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Trial registered on ANZCTR


Registration number
ACTRN12614000658617
Ethics application status
Approved
Date submitted
8/06/2014
Date registered
24/06/2014
Date last updated
24/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of mean arterial pressure in continuous spinal anaesthesia versus ultrasound-guided combined psoas compartment-sciatic nerve block for hip replacement surgery in elderly high-risk patients: A prospective randomised study
Scientific title
Comparison of mean arterial pressure in continuous spinal anaesthesia versus ultrasound-guided combined psoas compartment-sciatic nerve block for hip replacement surgery in elderly high-risk patients: A prospective randomised study
Secondary ID [1] 284760 0
None
Universal Trial Number (UTN)
U1111-1157-7959
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anesthesia technique for hip replacement surgery in elderly high-risk patients 292131 0
Condition category
Condition code
Anaesthesiology 292464 292464 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Seventy patients over the age of 60 years with ASA (the classification of the American Society of Anaesthesiologists) III or IV physical status who underwent elective hip replacement surgery were included. Before participating in the study, the mental function and confusion states of patients were evaluated using Mini-Mental Status Examination (MMSE). Written informed consent was obtained from all participating patients. Patients were informed about the Visual analogue scales (VAS) before surgery. The age, weight and height of the patients, ASA physical status, preoperative electrocardiogram findings, mean arterial blood pressure (MBAP), heart rate (HR) and oxygen saturation values and the presence of additional disease such as hypertension (systolic/diastolic tension > 160/95 mmHg) and coronary artery disease were recorded. Thromboprophylaxis was provided using a low dose subcutaneous injection (40 mg) of low molecular weight heparin (Clexane'Registered Trademark', Aventis Intercontinental, France) 12 hours prior to surgery for all patients. Before transfer to the operating room, patients were assigned either to the CSA group (n = 35) or to the PCSNB group (n = 35) using a computer generated random number table. Ringer’s lactate solution was given intravenously at 1 to 2 mL/kg/hour via 18-gauge cannula in a forearm peripheral vein and standard monitoring included invasive arterial pressure, electrocardiography and pulse oximetry was established in the operating room. All patients in both groups were pre-medicated with intravenous (IV) midazolam (1 mg) before the procedure of anaesthesia. All anaesthesia procedures were performed by two experienced anaesthetists.
In the PCSNB group, psoas compartment block was performed using modified Winnie technique. After lateral decubitus position with the side to be operated uppermost and with the hip and knees flexed was provided for each patient, the skin over the lumbar paravertebral region was prepared by coating with sterile drapes. The 7 MHz ultrasound probe (Esaote, Firenze, Italy) was placed to the area (approximately 3-4 cm lateral and parallel to the lumbar spine). After the L3 spinous process was identified, the transverse process of L3 was located moving the probe horizontally. Then the local anaesthetic was infiltrated into the skin and an insulated stimulation needle (Stimuplex'Registered Trademark'––A Needle, 150 mm/20 G, Braun Medical, Melsungen, Germany) connected to a nerve stimulator (Stimuplex'Registered Trademark', HNS 11, Braun Medical, Melsungen, Germany) was introduced along the long axis of the ultrasound probe. A current strength for nerve stimulator was 0.5 to 0.8 mA at 1 Hz. The ultrasound guidance needle was slowly advanced under to the posterior part of the psoas muscle and the lumbar plexus was confirmed when ipsilateral quadriceps muscle contraction was observed. Following negative aspiration, the mixture of 30 mL local anaesthetic solution (10 mL 2% lidocaine + 1 mL 1:200.000 epinephrine + 19 mL 0.25% bupivacaine) was administered to the psoas compartment. The spread of local anaesthetic in the psoas compartment was demonstrated by ultrasound.After psoas compartment block was completed, the sciatic nerve block was applied according to the method described by Karmakar et al. The sciatic nerve was localised within the sub-gluteal space (the area between the hyper-echoic perimysium of the gluteus maximus and the quadratus femoris muscles). Then a needle with the same characteristics connected to a nerve stimulator delivering a current of 0.5 to 0.8 mA at a frequency of 1 Hz was inserted in the long axis of the ultrasound probe and advanced slowly towards the sciatic nerve. After foot plantar flexion indicating sciatic nerve stimulation was observed, 20 mL of the same anaesthetic solution was administered to the sciatic nerve following negative aspiration. The patient was then turned to the supine position and iliac crest block, with 5 mL of the same local anaesthetic solution was performed. In the CSA group, CSA was performed in the L3-L4 interspaced with the patient in lateral decubitus position with the side to be operated uppermost after cleaning and draping. The epidural space was identified with a Crawford needle and a 22-G (Spinocath'Registered Trademark', B. Braun, Melsungen, Germany) catheter with a 27-G Quincke spinal needle was advanced through the epidural space until cerebrospinal fluid was observed in the catheter. Then, the spinal catheter was advanced 2-4 cm into the intrathecal space and fixed using sterile tape. After the cerebrospinal fluid was aspirated, 2.5 mg isobaric 0.5% bupivacaine was injected manually while the patient was in a supine position.In both groups, the sensory block level was tested using pinprick tests and the motor block level was evaluated with the Modified Bromage scale (scale 0 = full flexion of foot, knee and hip, i.e. no motor block; scale 1 = full flexion of foot and knee, unable to hip flexion; scale 2 = full flexion of foot, unable to knee and hip flexion; scale 3 = total motor block; unable to foot, knee, and hip flexion) three times with an interval of 5 minutes. Sensory and motor block tests were performed bilaterally to evaluate possible epidural spread of the local anaesthetic. When sensory block (a loss of pin prick sensation) was not reached to the level of T12 within 10 minutes in the CSA group, additional 2.5 mg of isobaric bupivacaine 0.5% was administered through the catheter at 5-min intervals by limiting the total dose of 15 mg until a T12 level of the sensory block was achieved. When the satisfactory block level was provided, surgery was initiated in both groups. General anaesthesia protocol was administered for patients with three unsuccessful attempts to reach to spinal space in CSA group and for block procedure in PCSNB group. Also, if adequate surgical anaesthesia was not achieved after 30 minutes on patients of both groups, techniques were considered as failure and general anaesthesia protocol was administered for these patients. Continuing infusion of propofol at the speed of 10-50 microg/kg/min was planned for each patient with discomfort during operation. Patients required propofol infusion exceeding 50 microg/kg/min were considered to be unsuccessful blockade. Oxygen was delivered with a face mask and lactated Ringer's solution (5 mL/kg/h) was administered to all patients during surgery. Colloid solutions and paced red cells when necessary (haematocrit level < 30%) were used to treat perioperative blood loss. Patients' MABP, HR and oxygen saturation values were recorded at the beginning of anaesthesia procedure and surgery, every 5 minutes during surgery and at 1 hour after surgery by an observer who was blinded to study groups. Ephedrine (IV, 10-15 mg) was administered in the case of hypotension (a 30% decrease in systolic blood pressure compared with preoperative values) and atropine (IV, 0.5 mg) was applied when bradycardia (the heart rate < 45 beats/minute) was observed. Socio-demographic characteristics (age, body mass index, co-morbidities), the application time of anaesthetic technique (the time between the onset and end of anaesthesia procedure), duration of the block procedure (the time from the start of the anaesthetic procedure to the development of full motor block), duration of surgery (the time from the start of the surgical incision to the completion of surgery), highest sensory block level, the amount of intraoperative blood loss (weighing the sponges used during surgery plus the amount of blood in the suction bottle), anaesthetic complications and the number of patients required analgesics and sedatives during the block and surgical procedure were recorded. All surgical procedures were performed by the same three surgeons using the same surgical technique.After surgery, patients with intensive care requirements were transferred to the intensive care unit (ICU) and patients with stable clinical status were transferred to the orthopaedic ward. An anaesthesiologist blinded to group allocation visited the patients and postoperative side effects such as nausea, vomiting and bradycardia were recorded. Also, postoperative pain was evaluated at rest using a 10-cm VAS (0 cm = no pain; 10 cm = worst pain possible) and pain scores were recorded at 30 min and 1st, 2nd, 4th, 6th, 12th and 24th hours post-operatively.In the CSA group, morphine of 200 microg was administered through the subarachnoid catheter at the end of surgery for postoperative analgesia; the spinal catheter was removed two hours after completion of surgery. The presence of PDPH (increased pain intensity upon standing up from a supine position) was questioned in patients of the CSA group postoperatively. In the PCSNB group, morphine (0.1 mg/kg, subcutaneously) was administered to the patients at the end of surgery to provide postoperative analgesia. In the case of VAS > 3 in both groups, rescue analgesia was provided with IV tramadol 50 mg. The reversal time of the motor block and the number of patients required rescue analgesic in groups at first 24 hours postoperatively were recorded. On the postoperative first day, the MMSE was completed to detect the presence of postoperative confusion and the results were compared with the preoperative values.
Intervention code [1] 289553 0
Treatment: Drugs
Comparator / control treatment
Comparator group: In the CSA group, CSA was performed in the L3-L4 interspaced with the patient in lateral decubitus position using 5 mg of isobaric bupivacaine 0.5%. Intervention group: PCSNB group, ultrasound-guided psoas compartment block was performed with modified Winnie technique using 30 mL of anaesthetic solution solution (10 mL 2% lidocaine + 1 mL 1:200.000 epinephrine + 19 mL 0.25% bupivacaine) and iliac crest block was performed using the same local anaesthetic solution (5 mL). All patients in the PCSNB group needed continuing infusion of propofol (2 mg/kg/h) during operation.
Control group
Active

Outcomes
Primary outcome [1] 292326 0
The changes in mean arterial pressure values was assessed using a standard monitorization (Datex-Ohmeda, Helsinki, Finland).
Timepoint [1] 292326 0
before surgery, during surgery (the values in 5,10,20,30,90 th minutes), postoperative 1st hour
Secondary outcome [1] 308719 0
Heart rate values were assessed using a standard monitorization (Datex-Ohmeda, Helsinki, Finland).
Timepoint [1] 308719 0
before surgery, during surgery (the values in 5,10,20,30,90 th minutes), postoperative 1st hour
Secondary outcome [2] 308798 0
Peripheric oxygen saturation values were assessed using a pulse oximetry
Timepoint [2] 308798 0
before surgery, during surgery (the values in 5,10,20,30,90 th minutes), postoperative 1st hour
Secondary outcome [3] 308799 0
the application time of anaesthetic technique
Timepoint [3] 308799 0
the time between the onset and end of anaesthesia procedure
Secondary outcome [4] 308801 0
duration of the block procedure (the time from the start of the anaesthetic procedure to the development of full motor block). Complete motor block was defined as a Bromage score of 3.
Timepoint [4] 308801 0
the time from the start of the anaesthetic procedure to the development of full motor block
Secondary outcome [5] 308802 0
Highest sensory block level was assessed using Modified Bromage scale.
Timepoint [5] 308802 0
during surgery (the values in 5,10,20,30,90 th minutes).
Secondary outcome [6] 308803 0
the amount of intraoperative blood loss was assessed (weighing the sponges used during surgery plus the amount of blood in the suction bottle)
Timepoint [6] 308803 0
during surgery
Secondary outcome [7] 308804 0
the number of patients required analgesics and sedatives
Timepoint [7] 308804 0
during the block and surgical procedure
Secondary outcome [8] 308805 0
anaesthetic complications such as PDPH (increased pain intensity upon standing up from a supine position).
Timepoint [8] 308805 0
during surgery and postoperative postoperative period for up to 24 hours.

Eligibility
Key inclusion criteria
Over the age of 60 years with ASA (the classification of the American Society of Anaesthesiologists) III or IV physical status who underwent elective hip replacement surgery and Mini-Mental Status score > 5
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Mini-Mental Status score < 5, under the age of 60 and contraindications to anesthesia techniques

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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/efficacy
Statistical methods / analysis
With hemodynamic parameters as the primary outcome measurement, power calculation analysis revealed 31 patients in each study group to be necessary to find a difference of 20% in comparison with baseline MABP values with a power of 80%, a of 0.05 and Beta of 0.20. Data was analysed using SPSS software 12.0 (SPSS Inc., Chicago, IL, USA) and calculated as mean+/-standard deviation, P < 0.05 was considered significant. The Kolmogorov-Smirnov test was used to assess the normal distribution of data. If data were not normally distributed, comparisons were determined using Mann-Whitney U-test. Comparison of variables at different times between groups such as motor block were conducted using repeated measures two-way ANOVA test and Fisher’s exact test was used to compare the percentage values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2014
Actual
1/01/2014
Date of last participant enrolment
Anticipated
30/05/2014
Actual
30/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 6108 0
Turkey
State/province [1] 6108 0
Erzurum

Funding & Sponsors
Funding source category [1] 289377 0
Self funded/Unfunded
Name [1] 289377 0
Mehmet AKSOY
Country [1] 289377 0
Turkey
Primary sponsor type
Individual
Name
Mehmet AKSOY
Address
Dr. Mehmet AKSOY
Department of Anaesthesiology and Reanimation,
Faculty of Medicine, Ataturk University, Erzurum, Turkey
Postal code: 25240
Country
Turkey
Secondary sponsor category [1] 288062 0
None
Name [1] 288062 0
Address [1] 288062 0
Country [1] 288062 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291141 0
Ataturk University Medical Faculty Ethical Committee
Ethics committee address [1] 291141 0
Ethics committee country [1] 291141 0
Turkey
Date submitted for ethics approval [1] 291141 0
01/12/2013
Approval date [1] 291141 0
26/12/2013
Ethics approval number [1] 291141 0
13

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

Contacts
Principal investigator
Name 49074 0
Dr Mehmet AKSOY
Address 49074 0
Department of Anaesthesiology and Reanimation,
Faculty of Medicine, Ataturk University, Erzurum, Turkey
Postal code: 25240
Country 49074 0
Turkey
Phone 49074 0
+9 0442 3172295
Fax 49074 0
+9 0442 3172294
Email 49074 0
drmaksoy@hotmail.com
Contact person for public queries
Name 49075 0
Mehmet AKSOY
Address 49075 0
Department of Anaesthesiology and Reanimation,
Faculty of Medicine, Ataturk University, Erzurum, Turkey
Postal code: 25240
Country 49075 0
Turkey
Phone 49075 0
+9 0442 3172295
Fax 49075 0
+9 0442 3172294
Email 49075 0
drmaksoy@hotmail.com
Contact person for scientific queries
Name 49076 0
Ilker INCE
Address 49076 0
Department of Anaesthesiology and Reanimation,
Faculty of Medicine, Ataturk University, Erzurum, Turkey
Postal code: 25240
Country 49076 0
Turkey
Phone 49076 0
+9 0442 3172295
Fax 49076 0
+9 0442 3172294
Email 49076 0
ilkerince1983@yahoo.com

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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
SourceTitleYear of PublicationDOI
EmbaseContinuous spinal anaesthesia versus ultrasound-guided combined psoas compartment-sciatic nerve block for hip replacement surgery in elderly high-risk patients: A prospective randomised study.2014https://dx.doi.org/10.1186/1471-2253-14-99
N.B. These documents automatically identified may not have been verified by the study sponsor.