xml: <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/NCT06003933</url>
    </required_header>
    <id_info>
      <org_study_id>m644</org_study_id>
      <nct_id>NCT06003933</nct_id>
    </id_info>
    <brief_title>Inter-semispinal Plane Block and Cervical Spine Surgery</brief_title>
    <acronym>ISPB</acronym>
    <official_title>Inter-semispinal Plane (ISP) Block for Postoperative Analgesia Following Cervical Spine Surgery: A Prospective Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yasser S Mostafa, MD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fayoum University Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The inter-semispinal plane (ISP) block is a novel ultrasound-guided technique that involves&#xD;
        local anesthetic injection into the fascial plane between the semispinalis cervicis and&#xD;
        semispinalis capitis muscles with subsequent block of the dorsal rami of the cervical spinal&#xD;
        nerves and hence can get adequate postoperative analgesia.&#xD;
  &#xD;
        The authors hypothesized that ISP block can reduce the postoperative analgesic consumption in&#xD;
        patients undergoing posterior cervical spine surgeries.&#xD;
  &#xD;
        The aim of this study is to evaluate the analgesic efficacy of ISP block in patients&#xD;
        undergoing posterior cervical spine surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will be performed in the in the Fayoum University hospital after the local&#xD;
        Institutional Ethics Committee and local institutional review board approval. The study&#xD;
        design will be double-blind randomized controlled study . A detailed informed consent will be&#xD;
        signed by the eligible patients before recruitment and randomization.&#xD;
  &#xD;
        Patients were randomly allocated into two groups using computer generated sequence and&#xD;
        concealed in sealed opaque envelopes.&#xD;
  &#xD;
        Control group (C): patients received general anesthesia only. Inter-semispinal plane (ISP)&#xD;
        block group: patients received bilateral ultrasound guided ISP block at the level of C5.&#xD;
  &#xD;
        All patients will be assessed Preoperative VAS score then premedicated orally with midazolam&#xD;
        0.5 mg/kg 30 min prior to surgery. All patients were monitored by 5 lead ECG, pulse oximetry,&#xD;
        non-invasive blood pressure and capnography and an intravenous (IV) access will be&#xD;
        established.&#xD;
  &#xD;
        The technique of general anesthesia will be standardized for all patients. General anesthesia&#xD;
        will be induced by intravenous (IV) 2 mg/kg propofol and 1 μg/kg fentanyl induction. After IV&#xD;
        atracurium 0.5 mg/kg, orotracheal intubation was performed. Anesthesia will be maintained&#xD;
        with isoflurane (1.2%-1.5%) in oxygen-air mixture (50%-50%). Muscle relaxation will be&#xD;
        maintained during the procedure with atracurium in increments.&#xD;
  &#xD;
        After induction of general anesthesia, ISP blocks will be performed in the allocated group&#xD;
        with the patient in the prone position. In both groups, the treating anesthesiologist left&#xD;
        the operating room while another anesthesiologist experienced in ultrasound guided nerve&#xD;
        block techniques; with no subsequent role in the study; either performed the ISP blocks in&#xD;
        the ISP group, or just prepared the skin and scanned the site of the block using the&#xD;
        ultrasound probe in the control group. Fifteen minutes will be awaited in all patients before&#xD;
        the surgical procedure was allowed to start.&#xD;
  &#xD;
        fentanyl 0.5 μg/kg IV will be administered in case of inadequate analgesia as indicated by&#xD;
        &gt;20% increase in heart rate or mean arterial blood pressure. Total intraoperative fentanyl&#xD;
        consumption will be recorded.&#xD;
  &#xD;
        All anesthetics will be discontinued at the end of the surgical procedure. Extubation will be&#xD;
        performed when spontaneous breathing was adequate and following prompt reversal using 0.05&#xD;
        mg/kg of neostigmine and 0.02 mg/kg of atropine. At the end of surgery, paracetamol 1 g will&#xD;
        be administered IV to be repeated every 6 h postoperatively. Patients will be transferred to&#xD;
        the PACU where HR, respiratory rate, SpO2 and systolic, diastolic and mean arterial blood&#xD;
        pressure were monitored.&#xD;
  &#xD;
        Sample size was calculated using G* Power 3.1.7.9 software program. Calculation of the sample&#xD;
        size was based on the VAS value measured at different time points. Based on the results of a&#xD;
        study by Mostafa et al, the authors calculated the sample size to be able to detect a&#xD;
        difference in VAS score of 10 points with an effect size of 0.8. Using the previous data, at&#xD;
        least 23 patients in each group were required to detect a significance difference in the&#xD;
        postoperative pethidine consumption at α value of 0.05 and study power of 90%. The authors&#xD;
        decided to recruit 25 patients in each group to compensate for any possible withdrawals. The&#xD;
        sample size calculation was based on a 2-sample independent t-test (2-sided)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 3, 2023</start_date>
    <completion_date type="Actual">September 10, 2023</completion_date>
    <primary_completion_date type="Actual">August 15, 2023</primary_completion_date>
    <phase>N/A</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>
      <intervention_model_description>Patients were randomly allocated into either of the two groups using computer generated sequence and concealed in sealed opaque envelopes.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>postoperative rescue pethidine consumption</measure>
      <time_frame>48 hours after operation</time_frame>
      <description>in milligram</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Postoperative visual analog pain score (VAS score)</measure>
      <time_frame>4 hours postoperatively</time_frame>
      <description>0 to 10 scale as 0: no pain and 10:worst degree of pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative visual analog pain score (VAS score)</measure>
      <time_frame>8 hours postoperatively</time_frame>
      <description>0 to 10 scale as 0: no pain and 10:worst degree of pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative visual analog pain score (VAS score)</measure>
      <time_frame>12 hours postoperatively</time_frame>
      <description>0 to 10 scale as 0: no pain and 10:worst degree of pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative visual analog pain score (VAS score)</measure>
      <time_frame>24 hours postoperatively</time_frame>
      <description>0 to 10 scale as 0: no pain and 10:worst degree of pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative visual analog pain score (VAS score)</measure>
      <time_frame>48 hours postoperatively</time_frame>
      <description>0 to 10 scale as 0: no pain and 10:worst degree of pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time to first rescue analgesic request</measure>
      <time_frame>1 minute after requiring analgesics</time_frame>
      <description>in milligram</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraoperative fentanyl consumption</measure>
      <time_frame>1 minute after surgery.</time_frame>
      <description>in microgram</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of postoperative nausea</measure>
      <time_frame>2 hours after operation</time_frame>
      <description>yes or no</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of postoperative vomiting</measure>
      <time_frame>2 hours after operation</time_frame>
      <description>yes or no</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of postoperative pruritis</measure>
      <time_frame>2 hours after operation</time_frame>
      <description>yes or no</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Age</measure>
      <time_frame>1 hour preoperatively</time_frame>
      <description>in years</description>
    </other_outcome>
    <other_outcome>
      <measure>body mass index</measure>
      <time_frame>1 hour preoperatively</time_frame>
      <description>kg/m2</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">50</enrollment>
    <condition>Post Operative Pain</condition>
    <condition>Cervical Spine Instability</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>patients received general anesthesia only.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ISP group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients received bilateral ultrasound guided inter-semispinal plane (ISP) block at the level of C5 using 10 ml of 0.25% bupivacaine and 10ml xylocaine on each side to reduce the toxicity</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacaine Hydrochloride</intervention_name>
      <description>10 ml of 0.25% bupivacaine on each side of cervical region at C5</description>
      <arm_group_label>ISP group</arm_group_label>
      <other_name>0.25% bupivacaine HCL</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Lidocaine Hydrochloride</intervention_name>
      <description>10ml xylocaine on each side of cervical region at C5</description>
      <arm_group_label>ISP group</arm_group_label>
      <other_name>Xylocaine</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Ultrasound</intervention_name>
      <description>The same anesthesiologist who is experienced in US guided regional anesthesia will perform the block.The five-layered posterior cervical muscles were identified at the level of C5 with a 6-15-MHz linear probe oriented in the transverse plane (SonoSite Edge, Bothell, Washington). The fifth cervical spine was counted from the C7 spinous process with the probe sliding cranially.</description>
      <arm_group_label>ISP group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Needle</intervention_name>
      <description>the needle (22- G, 50-mm block needle (Visioplex, Vygon) was introduced in-plane through the skin and advanced into the fascial plane between the semispinalis cervicis and semispinalis capitis muscles. After negative aspiration for blood, 20 ml of bupivacaine 0.25% was injected5.</description>
      <arm_group_label>ISP group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) physical status I-II undergoing elective&#xD;
               posterior cervical spine surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient refusal&#xD;
  &#xD;
            -  Patients with any contraindication to regional anesthesia (e.g. local infection,&#xD;
               coagulation abnormality)&#xD;
  &#xD;
            -  Known allergy to local anesthetics&#xD;
  &#xD;
            -  Previous cervical disc surgery or fixation&#xD;
  &#xD;
            -  Mental disorders&#xD;
  &#xD;
            -  Drug or alcohol abuse.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mohamed A Shawky, MD</last_name>
      <role>Study Director</role>
      <affiliation>Fayoum University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Fayoum University Hospital</name>
        <address>
          <city>Fayoum</city>
          <state>Faiyum</state>
          <zip>63514</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Kurd MF, Kreitz T, Schroeder G, Vaccaro AR. The Role of Multimodal Analgesia in Spine Surgery. J Am Acad Orthop Surg. 2017 Apr;25(4):260-268. doi: 10.5435/JAAOS-D-16-00049.</citation>
      <PMID>28291143</PMID>
    </reference>
    <reference>
      <citation>Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8.</citation>
      <PMID>30853517</PMID>
    </reference>
    <reference>
      <citation>Lumawig JM, Yamazaki A, Watanabe K. Dose-dependent inhibition of diclofenac sodium on posterior lumbar interbody fusion rates. Spine J. 2009 May;9(5):343-9. doi: 10.1016/j.spinee.2008.06.455. Epub 2008 Sep 14.</citation>
      <PMID>18790686</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Fayoum University Hospital</investigator_affiliation>
      <investigator_full_name>Yasser S Mostafa, MD</investigator_full_name>
      <investigator_title>Lecturer of anesthesia</investigator_title>
    </responsible_party>
    <keyword>inter-semispinal plane block</keyword>
    <keyword>Cervical spine surgery</keyword>
    <keyword>Postoperative analgesia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lidocaine</mesh_term>
      <mesh_term>Bupivacaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06003933
  org study id: m644
  nct id: NCT06003933
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The inter-semispinal plane (ISP) block is a novel ultrasound-guided technique that involves
        local anesthetic injection into the fascial plane between the semispinalis cervicis and
        semispinalis capitis muscles with subsequent block of the dorsal rami of the cervical spinal
        nerves and hence can get adequate postoperative analgesia.
  
        The authors hypothesized that ISP block can reduce the postoperative analgesic consumption in
        patients undergoing posterior cervical spine surgeries.
  
        The aim of this study is to evaluate the analgesic efficacy of ISP block in patients
        undergoing posterior cervical spine surgery.
  This study will be performed in the in the Fayoum University hospital after the local
        Institutional Ethics Committee and local institutional review board approval. The study
        design will be double-blind randomized controlled study . A detailed informed consent will be
        signed by the eligible patients before recruitment and randomization.
  
        Patients were randomly allocated into two groups using computer generated sequence and
        concealed in sealed opaque envelopes.
  
        Control group (C): patients received general anesthesia only. Inter-semispinal plane (ISP)
        block group: patients received bilateral ultrasound guided ISP block at the level of C5.
  
        All patients will be assessed Preoperative VAS score then premedicated orally with midazolam
        0.5 mg/kg 30 min prior to surgery. All patients were monitored by 5 lead ECG, pulse oximetry,
        non-invasive blood pressure and capnography and an intravenous (IV) access will be
        established.
  
        The technique of general anesthesia will be standardized for all patients. General anesthesia
        will be induced by intravenous (IV) 2 mg/kg propofol and 1 μg/kg fentanyl induction. After IV
        atracurium 0.5 mg/kg, orotracheal intubation was performed. Anesthesia will be maintained
        with isoflurane (1.2%-1.5%) in oxygen-air mixture (50%-50%). Muscle relaxation will be
        maintained during the procedure with atracurium in increments.
  
        After induction of general anesthesia, ISP blocks will be performed in the allocated group
        with the patient in the prone position. In both groups, the treating anesthesiologist left
        the operating room while another anesthesiologist experienced in ultrasound guided nerve
        block techniques; with no subsequent role in the study; either performed the ISP blocks in
        the ISP group, or just prepared the skin and scanned the site of the block using the
        ultrasound probe in the control group. Fifteen minutes will be awaited in all patients before
        the surgical procedure was allowed to start.
  
        fentanyl 0.5 μg/kg IV will be administered in case of inadequate analgesia as indicated by
        >20% increase in heart rate or mean arterial blood pressure. Total intraoperative fentanyl
        consumption will be recorded.
  
        All anesthetics will be discontinued at the end of the surgical procedure. Extubation will be
        performed when spontaneous breathing was adequate and following prompt reversal using 0.05
        mg/kg of neostigmine and 0.02 mg/kg of atropine. At the end of surgery, paracetamol 1 g will
        be administered IV to be repeated every 6 h postoperatively. Patients will be transferred to
        the PACU where HR, respiratory rate, SpO2 and systolic, diastolic and mean arterial blood
        pressure were monitored.
  
        Sample size was calculated using G* Power 3.1.7.9 software program. Calculation of the sample
        size was based on the VAS value measured at different time points. Based on the results of a
        study by Mostafa et al, the authors calculated the sample size to be able to detect a
        difference in VAS score of 10 points with an effect size of 0.8. Using the previous data, at
        least 23 patients in each group were required to detect a significance difference in the
        postoperative pethidine consumption at α value of 0.05 and study power of 90%. The authors
        decided to recruit 25 patients in each group to compensate for any possible withdrawals. The
        sample size calculation was based on a 2-sample independent t-test (2-sided)
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients were randomly allocated into either of the two groups using computer generated sequence and concealed in sealed opaque envelopes.
  primary purpose: Prevention
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: postoperative rescue pethidine consumption
  time frame: 48 hours after operation
  description: in milligram
  measure: Postoperative visual analog pain score (VAS score)
  time frame: 4 hours postoperatively
  description: 0 to 10 scale as 0: no pain and 10:worst degree of pain
  measure: Postoperative visual analog pain score (VAS score)
  time frame: 8 hours postoperatively
  description: 0 to 10 scale as 0: no pain and 10:worst degree of pain
  measure: Postoperative visual analog pain score (VAS score)
  time frame: 12 hours postoperatively
  description: 0 to 10 scale as 0: no pain and 10:worst degree of pain
  measure: Postoperative visual analog pain score (VAS score)
  time frame: 24 hours postoperatively
  description: 0 to 10 scale as 0: no pain and 10:worst degree of pain
  measure: Postoperative visual analog pain score (VAS score)
  time frame: 48 hours postoperatively
  description: 0 to 10 scale as 0: no pain and 10:worst degree of pain
  measure: time to first rescue analgesic request
  time frame: 1 minute after requiring analgesics
  description: in milligram
  measure: Intraoperative fentanyl consumption
  time frame: 1 minute after surgery.
  description: in microgram
  measure: Occurrence of postoperative nausea
  time frame: 2 hours after operation
  description: yes or no
  measure: Occurrence of postoperative vomiting
  time frame: 2 hours after operation
  description: yes or no
  measure: Occurrence of postoperative pruritis
  time frame: 2 hours after operation
  description: yes or no
  measure: Age
  time frame: 1 hour preoperatively
  description: in years
  measure: body mass index
  time frame: 1 hour preoperatively
  description: kg/m2
  arm group label: Control group
  arm group type: No Intervention
  description: patients received general anesthesia only.
  arm group label: ISP group
  arm group type: Experimental
  description: patients received bilateral ultrasound guided inter-semispinal plane (ISP) block at the level of C5 using 10 ml of 0.25% bupivacaine and 10ml xylocaine on each side to reduce the toxicity
  intervention type: Drug
  intervention name: Bupivacaine Hydrochloride
  description: 10 ml of 0.25% bupivacaine on each side of cervical region at C5
  arm group label: ISP group
  other name: 0.25% bupivacaine HCL
  intervention type: Drug
  intervention name: Lidocaine Hydrochloride
  description: 10ml xylocaine on each side of cervical region at C5
  arm group label: ISP group
  other name: Xylocaine
  intervention type: Device
  intervention name: Ultrasound
  description: The same anesthesiologist who is experienced in US guided regional anesthesia will perform the block.The five-layered posterior cervical muscles were identified at the level of C5 with a 6-15-MHz linear probe oriented in the transverse plane (SonoSite Edge, Bothell, Washington). The fifth cervical spine was counted from the C7 spinous process with the probe sliding cranially.
  arm group label: ISP group
  intervention type: Device
  intervention name: Needle
  description: the needle (22- G, 50-mm block needle (Visioplex, Vygon) was introduced in-plane through the skin and advanced into the fascial plane between the semispinalis cervicis and semispinalis capitis muscles. After negative aspiration for blood, 20 ml of bupivacaine 0.25% was injected5.
  arm group label: ISP group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Mohamed A Shawky, MD
  role: Study Director
  affiliation: Fayoum University
  facility: 
  country: Egypt
  citation: Kurd MF, Kreitz T, Schroeder G, Vaccaro AR. The Role of Multimodal Analgesia in Spine Surgery. J Am Acad Orthop Surg. 2017 Apr;25(4):260-268. doi: 10.5435/JAAOS-D-16-00049.
  PMID: 28291143
  citation: Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8.
  PMID: 30853517
  citation: Lumawig JM, Yamazaki A, Watanabe K. Dose-dependent inhibition of diclofenac sodium on posterior lumbar interbody fusion rates. Spine J. 2009 May;9(5):343-9. doi: 10.1016/j.spinee.2008.06.455. Epub 2008 Sep 14.
  PMID: 18790686
  responsible party type: Sponsor-Investigator
  investigator affiliation: Fayoum University Hospital
  investigator full name: Yasser S Mostafa, MD
  investigator title: Lecturer of anesthesia
  mesh term: Pain, Postoperative
  mesh term: Lidocaine
  mesh term: Bupivacaine
  sharing ipd: No