<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03021421</url>
  </required_header>
  <id_info>
    <org_study_id>OrduU</org_study_id>
    <nct_id>NCT03021421</nct_id>
  </id_info>
  <brief_title>Comparison of Two Regional Technics In Knee Artroplasty</brief_title>
  <acronym>CTRTIKA</acronym>
  <official_title>The Effect of Unilateral Spinal Anaesthesia and Psoas Compartment With Sciatic Block on the Postoperative Pain Management in Total Knee Artroplastic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>T.C. ORDU ÜNİVERSİTESİ</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>T.C. ORDU ÜNİVERSİTESİ</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: This prospective, randomised, controlled, single-blind, multicentre study was&#xD;
      designed to investigate the effects of peripheral nerve block methods (applied using&#xD;
      unilateral spinal anaesthesia [USA] on elderly patients scheduled to undergo total knee&#xD;
      arthroplasty) on perioperative haemodynamic parameters and the postoperative analgesia&#xD;
      period.&#xD;
&#xD;
      Materials and Methods: Sixty patients in the American Society of Anesthesiologists (ASA)&#xD;
      Physical Status II-III group were randomly divided into two groups. Spinal anaesthesia was&#xD;
      performed in the USA group, in the lateral position through the intervertebral space, with 2&#xD;
      ml of hyperbaric bupivacaine (L4-L5 or L3-L4); 0.5% bupivacaine hydrochloride and 2%&#xD;
      lidocaine were combined for the psoas compartment-sciatic (PCS) group, and the mixture was&#xD;
      used for psoas compartment block (PCB) and sciatic nerve block. The haemodynamic parameters&#xD;
      were recorded every 5 minutes until the end of the preoperative and perioperative operation&#xD;
      periods and postoperative first analgesic application time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this prospective, randomised, multicentric and single-blind study, 60 patients who were&#xD;
      diagnosed with gonarthrosis in the outpatient clinic of Ordu University Training Hospital and&#xD;
      Ordu State Hospital between January 1, 2015 and June 30, 2015, and planned for total knee&#xD;
      arthroplasty, were included. Patients who were allergic to local anaesthetics, had&#xD;
      neurological disease, had infections in the intervention area, did not cooperate, or did not&#xD;
      agree to the intervention were excluded from the study. After receiving informed consent from&#xD;
      the patients, they were divided into two groups using the closed envelope method: the USA&#xD;
      Group was the spinal anaesthesia (SA) group (n = 30), and the PCS group was the PCB and&#xD;
      sciatic nerve block group (n = 30). All of the patients planned for surgery were monitored in&#xD;
      terms of non-invasive arterial blood pressure, heart rate (HR) and peripheral haemoglobin&#xD;
      oxygen saturation (SpO2). Peripheral vascular access was established using an 18-G cannula&#xD;
      before the block operation, and 500 ml of 0.9% NaCl solution was infused for 20 minutes&#xD;
      followed by the intravenous administration of 0.07 mg/kg midazolam (Dormicum®; Roche, Basel,&#xD;
      Switzerland). The haemodynamic parameters were recorded every 5 minutes until the end of the&#xD;
      preoperative and perioperative operation period. Next, 2 ml of hyperbaric bupivacaine&#xD;
      hydrochloride (Marcain Heavy 0.5%; AstraZeneca®, London, UK) was administered to patients in&#xD;
      the USA group in the lateral decubitus position, after regional sterilisation, through the&#xD;
      selected intervertebral space (L4-L5 or L3-L4) using a 25-G Quincke spinal injector (B.&#xD;
      Braun®, Melsungen, Germany). After remaining in this position for 15 minutes after the&#xD;
      procedure, the patients were changed to the supine position. Patients in the PCS group were&#xD;
      changed to the lateral decubitus (Simms) position. Following the sterilisation and covering&#xD;
      procedures required for blockade of the lumbar plexus somatic nerves, the abdominal settings&#xD;
      were selected on the ultrasound device (Mindray DC-T6 VET®, Shenzhen, China). The depth was&#xD;
      set at 11-12 cm, and the frequency was set at 4-8 MHz. A convex ultrasonography (USG) probe&#xD;
      was placed 4 cm laterally on the middle line at the L3-L5 level. The transverse process was&#xD;
      longitudinally identified using an USG probe. The 'trident sign' (three-pronged spear&#xD;
      appearance) acoustic shadow of the transverse process is characteristic. After viewing the&#xD;
      psoas muscle at the depth of the transverse process, the needle was inserted using an&#xD;
      out-plane approach. While using a nerve stimulator simultaneously (Stimupleks A; B. Braun®,&#xD;
      Melsungen AG, Germany), the stimulation current was reduced to the 0.5-1.0 mA level when&#xD;
      contraction of the quadriceps muscle was observed, and 20 ml of local anaesthetic (5 ml of 2%&#xD;
      lidocaine + 15 ml of 0.5% bupivacaine) was injected. The local anaesthetic was observed to&#xD;
      disperse around the lumbar plexus with USG. Sciatic nerve block was applied as follows: the&#xD;
      patients' positions were not changed, and the skin was disinfected in the same position&#xD;
      (lateral decubitus position). Following the required covering process, the USG settings were&#xD;
      applied for optimum visualisation. The depth was set as 3-6 cm, and frequency as 2-8 MHz. The&#xD;
      convex USG probe was placed in the subgluteal area in the transverse position. After&#xD;
      determining the sciatic nerve, the injector was inserted into the lateral edge of the probe&#xD;
      as in-plane and proceeded towards the nerve. When using the nerve stimulator simultaneously&#xD;
      (Stimupleks A; B. Braun®), the stimulation current was reduced to 0.2-0.5 mA until&#xD;
      contractions became visible. The local anaesthetic was observed to disperse around the&#xD;
      sciatic nerve with USG by administering 20 ml of local anaesthetic (5 ml of 2% lidocaine + 15&#xD;
      ml of 0.5% bupivacaine) following negative aspiration with the injector. The patients were&#xD;
      changed to the supine position. Surgery was allowed when effective sensory block reached with&#xD;
      at least a T10 dermatome.&#xD;
&#xD;
      After the procedure, the patients were changed to the supine position. The application times&#xD;
      of both techniques were recorded as the technique application times. While the analgesia&#xD;
      level was evaluated using the pinprick test, the degree of motor block was assessed using the&#xD;
      modified Bromage scale (0: no block, 1: hip flexion is blocked when the knee is extended, 2:&#xD;
      knee flexion is blocked, 3: full motor block). Additionally, the sensory and motor blocks&#xD;
      were evaluated at 5-minute intervals using the measurements of the haemodynamic parameters&#xD;
      after the administration of medications. No case was excluded from the study because of block&#xD;
      failure; thus, the data of all the cases in both groups were analysed.&#xD;
&#xD;
      Surgical intervention was initiated after the development of a full motor block. The time&#xD;
      from the beginning of surgical incision until the completion of the procedure was recorded as&#xD;
      the operation period. A decrease in the mean basal arterial pressure of 25% or more was&#xD;
      considered as hypotension; in this case, ephedrine was administered as 5 mg intravenously&#xD;
      (i.v.), and 5 ml/kg additional crystalloid fluid was given. Heart rates less than 50&#xD;
      beats/minute were considered as bradycardia, and atropine was administered as 0.5 mg i.v. All&#xD;
      of the patients were administered 3 l/minute O2 through the mask and 5 ml/kg/hour maintenance&#xD;
      crystalloid i.v. fluid during the surgery. The motor block return time and first analgesic&#xD;
      requirement time were recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative VAS values</measure>
    <time_frame>postoperative first 24 hour</time_frame>
    <description>Visual Analog Scale (mm)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perioperative Heart Rate</measure>
    <time_frame>perioperative 150 minute</time_frame>
    <description>Beat to beat variability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative Mean Arterial Pressure</measure>
    <time_frame>perioperative 150 minute</time_frame>
    <description>mmHg</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Postoperative Analgesia</condition>
  <condition>Anesthesia; Functional</condition>
  <arm_group>
    <arm_group_label>Group USA</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>(Marcain Heavy 0.5%; AstraZeneca®, London, UK) using a 25-G Quincke spinal injector (B. Braun®, Melsungen, Germany).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group PCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>(Stimupleks A; B. Braun®, Melsungen AG, Germany) to lumbar plexus in psoas muscle compartment (injected material 20 ml local anaesthetic mixture5 ml of 2% lidocaine + 15 ml of 0.5% bupivacaine)&#xD;
%2 Aritmal ampul (Osel İlaç,Turkey) and Marcaine %0.5 flacon (AstraZeneca®, London, UK)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>intratechal (subarachnoidal )injection</intervention_name>
    <description>10 mg (2 cc) intrathecal single shot injection</description>
    <arm_group_label>Group USA</arm_group_label>
    <other_name>Marcaine Spinal 0,5 % Heavy ampule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>lombar plexus and sciatic nerve injection</intervention_name>
    <description>USG -guided lumbar plexus visualised and 20 ml local anaesthetic mixture (15 cc %0,5 Bupivacaine Hydrochloride 5 cc and %2 Lidocaine 5 cc ) for lombar plexus single shot injection</description>
    <arm_group_label>Group PCS</arm_group_label>
    <other_name>Marcaine %0,5 20 cc flacon and Aritmal %2 ampule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 50-80 age patients who have gonarthrosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under 50 year&#xD;
&#xD;
          -  above 80 years&#xD;
&#xD;
          -  and who have local anaesthetic allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>February 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 12, 2017</last_update_submitted>
  <last_update_submitted_qc>January 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>T.C. ORDU ÜNİVERSİTESİ</investigator_affiliation>
    <investigator_full_name>Ebru Canakci</investigator_full_name>
    <investigator_title>M.D</investigator_title>
  </responsible_party>
  <keyword>Total knee arthroplasty</keyword>
  <keyword>unilateral spinal anaesthesia</keyword>
  <keyword>psoas compartment block</keyword>
  <keyword>sciatic nerve block</keyword>
  <keyword>haemodynamic effects</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03021421
org study id: OrduU
nct id: NCT03021421
lead sponsor: 
has dmc: Yes
Purpose: This prospective, randomised, controlled, single-blind, multicentre study was
      designed to investigate the effects of peripheral nerve block methods (applied using
      unilateral spinal anaesthesia [USA] on elderly patients scheduled to undergo total knee
      arthroplasty) on perioperative haemodynamic parameters and the postoperative analgesia
      period.

      Materials and Methods: Sixty patients in the American Society of Anesthesiologists (ASA)
      Physical Status II-III group were randomly divided into two groups. Spinal anaesthesia was
      performed in the USA group, in the lateral position through the intervertebral space, with 2
      ml of hyperbaric bupivacaine (L4-L5 or L3-L4); 0.5% bupivacaine hydrochloride and 2%
      lidocaine were combined for the psoas compartment-sciatic (PCS) group, and the mixture was
      used for psoas compartment block (PCB) and sciatic nerve block. The haemodynamic parameters
      were recorded every 5 minutes until the end of the preoperative and perioperative operation
      periods and postoperative first analgesic application time.
In this prospective, randomised, multicentric and single-blind study, 60 patients who were
      diagnosed with gonarthrosis in the outpatient clinic of Ordu University Training Hospital and
      Ordu State Hospital between January 1, 2015 and June 30, 2015, and planned for total knee
      arthroplasty, were included. Patients who were allergic to local anaesthetics, had
      neurological disease, had infections in the intervention area, did not cooperate, or did not
      agree to the intervention were excluded from the study. After receiving informed consent from
      the patients, they were divided into two groups using the closed envelope method: the USA
      Group was the spinal anaesthesia (SA) group (n = 30), and the PCS group was the PCB and
      sciatic nerve block group (n = 30). All of the patients planned for surgery were monitored in
      terms of non-invasive arterial blood pressure, heart rate (HR) and peripheral haemoglobin
      oxygen saturation (SpO2). Peripheral vascular access was established using an 18-G cannula
      before the block operation, and 500 ml of 0.9% NaCl solution was infused for 20 minutes
      followed by the intravenous administration of 0.07 mg/kg midazolam (Dormicum®; Roche, Basel,
      Switzerland). The haemodynamic parameters were recorded every 5 minutes until the end of the
      preoperative and perioperative operation period. Next, 2 ml of hyperbaric bupivacaine
      hydrochloride (Marcain Heavy 0.5%; AstraZeneca®, London, UK) was administered to patients in
      the USA group in the lateral decubitus position, after regional sterilisation, through the
      selected intervertebral space (L4-L5 or L3-L4) using a 25-G Quincke spinal injector (B.
      Braun®, Melsungen, Germany). After remaining in this position for 15 minutes after the
      procedure, the patients were changed to the supine position. Patients in the PCS group were
      changed to the lateral decubitus (Simms) position. Following the sterilisation and covering
      procedures required for blockade of the lumbar plexus somatic nerves, the abdominal settings
      were selected on the ultrasound device (Mindray DC-T6 VET®, Shenzhen, China). The depth was
      set at 11-12 cm, and the frequency was set at 4-8 MHz. A convex ultrasonography (USG) probe
      was placed 4 cm laterally on the middle line at the L3-L5 level. The transverse process was
      longitudinally identified using an USG probe. The 'trident sign' (three-pronged spear
      appearance) acoustic shadow of the transverse process is characteristic. After viewing the
      psoas muscle at the depth of the transverse process, the needle was inserted using an
      out-plane approach. While using a nerve stimulator simultaneously (Stimupleks A; B. Braun®,
      Melsungen AG, Germany), the stimulation current was reduced to the 0.5-1.0 mA level when
      contraction of the quadriceps muscle was observed, and 20 ml of local anaesthetic (5 ml of 2%
      lidocaine + 15 ml of 0.5% bupivacaine) was injected. The local anaesthetic was observed to
      disperse around the lumbar plexus with USG. Sciatic nerve block was applied as follows: the
      patients' positions were not changed, and the skin was disinfected in the same position
      (lateral decubitus position). Following the required covering process, the USG settings were
      applied for optimum visualisation. The depth was set as 3-6 cm, and frequency as 2-8 MHz. The
      convex USG probe was placed in the subgluteal area in the transverse position. After
      determining the sciatic nerve, the injector was inserted into the lateral edge of the probe
      as in-plane and proceeded towards the nerve. When using the nerve stimulator simultaneously
      (Stimupleks A; B. Braun®), the stimulation current was reduced to 0.2-0.5 mA until
      contractions became visible. The local anaesthetic was observed to disperse around the
      sciatic nerve with USG by administering 20 ml of local anaesthetic (5 ml of 2% lidocaine + 15
      ml of 0.5% bupivacaine) following negative aspiration with the injector. The patients were
      changed to the supine position. Surgery was allowed when effective sensory block reached with
      at least a T10 dermatome.

      After the procedure, the patients were changed to the supine position. The application times
      of both techniques were recorded as the technique application times. While the analgesia
      level was evaluated using the pinprick test, the degree of motor block was assessed using the
      modified Bromage scale (0: no block, 1: hip flexion is blocked when the knee is extended, 2:
      knee flexion is blocked, 3: full motor block). Additionally, the sensory and motor blocks
      were evaluated at 5-minute intervals using the measurements of the haemodynamic parameters
      after the administration of medications. No case was excluded from the study because of block
      failure; thus, the data of all the cases in both groups were analysed.

      Surgical intervention was initiated after the development of a full motor block. The time
      from the beginning of surgical incision until the completion of the procedure was recorded as
      the operation period. A decrease in the mean basal arterial pressure of 25% or more was
      considered as hypotension; in this case, ephedrine was administered as 5 mg intravenously
      (i.v.), and 5 ml/kg additional crystalloid fluid was given. Heart rates less than 50
      beats/minute were considered as bradycardia, and atropine was administered as 0.5 mg i.v. All
      of the patients were administered 3 l/minute O2 through the mask and 5 ml/kg/hour maintenance
      crystalloid i.v. fluid during the surgery. The motor block return time and first analgesic
      requirement time were recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Postoperative VAS values
time frame: postoperative first 24 hour
description: Visual Analog Scale (mm)
measure: Perioperative Heart Rate
time frame: perioperative 150 minute
description: Beat to beat variability
measure: Perioperative Mean Arterial Pressure
time frame: perioperative 150 minute
description: mmHg
arm group label: Group USA
arm group type: Sham Comparator
description: (Marcain Heavy 0.5%; AstraZeneca®, London, UK) using a 25-G Quincke spinal injector (B. Braun®, Melsungen, Germany).
arm group label: Group PCS
arm group type: Active Comparator
description: (Stimupleks A; B. Braun®, Melsungen AG, Germany) to lumbar plexus in psoas muscle compartment (injected material 20 ml local anaesthetic mixture5 ml of 2% lidocaine + 15 ml of 0.5% bupivacaine)
%2 Aritmal ampul (Osel İlaç,Turkey) and Marcaine %0.5 flacon (AstraZeneca®, London, UK)
intervention type: Procedure
intervention name: intratechal (subarachnoidal )injection
description: 10 mg (2 cc) intrathecal single shot injection
arm group label: Group USA
other name: Marcaine Spinal 0,5 % Heavy ampule
intervention type: Procedure
intervention name: lombar plexus and sciatic nerve injection
description: USG -guided lumbar plexus visualised and 20 ml local anaesthetic mixture (15 cc %0,5 Bupivacaine Hydrochloride 5 cc and %2 Lidocaine 5 cc ) for lombar plexus single shot injection
arm group label: Group PCS
other name: Marcaine %0,5 20 cc flacon and Aritmal %2 ampule
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: T.C. ORDU ÜNİVERSİTESİ
investigator full name: Ebru Canakci
investigator title: M.D
mesh term: Bupivacaine
sharing ipd: Yes