minute intervals following drug administration until appropriate sensorial levels was reached.
Primary outcome [3] 290740 0
motor block degree was assessed by modified Bromage scale (0: No block, 1: hip flexion blocked while knee is in extension, 2: Knee flexion blocked, 3: Complete motor block)
Timepoint [3] 290740 0
in 5-minute intervals following drug administration until a Bromage score of 2 or 3 (Complete motor block) was reached.
Secondary outcome [1] 305110 0
heart rate via electrocardigraphy
Timepoint [1] 305110 0
5-minute intervals from preoperative till the end of peroperative operation times
Secondary outcome [2] 305135 0
mean arterial pressure via noninvasive blood pressure measure (ossilometric)
Timepoint [2] 305135 0
5-minute intervals from preoperative till the end of peroperative operation times
Secondary outcome [3] 305136 0
peripheral oxygen saturation via pulse oximetry.
Timepoint [3] 305136 0
5-minute intervals from preoperative till the end of peroperative operation times
Secondary outcome [4] 305178 0
analgesic comsumption
Timepoint [4] 305178 0
24th hours postoperatively.

Eligibility
Key inclusion criteria
planned to be operated by RA method and to undergo partial hip prosthesis
ASA III-IV
Minimum age
68 Years
Maximum age
98 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that were allergic to local anesthesia, with neurological diseases, infection in the intervention area, with whom cooperation could not be established, and that did not accept the procedure were excluded from the study.

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)
closed envelope method
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/04/2012
Actual
25/04/2012
Date of last participant enrolment
Anticipated
22/02/2013
Actual
22/02/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5531 0
Turkey
State/province [1] 5531 0
Elazig

Funding & Sponsors
Funding source category [1] 288155 0
Self funded/Unfunded
Name [1] 288155 0
unfunded
Country [1] 288155 0
Primary sponsor type
Individual
Name
Ayse Belin OZER
Address
Deparment of Anesthesiology and Reanimation
Firat University Medical School
23119, Elazig
Country
Turkey
Secondary sponsor category [1] 286877 0
None
Name [1] 286877 0
Address [1] 286877 0
Country [1] 286877 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290071 0
Firat University Medical School Ethical Evaluation Commission Chairman
Ethics committee address [1] 290071 0
Ethics committee country [1] 290071 0
Turkey
Date submitted for ethics approval [1] 290071 0
29/03/2012
Approval date [1] 290071 0
19/04/2012
Ethics approval number [1] 290071 0

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

Contacts
Principal investigator
Name 43646 0
Dr Ayse Belin OZER
Address 43646 0
Department of Anesthesiology and Reanimation
Firat University Medical School
23119,Elazig
Country 43646 0
Turkey
Phone 43646 0
+90-424-2333555/2069
Fax 43646 0
Email 43646 0
[email protected]
Contact person for public queries
Name 43647 0
Ayse Belin OZER
Address 43647 0
Department of Anesthesiology and Reanimation
Firat University Medical School
23119,Elazig
Country 43647 0
Turkey
Phone 43647 0
+90-424-2333555/2069
Fax 43647 0
Email 43647 0
[email protected]
Contact person for scientific queries
Name 43648 0
Ayse Belin OZER
Address 43648 0
Department of Anesthesiology and Reanimation
Firat University Medical School
23119,Elazig
Country 43648 0
Turkey
Phone 43648 0
+90-424-2333555/2069
Fax 43648 0
Email 43648 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.